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Audits - Self/Internal, Vendor and Regulatory Inspections
Nov 2024
The ACH Network - Electronic Payments in Detail, ACH 101, ACH 201, and ACH 301
Oct 2024
Advanced CMC Masterclass - EU
Oct 2024
ESG Stress Testing MasterClass - EU
Sep 2024
Cell Bank Establishment & Testing MasterClass - EU
Sep 2024
Method Validation and Transfer with focus on the new ICH Q2(R2) MasterClass - US
Aug 2024
Microbiological Contamination Control MasterClass - US
Jul 2024
Automated Accessibility Testing - Selenium, JavaScript + WCAG 2.2
Mar 2024
GCP Inspection Readiness
Dec 2023
Implementation of a Successful Technology Transfer Process
Nov 2023
Advanced Stability Testing of Pharmaceuticals MasterClass
Oct 2023
Clinical Trials Quality & Inspection Updates
May 2023
Statistical Analysis for Process and Product Development
May 2023
Comparability for Biologics
Apr 2023
New ICH & EMA Quality Guidelines
Feb 2023
Statistics for Process Control
Feb 2023
ACFE Fraud Conference Canada
Nov 2022
Quality control for ATMPs and Biologics MasterClass
Oct 2022
Behavioural Good Manufacturing Practices MasterClass
Sep 2022
Advanced Stability Testing of Pharmaceuticals Asian MasterClass
Sep 2022
Understanding and Implementing a Quality by Design (QbD) Program
May 2022
Smart Food Safety Summit
May 2022
Successfully Investigating Deviations
Mar 2022
3-Hour Virtual Seminar on IQ, OQ, PQ in the Verification and Validation Process
Mar 2022
Quality Control Laboratory Compliance - cGMPs and GLPs
Feb 2022
Advanced CMC MasterClass
Feb 2022
Supplier and Contract Manufacturer Management
Jan 2022
Cleaning Validation for Pharma
Dec 2021
Signal and Risk Management in Pharmacovigilance MasterClass
Nov 2021
The OECD Principles of Good Laboratory Practices (GLP) MasterClass
Nov 2021
Clinical Document World
Nov 2021
Quality Conference: Ensuring Quality, Safety and Equity in a Virtual Era
Jul 2021
Benefit-Risk Assessment in Pharmacovigilance MasterClass
May 2021
Temperature Controlled Logistics in Pharma & Biotech
May 2021
Risk-Based Validation of Laboratory Computerised Systems MasterClass
May 2021
Global Clinical Quality Conference
Apr 2021
Risk Management in Medical Devices Industry
Mar 2021
Use People Analytics to Drive Innovation and Accelerate Your Workforce Planning
Feb 2021
Writing Effective SOPs for QMS
Dec 2020
Pharmacovigilance
Dec 2020
Big Data - Tools and Trends for Improving your Quality System
Dec 2020
Product Launch Excellence for Pharma & Biotech
Nov 2020
Product Complaints and Recalls Virtual Summit
Nov 2020
FDA`s Regulation of Regenerative Medicine including Stem Cell Treatments and Tissue Engineering Training
Oct 2020
International Food, Nutrition and Bioprocess Technology Conference (Food & Nutrition)
Oct 2020
Laboratory Inspection and Auditing
Oct 2020
Normality Tests and Normality Transformations: Explanations, Justifications, and Uses
Jun 2020
The Difference Between Food Safety and Branding Decisions
Jun 2020
Death by CAPA - Does your CAPA Program need a CAPA
Feb 2020
Statistical Analysis of Gages (Metrology)
Feb 2020
Useful Statistical Methods for Defining Product and Process Specifications
Feb 2020
Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)
Feb 2020
Audit Trail Generation and Review
Feb 2020
Confidentiality of Substance Use Disorder Patient Records; Complying with the New Federal Law 42 CFR Part 2
Nov 2019
Human Factors Engineering to Satisfy the New IEC 62366-1, -2
Aug 2019
Bad Standard Operating Procedures (SOPs) - Bad Training: Garbage In, Garbage Out
Aug 2019
Applying Computer System Validation to Mobile Applications
Aug 2019
IQ, OQ, PQ in the Verification and Validation Process
Aug 2019
Good Documentation Practice (GDocP) for FDA Regulated Industry
Aug 2019
Effective Supplier Management Programs
Aug 2019
Statistical Justification for Sample Size and the Use of Only 3 Lots for Process Validation
Aug 2019
Prescription and Over-the-Counter GMPs: Avoiding FDA Form 483 and Making the Best Decisions
Aug 2019
Requirements for IQ, OQ and PQ Quality Protocols
Aug 2019
Sample Quality Control with Molecular Diagnostics
Aug 2019
4-Hour Virtual Seminar on Batch Record Review and Product Release
Jul 2019
Big Data in FDA-Regulated Industry - Best Practices for Systematic Use
Jul 2019
Death by CAPA Does your CAPA Program need a CAPA
Jul 2019
Strategies for Speeding Up Formulation Development
Jul 2019
6-Hour Virtual Seminar on Adaptive Design for Clinical Trials
Jul 2019
4-Hour Virtual Seminar on Aseptic Processing and Validation
Jul 2019
Auditing Laboratory Data Systems
Jul 2019
Effective Records Management and Document Control for Medical Devices
Jul 2019
Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)
Jul 2019
Writing Validation Master Plans - Best Practices for Writing a Compliant Document
Jul 2019
Statistical Process Control - Keys to Prevent Process Variation and Ensure Quality
Jul 2019
Root Cause Analysis - Starting at the Beginning
Jul 2019
Implementation and Management of GMP Data Integrity
Jul 2019
Information – Governance, Risk, Compliance
Jun 2019
FDA Inspections: From SOP to 483
Jun 2019
Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC
Jun 2019
Top Process Validation Mistakes - And How to Avoid Them
Jun 2019
Risk-Based Environmental Monitoring (EM) Program
Jun 2019
FDA Quality System Inspection Technique (QSIT) Audits – Good Preparation Practices
Jun 2019
Effective Contamination Control and Environmental Monitoring Program
Jun 2019
Using Kanban JIT Systems to Run a Startup Plant
Jun 2019
Quality Control for Microbiological Media and Reagents
Jun 2019
Master Validation Plan - The Unwritten Requirements
Jun 2019
What is the harm in that? Risk Management 101
Jun 2019
Change Control according to GxP and GMP Requirements
Jun 2019
FDA`s Expectations from Supplier Management for GMP: Quality Agreements and More
Jun 2019
Solving Statistical Mysteries – What does the FDA want
Jun 2019
Equipment Qualification and Process Validation
Jun 2019
FDA`s 21 CFR Part 11 Add-on Inspections
Jun 2019
Good Laboratory Practices (GLPs) vs GMPs - Comparisons and Contrasts
Jun 2019
Data Governance for Computer Systems Regulated by FDA
Jun 2019
Best Practices to Obtain FDA Feedback Prior to 510(k) and De Novo
Jun 2019
Lyophilization Process Development and Cycle Design with a Case Study
Jun 2019
Using Learning Management Systems (LMS) to Develop Pharma Training - Rewards and Challenges
Jun 2019
Risk-Based Verification and Validation Planning to Meet US FDA and ISO 13485 Requirements
Jun 2019
Implementing a Compliant Stability Program for Biologics
Jun 2019
U.S. Adverse Event Reporting Regulations for Drugs, Dietary Supplements and Cosmetics
Jun 2019
Risk Analysis and HACCP
Jun 2019
How to Conduct Successful Supplier Audits
May 2019
NCMR Simplified - A One-Form, Easy-To-Complete, Method For Simplifying Your NCMR Process
May 2019
CDISC Mapping 4: SDTMs and ADAMs Examples (80%/20% Mapping Rule)
May 2019
Supplier and Service Provider Controls: FDA Expectations
May 2019
GxP/GMP Requirements and its Consequences for Documentation and Information Technology Systems
May 2019
New Elemental Impurities Tests for Pharmaceutical Products According to the New ICH Q3D and USP 232/233 Guidelines
May 2019
ICH Q7 FDA Guidance - Its Structure, History, Application and Writer`s Intent
May 2019
Supplier Quality Assurance Agreements: Why a General Supply Agreement Not Be Enough with Some Suppliers
May 2019
FDA`s Risk Evaluation and Mitigation Strategy (REMS)
May 2019
Ethylene Oxide (EO) Sterilization Basics for R&D Engineers
May 2019
Root Cause Failure Analysis Closed Loop Corrective Action
May 2019
Storm Water Pollution Prevention Plans (SWPPP)
May 2019
Establishing and Regaining Control of Cleanroom
May 2019
