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ComplianceOnline organizes international conferences, seminars, workshops and other events in various fields, including business, education, government, global issues, health, medicine, industry, lifestyle and science....

ComplianceOnline has a presence in more than 20 countries around the world, including, Australia, Austria, Bangladesh, Brazil, China, Ireland and Kuwait.

ComplianceOnline hosts events on a wide range of topics, such as Aerospace, Agriculture, Alternative medicine, Anaesthesiology, Architecture, Interior design, Artificial Intelligence (AI) and Banking, among others. The events are designed to provide a platform for professionals and others to exchange knowledge, network, discuss new developments in respective fields as well as showcase products and services to a targeted audience.

Related topics
Showing 398 conferences
FDA`s Medical Device Software Regulation Strategy
Jun 2023
Statistical Analysis for Process and Product Development
May 2023
Quality Control Laboratory Compliance - cGMPs and GLPs
Apr 2023
Statistics for Process Control
Feb 2023
Latin America - Understanding Regulatory Compliance Requirements Across the Life Science Industry (Pharmaceuticals, Biologics, Medical Devices, IVDs)
Dec 2022
Change Control Best Practices - Avoiding Unintended Consequences of Changes
Jul 2022
Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices
Nov 2021
Data Integrity: FDA/EU Requirements and Implementation
Sep 2021
ComplianceOnline Medical Device Summit
Aug 2021
Risk Management in Medical Devices Industry
Jun 2021
Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)
Mar 2021
FDA`s GMP Expectations for Phase IV and -in-Man Clinical Trials
Dec 2020
FDA Audit, Quality Assurance Practices, Responsibilities and Expectations
Sep 2020
The A to Z`s of Microbial Control, Monitoring and Validation of Water Systems for Pharmaceuticals, Biologics, Medical Devices, Cosmetics, and Personal Care Products
Sep 2020
Issues in Calibrations and Accuracy in Method Validation
Jun 2020
Pharmaceutical Quality Management System (GMP Requirements, ICH Guidance, QbD, and USFDA/EMA Regulations)
Apr 2020
Quality and GMP Compliance for Virtual Companies (Pharmaceutical, Medical Device & Biologics Industries)
Feb 2020
Analytical Instrument Qualification and System Validation
Feb 2020
You have a BI Positive or Product Sterility Positive - Now What
Nov 2019
Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)
Nov 2019
eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada
Nov 2019
Designing and Sustaining New and Existing Product Stability Testing Program
Sep 2019
CDISC Mapping 5: ADAM Models - ADSL, BDS and ADAE
Sep 2019
How to Investigate Environmental Monitoring Excursions
Sep 2019
Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines
Sep 2019
Identify and Manage Data Integrity Issues, CSV and 21 CFR Part 11
Sep 2019
Exploring Data Integrity To Include FDA, WHO and EMA`s Latest Guidance for Industry (/)
Sep 2019
Implementing UDI (Unique Device Identification) - Plan Now for Success
Sep 2019
GMP Compliance for Quality Control and Contract Laboratories
Aug 2019
Clinical Data Management (FDA E6 GCP Guidelines)
Aug 2019
Aseptic Processing Overview and Validation
Jul 2019
Process Validation - Overview of Why and How
Jul 2019
PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation
Jul 2019
Basics of Testing Associated with Sterilization Validation and Routine Processing
Jul 2019
Essentials Of USP Microbiology - Reading Between the Lines of the USP General and Information Microbiology Chapters
Jul 2019
Effectively Addressing and Remediating FDA`s Form 483 Findings, Warning Letters and Consent Decree Compliance Issues
Jun 2019
Biocompatibility Testing for Medical Devices
Jun 2019
How to Prepare a Standard Operating Procedure (SOP)?
May 2019
New Elemental Impurities Tests for Pharmaceutical Products According to the New ICH Q3D and USP 232/233 Guidelines
May 2019
Latin America – Understanding Regulatory Compliance Requirements Across the Life Science Industry
May 2019
FDA Recalls - Before You Start, and After You Finish
May 2019
Stability Studies & Estimating Shelf Life
May 2019
ISO 14971:2012 - Does your current Risk Analysis still comply with your CE Mark requirements
Apr 2019
Method Development and Validation for Assays Supporting Testing of Biologics
Mar 2019
QbD Approach to Analytical Method Lifecycle: Design, Development, Validation and Transfer
Mar 2019
How to Implement a Quality Management System According ISO 13485?
Mar 2019
Medical Device Single Audit Program (MDSAP) - How to implement MDSAP in an existing Quality Management System (QMS)? Medical Device Single Audit Program (MDSAP)
Mar 2019
Selection and Use of (Certified) Reference Material in Analytical Laboratories
Mar 2019
The Most Serious FDA 483s - How to Avoid Them
Mar 2019
Statistics for Quality Engineering
Feb 2019
An Advanced Course on Lean Documents, Lean Configuration and Document Control
Feb 2019
Validation and Use of Excel Spreadsheets in FDA Regulated Environments
Feb 2019
Successful Water System Sanitization
Feb 2019
Understanding FDA Design Verification and Validation Requirements for Medical Devices
Feb 2019
Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan
Feb 2019
China & Pacific Rim Markets: Compliance Processes for Life Science Products - Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations
Jan 2019
Groundwater Discharge Monitoring Reports (DMRs) - Introduction and Overview
Jan 2019
Controlled Document System for a Life Sciences Manufacturing Plant - Principles of Lean Documents and Lean Configuration
Jan 2019
Medical Marijuana in the Workplace
Jan 2019
Verification vs. Validation in Regulated Industries
Jan 2019
Particulates in Biological Products - Evolving Regulations for Testing in Clinical and Commercial Stages
Dec 2018
Is your Medical Device Software 510(k) Ready?
Dec 2018
Conducting Effective Investigations of Out of Specification and Atypical Laboratory Results
Dec 2018
Meet the Tougher U.S. FDA CGMPs
Nov 2018
Auditing and examining Travel and Entertainment Expenses: Expense Reimbursement Fraud
Oct 2018
Troubleshooting Ethylene Oxide (EO) Processes
Oct 2018
Powerful Closed-loop CAPA - Meeting FDA Expectations
Oct 2018
Unraveling the Teaching Physician (PATH) Guidelines
Sep 2018
Manufacturing and Marketing OTC Drugs in Compliance with FDA Regulations (Updated to address recent Homeopathic Drug announcements by FDA & FTC)
Aug 2018
Effective Project Audit Implementation: Quality, Cost, Procurement Management
Aug 2018
Agile HR 101: Applying Agile to Human Resources
Aug 2018
Microsoft Excel - Let`s Look Beyond the Look-Up
Aug 2018
ACH 101 for Originators: ACH Rules
Jul 2018
Laboratory Investigations for Out of Specification Results
Jul 2018
Opioid Abuse in the Workplace: Using Effective Drug Testing and Policies to Reduce the Pain of the Painkiller Epidemic
Jul 2018
Developing a Contractor Safety Program
Jul 2018
Sunshine Act Reporting: Clarification for Clinical Research
Jul 2018
Good Documentation Guideline (Chapter <1029> USP)
Jul 2018
Root Cause Analysis (RCA) in the Laboratory - Addressing Non-Conformances
Jul 2018
Forced Degradation Studies/ Biologics Stability Programs for Biopharmaceuticals
Jul 2018
Sensitively Navigating Gender-Identity Issues in the California Workplace
Jul 2018
Deviation Investigation Best Practices: Ensuring Correct Content and Conclusions
Jul 2018
Patients Suing Under HIPAA
Jul 2018
Develop a Compliant Validation Protocol and Analytical Procedures according to the FDA Guidance and USP Good Documentation Practices
Jul 2018
Product Information for Medicinal Products in the EU
Jun 2018
Ligature Risks: Ensuring Compliance with the CMS Hospital CoPs and TJC Requirements
Jun 2018
510(k) Documentation Best Practices for Software or Software Enabled Medical Devices
Jun 2018
Biocompatibility Testing; what you need to know
Jun 2018
Water System Investigation `How-To`s` and Example Case Studies
Jun 2018
Current Regulatory Requirements for Sterile Products
May 2018
Does your QC lab do GMP and non-GMP activities?