Transfer of Analytical Methods according to USP <1224>
May 2019
Implementing a Metrics Program - Uncovering and Overcoming the Challenges
May 2019
The Value of a Human Factors Program
May 2019
Auditing API Facilities: A MUST to properly prepare for an FDA Regulatory API GMP Inspection
May 2019
Label Claims for food, Probiotics and Cosmetic products in Brazilian Regulatory System
May 2019
How to Ensure Your Foreign Vendors are FDA Compliant: Conducting Vendor Audits, Monitoring, and Using Checklists
May 2019
Data Quality Culture and Building a Corporate Data Integrity Plan
May 2019
3-Hour Virtual Seminar on Best Practices to Help you Pass an FDA Computer System Validation Audit
May 2019
Quality by Design (QbD) in Pharmaceutical and Medical Device Manufacturing
May 2019
Good Manufacturing Practices – 3 Hour Virtual Seminar
May 2019
Pre-Formulation and Formulation Development of Small and Large Molecules for a Lyophilized Product
May 2019
Production and Process Controls - Ensuring your medical device conforms to its specifications
May 2019
Design History Files and Technical Files/Design Dossiers - Meeting U.S. FDA CGMPS and the EU`s MDD Requirements
May 2019
Supplier Qualification - Important Part of Quality Systems and Supply Chain Management
May 2019
Effective Records Management and Document Control for Medical Devices
May 2019
Statistical Hypothesis Tests: Concepts and Applications
May 2019
Stability Studies & Estimating Shelf Life
May 2019
Root Cause Analysis and CAPA using 8-D Problem Solving Method
May 2019
Quality Control for Microbiological Media and Reagents
May 2019
GMP Environmental Monitoring in Pharmaceutical Clean Rooms
May 2019
Compliance Measures for Case Managers
May 2019
3-Hour Virtual Seminar on SOP Writing, Training and Compliance in the Pharmaceutical Industry
May 2019
Essentials of Validation - IQ, OQ, PQ
Apr 2019
Continued Process Verification - A Systematic Approach
Apr 2019
How to Manage Your Vendors in Clinical Research
Apr 2019
Human Error Investigations, Root Cause Determination and CAPA Effectiveness
Apr 2019
Contemporary Case Management Staffing and Models: Best Practices in the Era of Value-Based Purchasing
Apr 2019
CDISC Mapping 3: Compare and Contrast SDTM and ADaM Steps
Apr 2019
Implementing a Quality Management System
Apr 2019
Risk Management in Clinical Research
Apr 2019
Estimating Reliability Performance with Accelerated Life Tests
Apr 2019
3-Hour Virtual Seminar on Safety Audits and Pharmacovigilance (PV) Inspections
Apr 2019
Monitoring and Validation of Pharmaceutical Water Systems
Apr 2019
How to conduct Annual Product Reviews to achieve GMP Compliance
Apr 2019
Root Cause Analysis
Apr 2019
ANDA Submission and GDUFA Final FDA Guidance
Apr 2019
Complaint Management: Best Practices to Assure Compliance and Customer Retention
Apr 2019
Lean Six Sigma and ISO 9001:2015
Apr 2019
Process Capability Analysis
Apr 2019
Technical Report Writing
Apr 2019
Reprocessing Reusable Medical Devices - Cleaning and Labeling Requirements
Apr 2019
IEC 62304 for Medical Device Software
Apr 2019
Practical Supplier Control Practices
Apr 2019
Constructing an Effective Argument
Apr 2019
510(k) and PMA Refuse to Accept Policy
Apr 2019
Sterile Filtration of Pharmaceutical Products – Validation and Regulatory Requirements
Apr 2019
Medical Device Laws and Regulations in Asia – Part 1 – China
Apr 2019
Medical Device Laws and Regulations in Asia – 2 Part Web-Series
Apr 2019
Test Method Validation to Verify the Performance of a Medical Device
Apr 2019
Internal Audit – How Best to Perform Them
Apr 2019
Effective Cleaning Validation Procedures – Best Practices
Apr 2019
In Depth Testing of Computer Systems Regulated by FDA
Apr 2019
Analytical Method Validation and Transfer
Apr 2019
Best Practices For A Compliant, Lean Supplier Management Program
Apr 2019
Understanding and Implementing a Technology Transfer Process
Apr 2019
Compliance with the New ICH GCP Revision 2 Addendum
Apr 2019
Sampling – How Large a Sample Do I Need? Determining the Right Size for Accurate, Cost Effective Results
Mar 2019
Verification, Validation and Compliance for Medical Device Software
Mar 2019
Risk Based Monitoring for GCP Compliance
Mar 2019
EO Sterilization Validation / Revalidation per ISO 11135
Mar 2019
Process Capability Analysis using Confidence or Reliability Calculations
Mar 2019
Regulatory and Testing Requirements of the Bacterial Endotoxin Testing (BET) or LAL Program
Mar 2019
Integrating Lean and Project Management
Mar 2019
Successful Change Control Management
Mar 2019
Human Error Reduction in GMP Related Environments
Mar 2019
The DIOM – A Straightforward Method for Meeting FDA Requirements for Design Inputs and Outputs
Mar 2019
Device Changes, FDA Changes, and the 510(k)
Mar 2019
EU and US GMP/GDP – Similarities and Differences
Mar 2019
FDA Regulation of Over-the-Counter (OTC) Drugs
Mar 2019
Using Metrics to Monitor and Improve Your Quality System
Mar 2019
Zero Acceptance Sampling to Reduce Inspection Costs
Mar 2019
Quality System Regulations for Combination Products
Mar 2019
FDA’s New Enforcement of 21 CFR Part 11
Mar 2019
FDA`s Scrutiny of Social Media Promotion
Mar 2019
Sterilization Processes - The Methods, Parameters and Deficiencies
Mar 2019
How to Write Effective 483 and Warning Letter Responses
Mar 2019
Implementing a Robust Data Integrity Program
Mar 2019
CMO Supplier Quality Agreements – How to Comply with New FDA and EU Guidelines for Contract Drug Manufacture
Mar 2019
Failure Modes and Effects Analysis - An effective Risk Management Tool
Mar 2019
How to Write Effective 483 and Warning Letter Responses
Mar 2019
Additive / 3D Printing Manufacturing and Its Regulatory Issues
Mar 2019
FDA Regulations for Environmental Monitoring (EM) Program
Mar 2019
Measurement Uncertainty in Microbiology
Mar 2019
Country of Origin Marking for Imports/Exports
Feb 2019
ISO 13485: 2016 Requirements and Compliance to Latest Updates
Feb 2019
FDA Compliance and Clinical Trial Computer System Validation
Feb 2019
Human Error and Cognitive Load: How to Reduce Memory and Attention Failures
Feb 2019
Is it Method Verification or Validation, or Just Semantics
Feb 2019
Medical Device Software 62304 Compliance
Feb 2019
Outstanding Leadership Through Social Intelligence
Feb 2019
Analytical Method Transfer According to USP General Chapter-1224
Feb 2019
Statistical Power – Understanding, Calculating, and How to Effectively Use it
Feb 2019
Introduction to Root Cause Investigation for CAPA
Feb 2019
Measurement Systems Analysis
Feb 2019
Complaint Handling Best Practices - Compliance with FDA and ISO Regulations
Feb 2019
Design Verification, Validation and Testing for Medical Devices
Feb 2019
Successful Water System Sanitization
Feb 2019
USP [1224] Transferring the Method to meet Regulatory Expectations
Feb 2019
How to Conduct a Quality Management System Audit to ISO/IEC 17025:2017
Feb 2019
Process Capability for Normal and Non-Normal Data
Feb 2019
Hazard Analysis and Product Risk Management Under ISO 14971 and ICH Q9
Feb 2019
Understanding FDA Design Verification and Validation Requirements for Medical Devices
Feb 2019
Effective Change Control Program – Challenges and Regulatory Requirements
Feb 2019
Confidence/Reliability Calculations of Product and Product Capability
Feb 2019
Complaint Handling, MDR`s & Recalls
Feb 2019
Achieving Success and Compliance in the Supply Chain
Feb 2019
ASTM 2500: Lessons Learned Through a Decade of Implementation
Feb 2019
What FDA-Regulated Industry Should Know about FDA’s New Policy on GMP Enforcement
Jan 2019
Statistical Process Control (SPC)
Jan 2019
How to Develop, Implement and Manage an Effective Change Control Program
Jan 2019
Risk Based Approaches for Clinical Trials
Jan 2019
ISO 13485:2016 - What are the hot topics and changes?