May 2018
Why and How - Verification of Compendial Methods - USP [1226]
May 2018
Gaining and Re-Establishing Control of Your Cleanroom
May 2018
How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation
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
Design History Files, Device Master Records and Quality Management System for Medical Device Company - Principles of Lean Documents and Lean Configuration
Dec 2017
GMP Compliance for Quality Control and Contract Laboratories
Nov 2017
Navigating the Maze for Post-Market Compliance -- Complaint Handling, MDRs, Recalls and Proposed Guidance on FDA Risk Benefits
Oct 2017
The Regulations of OTC Drugs
Oct 2017
Lifecycle Approach to Analytical Methods for Drug Products: Incorporating QbD Concepts into Method Development, Validation, Verification and Transfer
Oct 2017
Computer System Validation - Reduce Costs and Avoid 483s
Oct 2017
FDA Scrutiny of Promotion and Advertising Practices
Sep 2017
21 CFR (Codigo de Regulamentos Federais) Parte 11 conformidade para a validacao de software e SaaS (Software como Servico)/Cloud
Sep 2017
Systematic Operating Procedures (SOPs) - What’s Really Required
Sep 2017
How to prepare a 510(k) Notification and a Technical File for the CE Mark
Aug 2017
How to Write Error Free Procedures and Instructions
Oct 2016
Supplier and Contractor Qualification and Control:
Oct 2016
Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)
Oct 2016
Meeting ILAC Requirements for Measurement Traceability to the SI through NIST and other National Metrology Institutes
Oct 2016
Data Integrity: FDA/EU Requirements and Implementation
Oct 2016
Analytical Methods in Development and Manufacture of Drugs and Biologics
Oct 2016
FDA`s Regulation of Implantable and Wearable Sensors
Oct 2016
Pharma Summit – Risk Control & Compliance
Oct 2016
How to Perform a Cognitive Load Assessment for Human Error Reduction
Sep 2016
Regulatory Requirements and Principles for Cleaning Validation
Sep 2016
The Benefit/Risk Ratio: Pharmacovigilance, Medical And Regulatory Converge
Sep 2016
Common Compliance Issues in a Quality Control Laboratory - Data Integrity, Out of Specifications (OOS), Corrective and Preventive Actions (CAPA)
Aug 2016
Analytical Methods in Development and Manufacture of Drugs and Biologics
Aug 2016
How FDA Trains Its Investigators to Review Sub-Systems for State of Compliance: What You Need to Do to Prepare for a Successful Inspection
Aug 2016
Understanding the Statistical Considerations for Quantitative ICH Guidelines
Aug 2016
Building a Vendor Qualification Program for FDA Regulated Industries
Aug 2016
Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)
Aug 2016
FDA Compliance and Clinical Trial Computer System Validation
Aug 2016
Data Integrity: FDA, WHO and EMA`s Requirements
Aug 2016
Navigating through Maze of In-vitro Diagnostics (IVD) Regulations: A systematic approach from Regulatory Strategy to Regulatory Approvals in U.S./Europe/Canada
Jul 2016
Designing a Supplier Qualification Program
Jul 2016
FDA`s Regulation of Regenerative Medicine including Stem Cell Treatments, Tissue Engineering and Gene Therapies
Jul 2016
Developing Documents and Records to meet ISO 17025 Requirements
Jul 2016
Best Practices for Safety Reporting in Clinical Trials for Drugs, Biologics and Medical Devices
Jun 2016
Design of Experiments for Process and Product optimization
Jun 2016
Global Regulations for Equipment Qualification and Validation of Processes in the Pharma Manufacturing
Jun 2016
Overview of clinical drug development from final preclinical selection, marketing approval, all phases of clinical trials, new strategies, challenges and solutions
May 2016
Integration of Human Factors into Medical Device Design: FDA and European Commission
Apr 2016
FDA Import, Export and Foreign Operations for Medical Devices and Pharmaceuticals
Apr 2016
Project management tools to improve productivity and compliance in Analytical laboratories
Feb 2016
Managing FDA Inspections from Readiness through Follow Up Responses
Jan 2016
Compliant Clinical Research Conduct: What Every Clinical Research Professional Needs to Know
Jan 2016
Process Robustness: The New FDA Paradigm
Jan 2016
Safe Drinking Water - Another Oxymoron?
Dec 2015
Objectionable Microorganisms: Considering the Risk
Dec 2015
Regulatory Crisis Management: Best Practices for Dealing with the Common Crisis Events for the FDA-Regulated Industry
Nov 2015
Building a Vendor Qualification Program for FDA Regulated Industries
Nov 2015
How to Prepare for, Manage, and Follow-up to an FDA Inspection: Risk-driven Approach
Oct 2015
Product Stability Testing Program - Designing and Sustaining New and Existing Programs
Oct 2015
How to Survive a DEA Inspection Series: Controlled Substances and Hospital Pharmacy
Oct 2015
Is your Essential Requirements Checklist (ERC) up to snuff?
Oct 2015
Best Strategies for Meeting US (IND through Post Marketing) Drug Safety Requirements Efficiently
Oct 2015
Clinical Research Project management for Life science industry
Oct 2015
GMP Validation Workshop | Learn to create your own workshop and private sessions
Oct 2015
Veterinary Drug Approvals: Practical Considerations for Conducting FDA-Required Regulated Studies
Oct 2015
Developing an Environmental Monitoring Strategy for a Non-Sterile and Aseptic Processing Area (Controlled/Classified Environment) -- To Include HVAC and Utility Systems
Oct 2015
Laboratory Inspections – Be Prepared, Be Validated and Avoid Observations
Oct 2015
How to Buy COTS Software, and Audit and Validate Vendors
Oct 2015
An Easy to Implement Integrated Risk Management Approach Compliant with ISO 14971
Sep 2015
OSHA 10 Hour Course
Sep 2015
How to Prepare for an FDA Meeting: Making the Most of Pre-IND/IDE, pre-NDA and Other Critical Meetings
Sep 2015
Hazardous Waste Regulation: 10 Major Differences Between Federal RCRA and California Hazardous Waste Regulations
Sep 2015
Budgeting for Clinical Trials: Understanding Costs of a Study and Which Costs Sponsors are Responsible to Cover
Sep 2015
How to Transition from Paper to Electronic Records in a Regulatory Environment
Sep 2015
What to Expect in a Federal HIPAA Audit & How to Avoid Audit
Sep 2015
CAPA Investigations - Tools for a Compliant and Effective Investigation Process
Sep 2015
Getting to Know FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies
Aug 2015
Key Considerations in Verification & Validation of Medical Devices
Aug 2015
Creating a Global Regulatory Plan
Aug 2015
Understanding FDA Regulations and Role in Opioid Pain Management
Aug 2015
Understanding the Mobile Medical Applications Guidance
Aug 2015
USP Hot Topics: What`s Hot Now and How to Track Coming Changes and Influence USP
Jul 2015
The Future of OTC Drug Regulation and the Monograph Process
Jul 2015
Navigating the New FDA Draft Guidance on ISO 10993: Biological Evaluation of Medical Devices
Jul 2015
Conducting Audits in Non-English Locales - How to Ensure that Best Practices are Followed
Jul 2015
Technical and Regulatory Writing for FDA Regulated Industries
Jul 2015
Compliance Processes for Life Science Products in Brazil, Russia, India, China markets - Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations
Jul 2015
Preparing for the LDT Regulation
Jul 2015
Using Q-Submission to Most Effectively Prepare for an FDA 510(k) Submission
Jul 2015
The European Clinical Trial Directive…Plus…European Filings and Registration Procedures
Jun 2015
Monitoring Plans: 10 Rules of Effective Writing of Monitoring Plans
May 2015
Optimal Resource Allocation and Capacity Planning for Biopharma and CRO
May 2015
CAPA, Failure Investigation and Root Cause Analysis - FDA Expectations
May 2015
Writing Effective Journal Abstracts: A Guide for Medical Writers and Clinical Research Professionals
May 2015
UDI Implementation
Apr 2015
Electronic Records and Signatures - 21 CFR Part 11: Basic Concepts
Apr 2015
Is it Method Verification or Validation, or Just Semantics?