Jan 2019
Medical Device Cybersecurity and FDA Compliance
Jan 2019
QbD Development Process Evaluating Critical Steps
Jan 2019
Confirming your Compliance to ISO 13485:2016 Requirements
Jan 2019
Technical Writing for the Regulated Industries
Jan 2019
Translating Academic Assays for GLP Use
Jan 2019
Validation Master Plan - The Unwritten Requirements
Jan 2019
How to Prepare for an FDA Inspections?
Jan 2019
OOS Investigation & Root Cause Analysis
Jan 2019
Medical Marijuana in the Workplace
Jan 2019
Understanding Aseptic Technique and Cleanroom Behavior – Avoiding Human Error
Jan 2019
FDA and EMA Global Labeling Challenges and Requirements
Jan 2019
How to Use the FDA’s Final Guidance to Correctly Label Biosimilar Products
Jan 2019
Advanced Auditing Strategies to Detect and Mitigate Data Integrity Risks
Jan 2019
Writing Effective Standard Operating Procedure (SOPs) and Work Instructions (WIs)
Jan 2019
Selecting Right Statistical Tools to Solve Problems
Dec 2018
Developing IQ, OQ, PQ Protocols as Part of a Validation Plans
Dec 2018
Excel Spreadsheets for 21 CFR 11 Compliance
Dec 2018
Good Clinical Practices (GCP) Compliance – Audit Preparation and Inspection Readiness
Dec 2018
Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR
Dec 2018
FDA Regulations for Analytical Instrument Qualification and Validation – Comprehensive Best Practices
Dec 2018
Medical Devices - ISO 13485
Dec 2018
Complaint Handling Requirements – Interrelationship with CAPA, Change Control, Adverse Event Reporting and Recalls, Life Cycle Process Activities
Dec 2018
Implementing a Risk-Based Internal cGMP Annual Audit Program
Dec 2018
How to Perform a Thorough Root Cause Analysis and CAPA Development
Dec 2018
3-Hour Virtual Seminar on Writing Effective SOPs
Dec 2018
Quality Control for Analytical Materials used in Microbiology Laboratories
Dec 2018
Control-Analysis Instrumentation used in PAT Continuous Manufacturing
Nov 2018
Process Risk Management Strategies – Reduce Risk and COGS While Improving Yield and Compliance
Nov 2018
Risk Management Techniques for Medical Devices
Nov 2018
Auditing for Microbiological Aspects in Pharmaceutical Manufacturing
Nov 2018
Process Verification and Validation
Nov 2018
How to Conduct Successful Supplier Audits
Nov 2018
Good Documentation and Record Keeping Best Practices (FDA & EMA)
Nov 2018
Meet the Tougher U.S. FDA CGMPs
Nov 2018
Ensuring Integrity and Security of Laboratory Data
Nov 2018
Human Error Prevention in Pharmaceutical Manufacturing
Nov 2018
Conducting Successful Quality Audits
Nov 2018
Root Cause Analysis and Corrective Action
Nov 2018
Data Analysis in QSR - Techniques and Tools to avoid Warning Letter
Nov 2018
FDA’s Adverse Event Reporting and Product Recalls
Oct 2018
Requirements for IQ, OQ and PQ Quality Protocols
Oct 2018
Effective Quality by Design (QbD)
Oct 2018
Computer System Validation
Oct 2018
Introduction to Design of Experiments
Oct 2018
Sterilization of Pharmaceutical Products and Medical Devices
Oct 2018
Lean Improvements for Patient Safety
Oct 2018
Effective Batch Record Review
Oct 2018
Change Control Procedures in Regulated Industries
Oct 2018
Pharmaceutical Compressed Air - Quality GMP Requirements
Oct 2018
FDA`s New Draft Guidance on Software and Device Changes and the 510(k)
Oct 2018
Aseptic Process Overview and Validation
Oct 2018
Secrets to Writing Effective SOPs for Medical Device QMS
Oct 2018
Good Documentation Practice and Record Keeping Regulations (FDA & EMA)
Oct 2018
Troubleshooting Ethylene Oxide (EO) Processes
Oct 2018
Recent FDA Auditing Practices and the Top 10 Most Common Cited GMP Deficiencies
Sep 2018
Tougher Supplier Controls – Avoid Unwanted Changes
Sep 2018
cGMP Water Systems – Are You Ready for the FDA Inspection?
Sep 2018
Auditing and Qualifying Suppliers and Vendors
Sep 2018
FDA’s New Guidance’s Deciding When to Submit a 510(k) for Device and Software Changes
Sep 2018
Successful Computer System Validating and Control Using Managed Services SaaS, and Cloud Based Platforms
Sep 2018
Writing Effective Analytical Procedures
Sep 2018
System Suitability Testing (SST) for USP and FDA Compliance
Sep 2018
How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare
Sep 2018
cGMPs in the Quality Control Laboratory
Sep 2018
Quality Agreements Made Easy
Sep 2018
Line Clearance – Compliance Implications, Enforcement, and Best Practices
Sep 2018
Process Validation LifeCycle
Sep 2018
Chipping away at constraints – Practical tips to Improve your Manufacturing Operations
Sep 2018
CGMP controlled Raw Materials
Sep 2018
Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success
Sep 2018
21 CFR Part 11 - Compliance for Electronic Records and Signatures
Sep 2018
Regulatory Expectations for Environmental Monitoring Programs
Sep 2018
Laboratory Controls – Anticipate the Systems Based FDA Inspection
Sep 2018
Vendor Selection and Management
Sep 2018
Preparing for an FDA Inspection - What you Need to Know
Aug 2018
Tools for Human Error Reduction
Aug 2018
The Regulatory Expectations for Environmental Monitoring Programs
Aug 2018
FDA`s Revolutionary Change in Software Regulation
Aug 2018
Supply Chain Issues (21 CFR Part 820.50 and 820.80) and Warning Letters
Aug 2018
Process Validation – Principles and Protocols
Aug 2018
How to Ensure Your Foreign Vendors are FDA Compliant – Conducting Vendor Audits, Monitoring, and Using Checklists
Aug 2018
HACCP – Hazard Analysis and Critical Control Points
Aug 2018
HPLC Instrument Qualification and Method Validation
Aug 2018
Verification vs.Validation-Product,Process or Equipment and QMS Software
Aug 2018
Deciding When to Submit a 510(k) for a Change to an Existing Device
Aug 2018
FDA Compliant QC and QA Practices – Creating a Perfect, Audit-Ready QMS
Aug 2018
Excel Spreadsheets for 21 CFR 11 Compliance
Aug 2018
Design History File (DHF), Device History Record (DHR), Device Master Record (DMR) and Impact of Change Controls on Each
Jul 2018
Get Lean, NOT Mean – Secrets of the Toyota Production System
Jul 2018
Key Factors to Write an Effective Standard Operating Procedures (SOP) and Work Instructions (WI)
Jul 2018
New Revision of USP <1058>: Analytical Instrument Qualification
Jul 2018
Laboratory Investigations for Out of Specification Results
Jul 2018
Through the Eyes of an Auditor
Jul 2018
Root Cause Analysis (RCA) in the Laboratory - Addressing Non-Conformances
Jul 2018
Good Documentation Guideline (Chapter <1029> USP)
Jul 2018
How to Make Sure Your Foreign Vendors are FDA Compliant and Stay that Way
Jul 2018
Internal GMP Audit Program - Execution and Communication
Jul 2018
Develop a Compliant Validation Protocol and Analytical Procedures according to the FDA Guidance and USP Good Documentation Practices
Jul 2018
Understanding and Implementing USP [1058]: Analytical Instrument Qualification
Jul 2018
Developing a HACCP program that is effective, appropriate and compliant
Jul 2018
Biocompatibility Testing; what you need to know
Jun 2018
Food Fraud in the Organic Industry
Jun 2018
Overview of Medical Device Regulation in Europe
Jun 2018
Approaching unknown cause laboratory investigations using lean tools
Jun 2018
Stability Programs for Leachable Impurities
Jun 2018
Validation of GC/ GC-MS Methodologies
Jun 2018
Document Control and Change Control Process in GxP/GMP Environment
Jun 2018
Successful Supplier Audits
Jun 2018
Corrective and Preventive Action (CAPA) per FDA Requirements
Jun 2018
Off label Promotion of Drugs and Medical Devices - FDA`s Latest
Jun 2018
Does your QC lab do GMP and non-GMP activities?