Apr 2015
Combination Drug/Device Products CGMPs - Final Rule
Apr 2015
China: Compliance Processes for Life Science Products (Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations)
Apr 2015
Health Canada’s Enforcement of the Regulatory Requirements for the Manufacture, Advertising and Sale of Pharmaceuticals, Medical Devices and Natural Health Products
Mar 2015
New Part 11 Guidance for Clinical Trials: What This Means for You
Mar 2015
Designing Effective and Efficient Extractables or Leachables Studies for Biologics
Mar 2015
Superiority, Non-inferiority, or Equivalence Trials: How, Why and When
Mar 2015
Good Laboratory Practices for Food Manufacturing
Mar 2015
Application of Disinfectants and Sterilants to Control Microorganisms; FDA Endotoxin Test – Understanding the Latest Revision
Mar 2015
Deconstructing Warning Letters - Using Warning Letters to Illustrate the FDA and Health Canada CFRs
Mar 2015
Institutional Review Boards (IRBs): The Changing Landscape and the Effect on the Conduct of Clinical Research
Mar 2015
How to Avoid an FDA Warning Letter with a Strong CAPA Program
Mar 2015
Key GMP Systems in Pharmaceutical and Biotech Labs
Feb 2015
Stability Program to Support Shipping and Distribution of Drug Products
Feb 2015
Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing
Feb 2015
Blinding of Investigational Materials
Feb 2015
Changing Supplier Controls Requirements
Feb 2015
A Bulletproof, Cost-efficient Supplier Management Program
Jan 2015
New Requirements for Sponsors and Laboratories for Analyzing Clinical Trial Samples to Meet GCP/GCLP Internationally
Jan 2015
21 CFR Part 11 and Annex 11 Compliance - specifics needed to eliminate 483s
Jan 2015
EU Clinical Trial Regulation: New Requirements
Jan 2015
GAMP 5 as applied to FDA software validation - strategies to avoid warning letters
Jan 2015
Conducting Effective Investigation of Out-of-Specs and Atypical Laboratory Data
Jul 2014
Effective Contamination Control in Biopharmaceutical Manufacturing
Jul 2014
Developing Biosimilars in Emerging Markets: Regulatory and Clinical Considerations
Jul 2014
Remediating Pharmaceutical Water System Biofilm - What to Do After It Gets Ahead of You
Nov 2013
Social Media and Marketing FDA Regulated Products
Nov 2013
Corrective and Preventive Actions(CAPA) - 8 Steps to Achieve Compliance
Nov 2013
Study to Support Shipping and Distributing Pharmaceutical Products
Oct 2013
CLIA (Clinical Laboratory Improvement Amendments) Guidelines on Quality Control and Quality Assessment
Oct 2013
3-hr Virtual Seminar: US, EU and Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus
Oct 2013
Premarket Review of New and Modified Tobacco Products
Oct 2013
Verification of Compendial Methods According to the Revised USP Chapter <1226>
Oct 2013
Water System Mythology: Common False Beliefs for Microbial Control and Monitoring
Oct 2013
Effective CAPAs: How to Avoid Scrutiny in FDA’s Latest Area of Focus
Sep 2013