May 2018
Current Regulatory Requirements for Sterile Products
May 2018
Document Control and Change Control Process in GxP/GMP Environment
May 2018
Health Product Marketing authorization in Brazil - Documentation, Approval Process, Labeling, Advertising and Post Market Vigilance
May 2018
Customs-Trade Partnership Against Terrorism (C-TPAT)
May 2018
How to Conduct a Human Factors - Usability Validation Test following ISO 62366 and the 2016 FDA Guidance
Apr 2018
Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities
Apr 2018
Differences Between ISO 13485 & ISO 9001 - and How to Choose Which One to Implement
Apr 2018
Quality Management and Quality Audit According to Gxp-GMP Requirements
Apr 2018
Medical Device Single Audit Program (MDSAP) Preparation
Apr 2018
Software Validation for the New FDA Inspections
Apr 2018
Discussion on Raw Material Methods and Specifications
Apr 2018
Predictive Warranty using Paynter Charts
Mar 2018
Management Control - Underutilized and Underappreciated
Feb 2018
Good Manufacturing Practices for Active Pharmaceutical Ingredients per ICH Q7
Feb 2018
Capturing Justifications in Change Control, Risk Assessment, Validations, and Investigation
Feb 2018
Trial Master File for Clinical Data Systems Regulated by FDA
Jan 2018
21 CFR Part 11 Compliance - Ensuring Data Integrity and Safety in Clinical Research
Jan 2018
Food Safety Modernization Act for Transportation and Logistics Professionals
Jan 2018
Modeling and Optimizing Process Behavior Using Design of Experiments
Jan 2018
Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices
Dec 2017
Equipment and Facility Qualification
Dec 2017
Analytical Method Validation Under Good Laboratory Practices - GLPs
Dec 2017
AAMI TIR 45: Agile Meets Software Standards, and we all Win
Nov 2017
Understanding, Calculating, and Using Statistical Power
Nov 2017
Virtual Seminar on Analytical Method Validation Process
Nov 2017
Compliance Requirements for Compounding Pharmacies Based on USP Chapters 795, 797, and 800
Nov 2017
Food Extrusion Processing Principles
Nov 2017
Lean Validation: Leveraging the NIST Cybersecurity Framework For Computer Systems Validation
Oct 2017
FDA Regulations for Analytical Instrument Qualification and Validation Processes
Oct 2017
Laboratory Instrument Calibration
Oct 2017
GLP Quality System Essences and Comparison with GMP
Oct 2017
Quality is not an Organization
Sep 2017
Time Series Analysis
Sep 2017
Document Control and Training
Sep 2017
Essentials of Validation -IQ,OQ,PQ
Sep 2017
Investigation of Out-Of-Specification Laboratory Results
Sep 2017
New Relationship between the Data Controller, Data Processor and the Data Subject
Sep 2017
Data Integrity and Its Issues
Sep 2017
Process Capability Analysis
Aug 2017
Excel Workbooks and FDA Device Regulations
Aug 2017
Device Accessories - Understanding and Implementing the Final Guidance Document
Aug 2017
Process Reliability Modeling: Driving Organizational Success
Aug 2017
FDA Regulations for Environmental Monitoring (EM) Program
Aug 2017
Effective Supplier Qualification Program
Aug 2017
Pharmaceutical Quality Risk Management (QRM) Overview
Jul 2017
Validation Master Planning and Regulatory Expectations
Jul 2017
Process Validation - Statistical Process Control
Jul 2017
Laboratory Accreditation: Getting there is just the beginning
Jul 2017
Demonstrating Product Reliability - Sample Sizes and Testing Times
Jul 2017
How to Perform Measurement Systems Analysis
Jul 2017
An Introduction to Risks associated with Extractables, Leachables & Elemental Impurities in cGMP Manufacturing: A Project Managers Perspective
Jul 2017
Creating a Good Design History File (DHF) for Audit Success
Jul 2017
Statistical Concepts of Process Validation
Jul 2017
Writing Effective Standard Operating Procedures and Work Instructions
Jun 2017
Effective Food Safety and Quality Training Programs – How to Educate, Motivate and Empower Your Employees
Jun 2017
Proper Execution of Annual Product Reviews
Jun 2017
Complaints, Servicing and FDA Reporting
Jun 2017
Elements of a CAPA System and Uses of CAPA Data
Jun 2017
USA and Canada Food Marketing Claims
Jun 2017
Proactive Internal Auditing -The Key to Establishing, Maintaining, and Improving Quality Systems
Jun 2017
Dos & Don`ts Related to Information Security and Data Privacy
Jun 2017
System Suitability, Allowable Adjustments, and Data Quality in Chromatographic Systems
Jun 2017
Recognizing and Managing Strategic Risks
Jun 2017
Steam Sterilization Microbiology and Autoclave Performance
Jun 2017
FDA Policy and Goals Regarding the 483 Response
Jun 2017
Elements of a Corrective and Preventive Action (CAPA) Program and Uses of CAPA Data
May 2017
Hypothesis Testing for Means - A Practical Approach
May 2017
Phase I GMPs
May 2017
Good Deviation Practice: What you need to know
May 2017
Supplier Evaluation and Assessment: How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner
May 2017
Medical Device Recalls: a Preventive Strategy
Apr 2017
ISO 13485:2016 Utilizing Lean Documents and Lean Configuration
Apr 2017
Understanding and Implementing USP 1058 Analytical Instrument Qualification
Apr 2017
Thriving with the Revised ISO 14001 Standard; Key Changes and Transition Strategies
Apr 2017
Introduction to Design of Experiments
Apr 2017
Packaging and Labelling for Clinical Products
Apr 2017
Efficient and Effective FDA and ISO Management Reviews
Apr 2017
Understanding Corrections and CA&PA
Apr 2017
Good Documentation Practices for FDA-Regulated Computer Systems
Apr 2017
Design Inputs Design Outputs Traceability Matrix
Apr 2017
1099-MISC: Block By Block Discussion
Apr 2017
Acceptance Sampling by Variables
Apr 2017
Inclusion of LGBT Employees in Healthcare: Navigating Policies, Procedures, and Practices
Apr 2017
Introduction to SPC (Statistical Process Control)
Apr 2017
Balancing Customer Satisfaction With Security Issues
Mar 2017
Risk Based Thinking in and Beyond ISO 9001:2015
Mar 2017
Lyophilization Technology
Mar 2017
Pharma Analytics – I Have All These Data, Now What Do I Do?
Mar 2017
Which Fringe Benifits are Taxable vs Non-Taxable
Mar 2017
Data Analysis in QSR
Mar 2017
Classifying Medical Devices - US and EU
Mar 2017
Understanding Proper Application of Risk Assessment
Mar 2017
Managing an FDA Inspection
Mar 2017
Medicare Quality Reporting Programs: Minding the Pitfalls with an Eye on the Horizon
Mar 2017
Compliance Trainings ASQ Certified Quality Engineer (CQE) Exam Preparatory Course
Mar 2017
Understanding and Overcoming Challenges Encountered in Implementing the New ISO 13485:2016 Standard for Medical Device Quality Systems
Feb 2017
Capturing Justifications in Change Control, Risk Assessment, Validations, and Investigations
Feb 2017
21 CFR Part 11 compliance for Electronic Medical Records
Feb 2017
Essentials of Complaint Handling and Medical Device Reporting
Feb 2017
Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil and Mexico
Feb 2017
Understanding Design Controls
Feb 2017
10 Keys for Maximizing the Benefits of your SPC Program
Feb 2017
Spotlight on Post Market Surveillance
Feb 2017
GMP Complaint Systems, Adverse Event Reporting and Product Recalls
Feb 2017
Surviving OSHA Audit in Six Easy Steps
Feb 2017
Putting the Quality in Audit Reports
Feb 2017
Techniques to engage information workers to improve Information Governance compliance
Feb 2017
How to conduct a Human Factors and Usability validation following ISO62366 and the new FDA Guidance
Feb 2017
Conducting Successful Product Complaint Investigations
Feb 2017
Supply Chain Data Integrity
Feb 2017
CAPA Training and Causes of Warning Letters due to Lack of Comprehension
Feb 2017
Best Practices for Effective Pharma Technology Transfer: From R&D to Clinical to Commercial
Jan 2017
The Marriage of the PFMEA and Control Plan
Jan 2017
Requirements for Registration of Medical Device Products in China
Jan 2017
USP 797/USP 795: Reviewing the Proposed Changes & How to Create and Manage a State of Control in Pharmacies
Jan 2017
SOP for Allergen Control Plan
Jan 2017
Chemistry 101 for Medical Device Regulatory & Quality Professionals: Essential knowledge needed to Manage Drug&Device Combination Product Project
Jan 2017
FDA Food Labeling Claims - Understanding the Advantages and the Risks of Claims
Jan 2017
Conducting Effective Investigations of Out of Specification and Atypical Laboratory Results
Jan 2017
Implementation of the Generic Drug Labeling Rules
Jan 2017
Judicial Imperative for Mitigating Recalls and Outbreaks in Food Industry
Jan 2017
Acceptance Sampling Plans for Process Validation and Production Lot Monitoring
Jan 2017
Internal Auditing as a Means to Operational Performance
Jan 2017
21 CFR Part 11 - Electronic Record and signature Validation
Dec 2016
Drive Continuous Improvement with Shingo Maps and ISO 9001:2015
Dec 2016
How to Handle HIPAA Security Incidents Breaches, Complaints, and Investigations
Dec 2016
OASIS C-2: Are you Prepared for the upcoming Changes Effective ?
Dec 2016
Quality and Compliance - Building Your Key Capabilities for Future Success
Dec 2016
Construction of the European Drug Master File (EDMF) for Regulatory Agencies - Webinar by GlobalCompliancepanel
Dec 2016
How to Manage a Medical Device Recall Efficiently and Effectively
Nov 2016
Challenges of Change Control: Implementation and Maintenance
Nov 2016
Traceability and Recall Through Food Processes
Nov 2016
Risks of Omission
Nov 2016
Standardizing Transportation Procedures to Control Food Safety and Quality
Nov 2016
Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)
Nov 2016
Key Success Factors to reduce your risk of FDA Citations
Oct 2016
Laboratory Instrument Calibration: Current FDA Regulatory Requirements and Best Practices
Oct 2016
Laboratory Investigation Out-of-Specification Results
Oct 2016
Acceptance Activities in FDA QSR
Oct 2016
MEDDEV 2.7.1, Revision 4 for Clinical Evaluation and the Latest Guideline: A Guide for Manufacturers and Notified Bodies
Oct 2016
Maintaining an Effective CAPA Program and Using Risk Assessment Tools: Current Trends
Oct 2016
Understanding Proper Labeling & Packaging Requirements & How to Stay Legally Compliant
Oct 2016
Production and Process Control: Building a Robust System for Medical Device Companies
Oct 2016
How to Conduct an Effective Annual Product Quality Review
Oct 2016
Quality Metrics Program: FDA Challenges and Requirements including the New `Quality Metrics Technical Conformation Guide` Released
Sep 2016
Regulatory Document – Site Master File
Sep 2016
Understanding Vendor Verification and Monitoring Programs for Food Manufacturing
Sep 2016
Setting and Measuring Quality Objectives
Sep 2016
Legal, Regulatory and Policy Issues Related to Computer System Validation as the FDA Regulates Tobacco Products
Sep 2016
Understanding the USP and FDA Functions in the Pharmaceutical Industry
Sep 2016
What Sample Size Do I Need?
Sep 2016
How to prepare for and Host FDA Inspection and Avoid 483`s
Sep 2016
FDA and CFIA-Overview of Proposed Regulations - Let`s Get Updated
Sep 2016
ASQ Certified Quality Engineer (CQE) Exam Preparatory Course - Webinar Series
Sep 2016
Responsible Recycling (R2) - Understanding the standard and the Benefits of Certification
Sep 2016
Reducing Drug and Device Batch Release Times: Improving your BPR/DHR Review and Assessment
Sep 2016
Handling, Storage, Distribution, and Installation of Medical Devices
Sep 2016
How to use Risk Based Process Safety`s skills to be in compliance with ICH-Q9 `Quality Risk Management` in the Pharmaceutical Industry
Sep 2016
Accelerated Aging Product Testing
Aug 2016
Clinical Trials be at Risk for Potential Fraudulent Billing. Conducting a Billing Risk Assessment and Coverage Analysis are Essential for Proper Billing.
Aug 2016
Changes to the Common Rule (45 CFR 46) : What this means for you
Aug 2016
Sampling Plan for Quality Audits
Aug 2016
How to do a Risk Analysis
Aug 2016
Customs-Trade Partnership Against Terrorism (C-TPAT) and Supply Chain Security
Aug 2016
FSMA Gives FDA Recall Authority Over Adulterated Food and Broadens Standards for Food Detention
Aug 2016
Evolving Regulatory Expectations for Data Integrity in GMP laboratory
Aug 2016
Laboratory Safety - Covering Issues such as Compressed Gases, Cryogenic Materials and Glassware, etc.
Aug 2016
What Sample Size Do I Need
Aug 2016
Service Level Agreements (SLAs) - Preparation Guidelines for Effective SLAs
Aug 2016
Failure Mode and Effects Analysis
Aug 2016
Good Manufacturing Practice for Nutraceuticals
Aug 2016
Controlling Food Safety Risks: Implementation and Audit in Accordance with FSSC 22000
Jul 2016
Considerations for a Successful Biosimilars Program
Jul 2016
TSCA Reform - What`s Next?
Jul 2016
FDA`s Emerging Signals Guidance: Reporting Medical Device Safety Warnings
Jul 2016
Using Analysis of Variance (ANOVA) - A Practical Approach
Jul 2016
Proper CAPA Management and Root Cause Analysis
Jul 2016
Human Factors/Usability Based on ISO 62366
Jul 2016
Laboratory Management with ISO/IEC 17025:2-Part Series
Jul 2016
Understanding and Implementing an Effective Laboratory Quality Management System to comply with ISO/IEC 17025
Jul 2016
USP <71> Sterility Testing: New Harmonization with International Compendia and Overview
Jul 2016
Integrating the GMPs with the Pharmaceutical Quality System (ICH Q10)
Jun 2016
21 CFR 111 GMP Dietary Supplement Laboratory
Jun 2016
Tools for Human Error Reduction: Developing Metrics and KPI`s (Key Performance Indicators) to minimize Human error rates
Jun 2016
Comparison of GFSI with FSMA requirements
Jun 2016
Understanding and Implementing the EU Vigilance System
Jun 2016
Gluten-Free Labelling with a Special Focus on Fermented, Hydrolyzed or Distilled Foods: How to Prove & Display It Correctly
Jun 2016
Electronic Data Integrity in a GxP Environment: Managing the Data Lifecycle for Compliance
Jun 2016
Reduce Inspection Costs with Sequential Sampling in ANSI/ASQ Z1.4
Jun 2016
Analytical Method Validation under Good Laboratory Practices (GLPs)
Jun 2016
Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue Based Products (HCT/Ps)
Jun 2016
Achieving Compliance with Robust CAPA Systems
Jun 2016
Simple Approach to Using Statistical and Other Data Tools to Enhance Your Quality Systems
May 2016
Lifecycle Approach to Analytical Methods: Incorporating QbD Principles into Method Development, Validation and Transfe
May 2016
Advertising and Promotional Material Compliance and Review Process
May 2016
Risk Management - Principles of Lean Documents and Lean Configuration
May 2016
Final FSMA Subpart G Rule Requirements for the Receiver Liability for Supplier Preventive Controls
May 2016
GMP Complaint Systems and Product Recalls
May 2016
Implementing Validation and Qualification - Annex 15 and FDA Requirements
May 2016
Party Vendor Risk Assessment for Financial Firms - Rules, Regulations and Best Practices
Apr 2016
Acceptance Sampling by Variables
Apr 2016
The Importance of the Investigator Responsibilities and Legal Commitments in Drug and Device Clinical Research in Achieving a Clean Audit
Apr 2016
Optimizing Target Weights for Foods and Beverages
Mar 2016
Ensuring Compliance of Your Bioanalytical Method Validation with the 2013 FDA Draft Guidance
Mar 2016
Obligations, Responsibilities and Warranties of the RDFI and ODFI for Special Processes: Returns & NOCs - the RDFI processes-Part 1
Mar 2016
Monitoring and Measuring Customer Satisfaction Using ISO 10004:2012
Mar 2016
Auditing Hospital-Physician Arrangements & Contracts under the New Stark Rules
Mar 2016
Antimicrobial effectiveness test USP [51] : Overview and New Content Proposals
Mar 2016
Strengthening Your Institutional Value Proposition
Feb 2016
Sampling Plans for Process Validation and Production Lot Acceptance
Feb 2016
Controlling Human Error in the Manufacturing Floor
Jan 2016
Good Social Media Practices to Avoid FDA Actions
Jan 2016
Established Condition - The New FDA Guidance
Jan 2016
Implementing a Change Control Quality System Successfully
Jan 2016
Statistical Process Control
Jan 2016
Safety Risk Assessment - How To Audit Safety Functions When You`re Not A Safety Professional?