FDA`s Oversight of Mobile Medical Applications (`apps`) for Use on Smartphones and Similar Mobile Devices
Sep 2013
FDA Requirements for Device Labeling: Development, Contents, Distribution, and Changes
Aug 2013
Developing and Updating a ``Compliant`` Lab Compliance Plan (Medicare and Medicaid Focus)
Aug 2013
Using Statistical Methods for ICH Guidelines
Aug 2013
Coping with a Difficult Compliance Officer when Responding to a 483, Warning Letter, Import Alert or Recall
Aug 2013
Regulatory Differences Between Biopharmaceutics and Medical Devices
Aug 2013
FDA and Social Media - How to Promote your Products Using Web 2.0 in Compliance with FDA and FTC Laws and Regulations
Jun 2013
Introduction to Bioequivalence and Therapeutic Equivalence
Jun 2013
FDA Warning Letter Closeout Program
May 2013
Conducting Successful FDA Meetings to Negotiate Product Development and Approval: 2-day In-person Seminar
Apr 2013
OSHA Process Safety Management (PSM) Compliance Directive (CPL) and Interpretations
Apr 2013
Statistics for GMP Auditors
Apr 2013
How to Make GMP Training Fun and Engaging
Apr 2013
How to Withstand an FDA Audit of your Facility
Apr 2013
Auditing the QC Microbiology Laboratory for FDA Compliance
Apr 2013
When is Corrective Action Not Enough - Doing and Documenting Corrections is an ISO 13485 Expectation
Apr 2013
3-hr Virtual Seminar: Annual ICH GCP Refresher Course
Apr 2013
Designing a Clinical Protocol for Vaccine Clinical Trial
Apr 2013
Bioanalytical Methods Validation
Mar 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
Writing Clinical Data Queries - Best Practices and Pitfalls
Mar 2013
Clinical Laboratory Incident Management Plan - GLP and FDA Compliance
Feb 2013
Defining Computer System Validation & Software Development Life-Cycle
Feb 2013
Adaptive Clinical Trials - Clinical Trials Version 2.0
Feb 2013
Effectiveness Measures in CAPA and Risk Management Plans: Applying LSS for Quality Metrics
Feb 2013
Social Media: Using The Legal Guideposts to Create Social Media Success (for Healthcare/Lifescience Companies)
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
Basic Cell Culture & Fermentation - Process Development & Manufacture
Jan 2013
Objectionable Microorganisms in Medicinal Products - Aseptic Environment
Jan 2013
Decoding CLIA (Clinical Laboratory Improvement Amendments) Regulations
Jan 2013
Negotiating Clinical Trial Contracts in a Minefield: The Stark Rule, Anti-kickback Statute (AKS), False Claims Act (FCA) and Medicare Secondary Payer Rule (MSPR)
Jan 2013
Quality Assurance at the (Clinical Research) Site: How to Develop a Manageable Plan
Dec 2012
Practical strategies to Improve Productivity in the Pharmaceutical Laboratory
Nov 2012
Contamination-Control and Cleaning and Disinfection
Nov 2012
Efficient, Effective and Compliant Documentation in the QC Laboratory
Nov 2012
System Based Inspections - Laboratory Controls
Oct 2012
Risk Assessment-Compliance Using Easy To Fill Out Documentation
Sep 2012
How to Select Best Practices a CRO ?