Dec 2015
Tougher U.S. FDA cGMP Compliance Audits - When You`re Not Ready
Nov 2015
Big Data and its Importance to Quality And Compliance
Nov 2015
Unique Device Identifier (UDI) Implementation
Nov 2015
Effective Quality Audits: Digging Deep
Nov 2015
Building a Vendor Qualification Program for FDA Regulated Industries
Nov 2015
Establishing a Reduced Testing Process for Incoming Materials
Oct 2015
Establishing a Reduced Testing Process for Incoming Materials
Oct 2015
Risk Management in Clinical Trials
Oct 2015
Conducting Effective Quality Audits: Beyond Audit Checklists
Sep 2015
Introduction to Risk Assessment
Sep 2015
Basic Requirements for Developing IQ and OQ Protocols
Sep 2015
Understanding the Implications of FDA 483s and Actions to Avoid Further Regulatory Actions
Sep 2015
Applying Statistical Process Control Effectively
Aug 2015
Corrective Actions - Current Expectation of ISO 13485 and FDA Auditors
Aug 2015
ISO/FDIS 9001: - Planning for the Changes
Aug 2015
Understanding ISO 13485-FDA Requirements for Medical Devices
Aug 2015
Supplier Quality Agreements - Essential for Suppliers of Many Outsourced Processes
Aug 2015
Introduction to Bioresearch Monitoring
Jul 2015
Effective Crisis Management and Communications
Jul 2015
21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Configuration
Jul 2015
Validation of Complex Cell-Based Potency Methods
Jul 2015
A Risk-Based Methodology to Develop and Prepare an Effective Service Level Agreement (SLA) Package to Improve Service and Security Quality
Jul 2015
International Regulatory Cooperation Among Agencies
Jul 2015
Preparing for the LDT Regulation
Jul 2015
Canadian Establishment Licenses: Drugs, Supplements and Medical Devices
Jul 2015
Best Practices for Quality Risk Management for the Pharmaceutical Industry
Jun 2015
Manage Your FDA Inspection Before It Happens
Jun 2015
Preventing Product Liability - Key Areas Manufactures Need to Control
Jun 2015
Corrective and Preventive Action-Lean Management System
Jun 2015
Developing VMP-Master Validation Plan FDA
Jun 2015
Supplier Quality Management - Implement it Now or Pay for it Later
Jun 2015
Regulatory Inspections: The Art of Managing the Investigator
May 2015
Best Practices for Preparing for a Technical File for CE Mark
May 2015
Building a Sustainable Vendor Qualification Program
May 2015
Reduce the Risks of Foreign Material Contamination
Apr 2015
UDI Implementation
Apr 2015
Food Safety and Quality Planning
Apr 2015
Is it Method Verification or Validation, or Just Semantics?
Apr 2015
cGMPs in the Quality Control Laboratory
Apr 2015
Traceability Matrix - Principles of Lean Documents and Lean Configuration
Apr 2015
Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing
Feb 2015
Statistical Process Control (SPC)
Jan 2015
Managing Product Recalls in Accordance with Part 806
Dec 2014
ISO 14971:2012 - Does your current Risk Analysis still comply with your CE Mark requirements
Oct 2014
Electronic invoice and workflow and how it works with today`s ERP systems
Oct 2014
NQA-1 for non-QA Audit Personnel
Sep 2014
Maintaining a Validated State – PV, PM and Statistics associated with Current Regulation
Aug 2014
Role of Analytical support during various audits - Regulatory and Non Regulatory
Aug 2014
Designing for Safety to avoid Automobiles Recalls
Aug 2014
Quality System Regulation: Equipment and Facilities Controls Subsystem
Aug 2014
21 CFR Part 11 Add-On Inspections by the FDA
Jul 2014
Design Inputs - Design Outputs Traceability Matrix - Principles of Lean Documents and Lean Configuration
Mar 2014
Understanding ISO 13485 vs. ISO 9001 for Successful QMS in Medical Device Industries
Mar 2014
Implementing a Quality Program Using Compliance Measures With a Focus on Key Steps to Pass an ISO External Audit
Feb 2014
ICH Q10 Pharmaceutical Quality System
Feb 2014
Medical Devices and Pharmaceutical Quality Management System - Applying the Principles of Lean Documents and Lean C
Jan 2014
FDA Inspection: Preparation and Management
Jan 2014
Introduction to Process Capability
Jan 2014
Robust Corrective And Preventive Action (CAPA)
Nov 2013
Supplier Quality Agreements for Medical Devices
Nov 2013
510(k) for IVDs
Nov 2013
Unique Device Identification (UDI) Final Rules Overview
Nov 2013
IT Governance - What Policies, Plans and Procedures Should be Implemented for a Well-Managed IT Department
Oct 2013
Water System Mythology: Common False Beliefs for Microbial Control and Monitoring
Oct 2013
Risk Management for Medical Devices: ISO 14971:2007
Oct 2013
How to Manage a Medical Device Recall Efficiently and Effectively
Jul 2013
How to Withstand an FDA Audit of your Facility
Apr 2013
Complaint Handling in Compliance with FDA and ISO Regulations
Apr 2013
Quality Practices for Research and Development (R&D) CMC Laboratories
Mar 2013
Microbiological Risk: Do I Really Need to Test Raw Materials for Microorganisms
Mar 2013
How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant
Mar 2013
Auditing Technology and IT Investment Management
Feb 2013
Immunogenicity to biologics: processes, impact on efficacy and safety, and management strategy
Feb 2013
The Toolbox for CAPA and Risk Management
Jan 2013
FAA (SMS) - Implementation Guidance for Equipment/Service Providers
Jan 2013
Pharma and Biopharma Quality System Refresher Course
Jan 2013
Statistics in Quality Control: Critical Decisions - Risks & Basics
Dec 2012
Good Deviation Practice: what you need to know
Nov 2012
Efficient, Effective and Compliant Documentation in the QC Laboratory
Nov 2012
Introduction to Biotechnology Analytical Methods
Oct 2012
Basic and Advanced Quality Tools: What Every Quality Professional Should Know?
Oct 2012
(QMS) Competence and Training Requirements per FDA QSR and ISO 13485
Aug 2012
Process Validation - Webinar By ComplianceOnline
Jun 2012
Excel Spreadsheet Validation To Eliminate 483s - Webinar by GlobalCompliancePanel
Jun 2012
Service Level Agreements (SLAs) - Preparation Guidelines for Effective SLAs - Webinar By ComplianceOnline
Jun 2012
The Hero of Manufacturing Contamination Control - The Microbiology Lab
Apr 2012
Lean Project Management For U.S. FDA-Regulated Industries
Apr 2012
Applying Quality and Process Excellence in Pharma
Apr 2012
Modeling and Optimizing Process Behavior using Design of Experiments
Apr 2012
Making Risk-Benefit Decisions – Preparing for the New FDA Guidance Documents
Apr 2012
Implementing the New USP Chapter <1224> for Analytical Method Transfer
Mar 2012
Validation of Bioanalytical Methods and Procedures for FDA Compliance
Mar 2012
Predicting Warranty Expense Using Reliability Analysis Methods
Mar 2012
Validation of Analytical Procedures for Use in the Pharmaceutical Industry
Feb 2012
FDA/EU Compliant Training for Laboratory Personnel
Feb 2012
Quality System Approach and Risk Management for Clinical Trials
Feb 2012
Does your pharmaceutical lab have GMP and non-GMP functions?
Feb 2012
Setting up an effective Internal Audit Program
Feb 2012
Quality by Design (QbD) for Development and Validation of Analytical Methods
Jan 2012
Record Keeping for a (Food) Recall: Keeping Records to Minimize the Affect of a Recall
Jan 2012
The Odds are Against Auditing: Statistical Sampling in Audit
Jan 2012
How to Audit remotely using Online Auditing Techniques
Jan 2012
NLEA Regulation for Retail and Foodservice Labeling - Government Mandate and Additional Verbiage to Increase Food Safety and Brand Protection
Jan 2012
FDA Compliant Handling of Out of Trend Results in Pharmaceutical Quality Control
Dec 2011
Live webcast on HOW TO MANAGE COMPLAINT FILES by Compliance2go
Dec 2011
GMP Annual Training
Dec 2011
Live webinar on Excel Spreadsheet Compliance with 21 CFR 11 by Compliance2go
Dec 2011
Lyophilization Process Development and Cycle Design
Nov 2011
Excel Spreadsheets and FDA Device Regulations - Webinar by GlobalCompliancePanel
Oct 2011
Does your Equipment Program Meet Current Regulatory Expectations - Webinar By GlobalCompliancePanel
Oct 2011
Live webianr on Basic and Advanced Quality Tools: What every quality professional is expected to know by compliance2go
Oct 2011
FDA`s Draft Guidance on Financial Disclosure by Clinical Investigators - Webinar By GlobalCompliancePanel
Oct 2011
Introduction to Contamination Control Master Plans - Webinar by GlobalCompliancePanel
Oct 2011
The Drug Development Path - From R&D to Commercialization - Webinar by GlobalCompliancePanel
Oct 2011
Motivating Employees for Winning Performance - Webinar By TrainHR
Sep 2011
Good Laboratory Practice Regulations: Introduction and Strategies for Implementation
Sep 2011
Proper Identification and Payment of Exempt Employees - Webinar By TrainHR
Sep 2011
Drug Master Files (DMFs) - Understanding and Meeting Your Global Regulatory and Processing Responsibilities By compliance2go
Sep 2011
Applying GMP Quality Principles to Deviations & Nonconformities and Effective Corrective And Preventive Action Systems
Sep 2011
Ensuring Integrity and Security of Laboratory Data
Sep 2011
How to design A CAPA System that meets Compliance Requirements
Sep 2011
Stability Testing Training Online
Aug 2011
FDA Requirements for Device Labeling: Development, Contents, Distribution, and Changes - Webinar by GlobalCompliancePanel
Aug 2011
Effective Employee Performance Documentation: Elements and Techniques - Webinar By TrainHR
Jul 2011
Master Production Record Requirements - Webinar By GlobalCompliancePanel
Jun 2011
Webinar on Specification Development - Webinar By GlobalCompliancePanel
Jun 2011
Understanding good Closed Loop CAPA system - Webinar By GlobalCompliancePanel
Jun 2011
Risk-Based Validation for GxP Facilities - Webinar By GlobalCompliancePanel
Jun 2011
`The Right Stuff` – Implementing Quality Control Tools in Quality Systems Operations
May 2011
Test Method Validation - The Characteristics- Webinar By GlobalCompliancePanel
May 2011
Designing and Implementing the Quality System for Combination Products - Webinar By GlobalCompliancePanel
May 2011
Best Practices for the Implementation and Use of Test Management Tools - Webinar By GlobalCompliancePanel
Apr 2011
How to successfully create a Device History Record and keep FDA happy in the process - Webinar By GlobalCompliancePanel
Apr 2011
Designing appropriate product specifications for lyophilized parenteral products
Apr 2011
An Advanced course on Lean Documents and Document Control
Apr 2011
US FDA requirements for food contact packaging material compliance
Apr 2011
Understanding Attribute Acceptance Sampling including Z1.4 and c=0 Plans - Webinar By GlobalCompliancePanel
Apr 2011
ComplianceOnline Webinar - Why and How - Verification of Compendial Methods - USP [1226]
Apr 2011
Design Control Explained - Medical Device Webinar
Mar 2011
21 CFR Part 11 Compliance; specifics needed to eliminate 483s
Feb 2011
Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations - Webinar By GlobalCompliancePanel
Feb 2011
21 CFR Part 212: Quality Systems to Ensure cGMP Compliance
Feb 2011
Food Safety Management Systems - ISO 22000:2005 - Webinar By GlobalCompliancePanel
Feb 2011
Internal Audits: Maintaining your Quality Systems at the Ready - Webinar By GlobalCompliancePanel
Feb 2011
Utilizing Good Requirements as a Foundation for the Effective Validation of PDMA-related Computerized Systems - Webinar By GlobalCompliancePanel
Feb 2011
How to transfer QC procedures for commercial products in pharma industry - ICH and USP guidelines
Feb 2011
Design Validation Protocol and Acceptance Criteria for Chromatographic Methods to meet ICH requirements 2010
Jan 2011
The Auditee Bill of Rights - ComplianceOnline Quality Management Webinar
Jan 2011
Establishing Global Drug Substance and Drug Product Specifications – What the Guidelines Don’t Tell You
Jan 2011
Quality and Food safety - Problem Solving Methods (Steps, Tools & Success Key Factors) - ComplianceOnline Food Safety Webinar
Jan 2011
FDA 483 Observations in the Laboratory. What went wrong? How can they be avoided? - Webinar By GlobalCompliancePanel
Jan 2011
The Process Approach to Auditing - Webinar by GlobalCompliancePanel
Jan 2011
A Comparison of ICH Q-10 Quality System and the FDA`s Quality Systems Approach (QSA) to the Pharmaceutical GMPs - Webinar By GlobalCompliancePanel
Jan 2011
Auditing for Virtual Team Issue Escalation and Problem-Solving in global environment
Jan 2011
Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations
Dec 2010
Food Safety Traceability Systems – recall traceability capabilities, costs and trends - ComplianceOnline Food Safety Webinar
Dec 2010
ISO 13485 as a Quality Management System for Medical Devices - Webinar By GlobalCompliancePanel
Dec 2010
The Advantages of Linking Management Systems - Webinar By GlobalCompliancePanel
Dec 2010
Validation and Use of Excel Spreadsheets in FDA Regulated Environments - Webinar by GlobalCompliancePanel
Dec 2010
Audit Committee Responsibilities for Internal Controls - Webinar By GlobalCompliancePanel
Dec 2010
The FDA`s Working Group Reports, I & II - New Directions - Webinar By GlobalCompliancePanel
Dec 2010
Understanding Analytical Test Results: Comparing Two Sets of Data - Webinar by GlobalCompliancePanel
Dec 2010
Recalls of Medical Devices in the US
Dec 2010
Basics of OTC Drug Labeling Compliance - Webinar By GlobalCompliancePanel
Dec 2010
The Riskability Integration. – Integrating strategies and HR in EGRCM. Steps to leverage the impact of EGRCM mandates
Dec 2010
Introduction to Operational Risk - Webinar by GlobalCompliancePanel
Dec 2010
Know Your Customer - The DEA Due Diligence - Webinar By GlobalCompliancePanel Conference
Nov 2010
QSR Device Inspections – Transition from “Barely Surviving” to “Gaining Control”
Nov 2010
Root Cause Analysis: Shutting Down the Alligator Farm - Webinar by GlobalCompliancePanel
Nov 2010
Full Day Virtual Seminar - Reduce Software Validation Costs and Pass the New 21 CFR Part 11 Inspections - by GlobalCompliancePanel
Nov 2010
Good Documentation Practices in a Regulated Environment - Webinar by GlobalCompliancePanel
Nov 2010
Risk Management in IEC 60601-1 Edition - Webinar by GlobalCompliancePanel
Nov 2010
Full Day Virtual Seminar - Designing and Implementing the Quality System for Combination Products
Nov 2010
Training Requirements and Practices to Assure QSR and ISO Compliance - Webinar by GlobalCompliancePanel
Nov 2010
Auditing API Manufacturers and Suppliers - Webinar by GlobalCompliancePanel
Nov 2010
Interfacing Design Verification, Process Validation and Design Validation - Webinar by GlobalCompliancePanel
Nov 2010
The Virtual Contact Center Conference
Nov 2010
HIPAA Compliance and Workforce Training for Medical Practices - Webinar by GlobalCompliancePanel
Nov 2010
Crisis Management and Risk Communication - Webinar by GlobalCompliancePanel
Nov 2010
How to Prevent Food Safety Problems Using Your Current Quality System - Webinar by GlobalCompliancePanel
Nov 2010
How to Write Standard Operating Procedures (SOPs) and Work Instructions (WIs) - Webinar by GlobalCompliancePanel
Nov 2010
21 CFR Part 11 - What you need to know to pass the new FDA audits - Webinar by GlobalCompliancePanel
Nov 2010
Project Management for the Phase 3 & LCM (Life Cycle Management) of the Drug Development Process - Webinar by GlobalCompliancePanel
Nov 2010
Controlling Change to meet GMP Requirements
Nov 2010
Comparability Protocols (CPs): How and when to use them for POST APPROVAL CHANGES
Oct 2010
FDA`s Update on Medical Device Labeling Changes - Webinar by GlobalCompliancePanel
Oct 2010
ComplianceOnline Virtual Seminar - Effective Corrective and Preventive Actions (CAPA): 10 Steps to Success
Oct 2010
ICH Q7 Guidelines and Practical Approaches to Manufacturing APIs - Webinar by GlobalCompliancePanel
Oct 2010
The Most Common Problems in FDA Software Validation & Verification - Webinar by GlobalCompliancePanel
Oct 2010
Validation Basics A-Z: Planning, Implementing & Maintaining
Oct 2010
ComplianceOnline Virtual Seminar - 21 Cfr Part 11: Complete Manual For Compliance Success
Oct 2010
BRC Risk Analysis - Webinar by GlobalCompliancePanel
Oct 2010
ComplianceOnline Webinar - Gamma Sterilizer Validation: Method 1 and VDmax25 per ISO 11137 ()
Oct 2010
Revamping the 510(k) Clearance Process-Understanding FDA`s Proposals - Webinar by GlobalCompliancePanel
Oct 2010
Medical Device Classification - Webinar by GlobalCompliancePanel
Oct 2010
The ICF Process: Tips on Achieving Optimal compliance and Comprehension - Webinar by GlobalCompliancePanel
Oct 2010
The Tougher U.S. FDA - One Year Later
Oct 2010
ComplianceOnline Webinar - Estimating Greenhouse Gas Emissions; Determining Your Carbon Footprint
Oct 2010
European Drug Safety and Pharmacovigilance Compliance - Webinar by GlobalCompliancePanel
Oct 2010
Master Verification and Validation Planning to Meet US FDA, ISO 13485 and 14971:2009 Requirements - Webinar by GlobalCompliancePanel
Oct 2010
ComplianceOnline Webinar - Preparing for and handling FDA Laboratory GMP inspections
Oct 2010
ComplianceOnline Webinar - Importance of Method Validation Protocols and components of MVP in the Laboratory
Oct 2010
The HITECH Acts Impact on HIPPA - Webinar by GlobalCompliancePanel
Oct 2010
Regulatory Complaint Handling, MDR`s & Recalls - Webinar by GlobalCompliancePanel
Oct 2010
Using SLAs to Facilitate Enterprise and IT Governance, Risk Management and Compliance (GRC) - Webinar by GlobalCompliancePanel
Oct 2010
Introduction to Risk Management - Webinar by GlobalCompliancePanel
Oct 2010
Document Approval, Control, and Distribution: How to Meet FDA QSR and ISO 13485 Requirements in a Cost Effective Manner - Webinar by GlobalCompliancePanel
Oct 2010
What exactly is required for 21 CFR Part 11 compliance?