Sep 2012
Investigator Initiated (Sponsored) Trials – ISSs
Sep 2012
Strategies for Preparing and Submitting Successful Citizen Petitions and Suitability Petitions to FDA
Aug 2012
Site Challenges in Conducting Investigational Device Trials
Aug 2012
Addressing Impurities in Pharmaceutical Products: Impurities, Degradants, Residual Solvents and Elemental Impurities
Aug 2012
New QC Based on Risk Management: A Collaboration between CLIA and CLSI
Jul 2012
Strategic Selection and Development of Immunogenicity Binding Methods
Jul 2012
Ethics and Scientific Misconduct in Regulated Studies
Jul 2012
Software validation and 21 CFR Part 11 remediation planning: FDA inspection strategies
Jul 2012
Chemical Safety and Chemical Hygiene Plans for the Lab Environment
Jul 2012
Specialized Formulations – Biomolecules
Jul 2012
HPLC Outside the Box: How to Think Like a Chromatographer
Jul 2012
HPLC Outside the Box: Beating Your Competitors to Market
Jul 2012
What Every FDA Regulated Company Needs to Know About its FDA District Office
Jul 2012
Project Management for Auditors – Improving audit productivity for GCP, GMP and GLP
Jul 2012
Clinical Trial Auditing - Identifying risks and building a more compliant and successful trial
Jul 2012
Managing GLP Studies in Non-GLP Facilities - Webinar By ComplianceOnline
Jul 2012
Obtaining and Marketing Your 510(k) with Today`s FDA, a 510(k) Workshop
Jun 2012
Recommendations for Cell Banks used in GXP testing - Webinar By ComplianceOnline
Jun 2012
Good Laboratory Practices for Bioanalytical Laboratories - Webinar By ComplianceOnline
Jun 2012
Understanding and Implementing ISO 17025
Jun 2012
Test Article Management and Characterization for Drugs and Devices - Webinar By ComplianceOnline
Jun 2012
Navigating the Japan and South Korean Regulatory Compliance and Clinical Trial Environment
Jun 2012
Making Sense of FDA’s (proposed) Rules for the Development and Approval of Biosimilars
May 2012
The A to Z’s of Microbial Control, Monitoring and validation of Pharmaceutical Water Systems
May 2012
Supplier Controls to Meet Tougher U.S. FDA Requirements
May 2012
How to Format Succinct and Comprehensive 510(k)s and PMAs
Apr 2012
The Hero of Manufacturing Contamination Control - The Microbiology Lab
Apr 2012
Good Laboratory Practice (GLP) for Non-Clinical Laboratory Studies - Application and Compliance to Ensure Safety of Biologic Therapeutics and Medical Devices
Apr 2012
Life Cycle Validation of GMP Potency Bioassays
Apr 2012
Good Documentation Practices for GXPs
Apr 2012
Project Management To Meet CGMP Requirements
Mar 2012
Doing Business Despite Embargoes and Sanctions: OFAC Licensing
Mar 2012
Validation of Bioanalytical Methods and Procedures for FDA Compliance
Mar 2012
Managing Immunogenicity Risk in Biopharmaceuticals
Mar 2012
Method Validation in Drug Development Process - Common Mistakes and Issues
Mar 2012
Software Verification and Validation Planning and Implementation
Mar 2012
Validation of Analytical Procedures for Use in the Pharmaceutical Industry
Feb 2012
Leaping into Lab: Everything about Waived Testing
Feb 2012
Design History Files, Device Master Records, Device History Records, and Technical Files / Design Dossiers -- Differences and Similarities
Feb 2012
Does your pharmaceutical lab have GMP and non-GMP functions?
Feb 2012
How to prepare for and survive a CLIA inspection - Clinical Laboratories Improvement Act
Feb 2012
Introduction to the Electronic Common Technical Document
Jan 2012
Validation and use of Access Databases in FDA regulated environments
Jan 2012
Troubleshooting Microbial Excursions in Pharmaceutical and Biotech Operations
Jan 2012
Purposeful Water and Steam System Validation – Not Just A Regulatory Requirement
Jan 2012
FDA’s New Food Safety Law - What does It mean for everyone in the Global Food Chain
Jan 2012
Proven Root Cause Investigation Techniques for Pharmaceutical Water Systems
Dec 2011
How to Identify Hazardous Wastes at the Work Place - Webinar By ComplianceOnline
Sep 2011
Investigator responsibilities and Legal commitments in Drug and Device Clinical Research
Sep 2011
A Rational Approach to Developing and Troubleshooting Dissolution Methods for a Variety of Purposes
Sep 2011
Eliminate the Confusion – Physician Quality Reporting System for Anesthesia Claims
Sep 2011
Why Nobody Believes the Numbers: The Secrets of Care Management Outcomes Measurement Revealed
Sep 2011
Common GCP Violations and Site Mistakes - How to Avoid them
Aug 2011
How Due Diligence in Accurate Adverse Event Reporting is the Key to a clean FDA Audit
Aug 2011
Clinical Project Management - Webinar By ComplianceOnline
Aug 2011
Review and Implementation of USP <1058> Analytical Instrument Qualification
Aug 2011
Vendor Qualification - Designing and Implementing an Efficient and Compliant Vendor Program
Aug 2011
Trial Master File for Research Sites: Can You Pass FDA Inspection?