Oct 2010
Best Practices for Writing an Effective SOP to Lead to Successful FDA Inspections
Oct 2010
Integrating Clinical Evaluation and Risk Management (ISO 14971)
Oct 2010
Secrets of an Effective CMC Regulatory Strategy for Biopharmaceuticals Part 1 - Cell Banking - Webinar by GlobalCompliancePanel
Oct 2010
21 CFR Part 11: How to Successfully Prepare for and Host an FDA Inspection - Webinar by GlobalCompliancePanel
Oct 2010
Signal Detection and Case Processing: Business Process Optimization in Pharmacovigilance - Webinar by GlobalCompliancePanel
Oct 2010
Active and Intelligent Packaging Technologies: A Food Safety and Quality Perspective
Oct 2010
Best Practices for Managing FDA Investigators and Handling FDA 483 Observations
Sep 2010
How to Survive a DEA Audit or FIND=FINE - Webinar by GlobalCompliancePanel
Sep 2010
Development, Management, and Operation of an Effective Supplier and Internal Auditing System - Webinar by GlobalCompliancePanel
Sep 2010
Managing Product Medical Device Recall Efficiently and Effectively - Webinar by GlobalCompliancePanel
Sep 2010
Critical Role of Quality Audit in GxP Compliance & Improvement
Sep 2010
What to Expect in a Food Safety Audit
Sep 2010
The FDA Tripod - Clinical Trial Regulations, Compliance and GCP in Drug Development - Webinar by GlobalCompliancePanel
Sep 2010
Robust Process Validation for Medical Devices - Webinar by GlobalCompliancePanel
Sep 2010
Why Medical Device Companies Receive Warning Letters - Webinar by GlobalCompliancePanel
Sep 2010
Validating Radiation Sterilization for medical device industries
Sep 2010
Preparing for and Surviving an FDA Inspection - Webinar by GlobalCompliancePanel
Sep 2010
Outsourced processes and ISO 9001:2008 - Webinar by GlobalCompliancePanel
Sep 2010
Understanding and Preparing for FDA`s New Part 11 Inspection Program
Sep 2010
CAPA for Manufacturing, Financial Service Companies: Get it Right the Time (Efficient Process)
Sep 2010
Effective Quality Process Improvement for Medical Device Firms: Don’t get caught managing process through standardized SOP’s
Sep 2010
Environmental and Product Compliance - Sustainability - Webinar by GlobalCompliancePanel
Sep 2010
Preparing for FDA Inspections in a Changing Regulatory Environment - Webinar by GlobalCompliancePanel
Sep 2010
The Cosmetic-Cosmeceutical Distinction: Walking the Line in Developing Label Claims - Webinar by GlobalCompliancePanel
Sep 2010
Compiling the Design History File, and Technical File / Design Dossier - Webinar by GlobalCompliancePanel
Sep 2010
Developing Supplier Quality Auditor Training Programs
Sep 2010
Auditing Computer System Validation Materials - Webinar by GlobalCompliancePanel
Sep 2010
Quality by Design (QbD) and Analytical Methods - Webinar by GlobalCompliancePanel
Sep 2010
ComplianceOnline Webinar - Medical Device Changes and The 510(k)
Sep 2010
Medical Devices in the EU: CE Mark and 93/42/EEC Directive
Sep 2010
Risk Assessments - Key to a Viral Safety Management Plan
Sep 2010
Troubleshooting ethylene oxide (EO) processes - Webinar by GlobalCompliancePanel
Sep 2010
The role of Analytical Program to Support Drug Development Process
Sep 2010
Physical Properties Analytical and Screening Techniques - Webinar by GlobalCompliancePanel
Sep 2010
Understanding Acceptance Activities for Medical Devices - Webinar by GlobalCompliancePanel
Sep 2010
Developing an ethylene oxide (EO) sterilization process for a product with limitations
Sep 2010
Key Factors to Write an Effective Standard Operating Procedure (SOP)
Sep 2010
ComplianceOnline Webinar - Controlling Change to meet GMP Requirements
Sep 2010
Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11 - Prepare Yourself for the upcoming FDA Part 11 Inspections - Webinar by GlobalCompliancePanel
Sep 2010
Signal Detection and Data Mining - Webinar by GlobalCompliancePanel
Sep 2010
Verification of Pharmacopeia Methods - Webinar by GlobalCompliancePanel
Sep 2010
Effective & Essential CAPA process to avoid FDA 483 - Webinar by GlobalCompliancePanel
Sep 2010
Key Modules of an Effective CAPA SOP - Webinar by GlobalCompliancePanel
Sep 2010
Corporate Governance & Compensation in Risk Management - Webinar by GlobalCompliancePanel
Sep 2010
Improving Sanitation Standard Operating Procedures in the Food Industry - Webinar by GlobalCompliancePanel
Sep 2010
Post-Design Medical Device Risk Management - Webinar by GlobalCompliancePanel
Sep 2010
Understanding Corrective and Preventive Action, and Elements of a CAPA System - Webinar by GlobalCompliancePanel
Sep 2010
Good Documentation Practices for GMP Operations - Webinar by GlobalCompliancePanel
Sep 2010
Improving Sanitation Standard Operating Procedures In the Food Industry
Sep 2010
Designing a Change Control System that Meets and Exceeds Compliance Requirements - Webinar by GlobalCompliancepanel
Aug 2010
Conducting Value Added Audits of Technical Service Providers - Webinar by GlobalCompliancepanel
Aug 2010
ComplianceOnline Webinar - Streamline Documentation System in Pharmaceutical Laboratory
Aug 2010
Product Risk Management - ISO 14971 and ICH Q9
Aug 2010
Changes to the EU Variation Rules, Classifications and Submittal Requirements
Aug 2010
Understanding International Standards for Medical Devices
Aug 2010
Document Approval, Control, and Distribution: How to Meet FDA QSR and ISO 13485 Requirements in a Relatively Paper-Free Manner
Aug 2010
Applying HACCP Principles for Food Processors
Aug 2010
Method Transfer of Analytical Methods - Webinar by GlobalCompliancepanel
Aug 2010
Use of Risk Management to Meet Requirements of IEC 60601-1 - Webinar by GlobalCompliancepanel
Aug 2010
Webinar on Pharmacovigilance Audit - by GlobalCompliancepanel
Aug 2010
Regulatory Requirements for Medical Device Calibration Programs - Webinar by GlobalCompliancepanel
Aug 2010
Importing and Exporting Medical Devices: A Primer on Regulatory Strategy and Requirements - Webinar by GlobalCompliancepanel
Aug 2010
A Guide for Compliance with Document Control Requirements for Food Manufacturers - Webinar by GlobalCompliancepanel
Aug 2010
Change Control and Logging in the PCI environment - Webinar by GlobalCompliancepanel
Aug 2010
Important Sterilization Information for Product Developers - Webinar by GlobalCompliancePanel
Aug 2010
Defining, Architecting and Managing Risk Assessments- Webinar by GlobalCompliancePanel
Aug 2010
Auditing a Process-based System - Webinar by GlobalCompliancePanel
Aug 2010
Failure Modes and Effects Analysis (FMEA) - An Effective Tool for Medical Device Risk Management - Webinar by GlobalCompliancePanel
Aug 2010
Pharmaceutical Manufacturing Batch Record Review -Webinar by GlobalCompliancePanel
Aug 2010
Conduct Your Own Risk Assessments Following ISO Standard 31000/31010
Aug 2010

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