Aug 2011
Auditing the QC Microbiology Laboratory for FDA Compliance - Webinar By ComplianceOnline
Aug 2011
Bioanalytical Methods Validation - Webinar By ComplianceOnline
Aug 2011
Analytical Test Methods Validation: FDA, ICH and USP Requirements - Webinar By ComplianceOnline
Aug 2011
How to manage an EPA inspection - Webinar By ComplianceOnline
Jul 2011
Vendor Qualification Auditing for FDA Computer System Compliance - Webinar By ComplianceOnline
Jul 2011
Clinical Document Management and Collaborative Electronic Data Exchange in Clinical Trials
Jul 2011
How to Avoid the Environmental Compliance Nightmare - Webinar By ComplianceOnline
Jul 2011
Using the USP Effectively - Webinar By ComplianceOnline
Jul 2011
Key Concepts in OSHA Recordkeeping – 2.5 hrs comprehensive webinar
Jul 2011
Eliminate the Confusion - Compliance for Anesthesia Services
Jul 2011
Navigating the new FDA world of Combination Products
Jun 2011
Lyophilization Process Development and Cycle Design
May 2011
`The Right Stuff` – Implementing Quality Control Tools in Quality Systems Operations
May 2011
ComplianceOnline Virtual Seminar - Controlling Outsourcing Using Quality Principles - For Lifesciences Companies
May 2011
Retirement of Computer Systems: Strategies for FDA Compliance and Tools for Implementation
May 2011
Proficiency Testing: How to Pass with Flying Colors and What to Do If You Don`t
Apr 2011
Designing appropriate product specifications for lyophilized parenteral products
Apr 2011
Eliminate the Confusion - New Requirements for Clinical Laboratories to Meet GCP
Apr 2011
ComplianceOnline Webinar - Why and How - Verification of Compendial Methods - USP [1226]
Apr 2011
Decoding CLIA Regulations: Calibration, Calibration Verification and Method Validation
Apr 2011
Recent Major Industry CGMP Failures
Apr 2011
Presenting the real GCP handbook: Build solid knowledge of GCP by learning the rules exactly as they appear in the official text
Mar 2011
2-day In-person Seminar - Electronic Records: Effective Approaches that Reduce Costs
Mar 2011
A Comparison of ICH Q-10 Quality System and the FDA’s Quality Systems Approach (QSA) to the Pharmaceutical cGMPs
Mar 2011
How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant?
Mar 2011
Differences between ICH-GCP and FDA regulations
Mar 2011
Why You Need to Integrate Your Wellness Program with Your EHS Program
Mar 2011
Design Control Explained - Medical Device Webinar
Mar 2011
Alternative Food Preservation: Pasteurization - Part 2
Mar 2011
Integrating a Quality Management System and Risk Management for Medical Devices Dallas
Mar 2011
Responsibilities of a Clinical Research Coordinator managing clinical trial/s under the supervision of a Principal Investigator
Mar 2011
How to prepare for Increased OSHA penalties in
Feb 2011
Integrating a Quality Management System and Risk Management for Medical Devices
Feb 2011
How to reduce EO residuals in medical devices
Feb 2011
Last changes in Canadian ethics regulations for clinical trial
Feb 2011
Implementation of Rapid Microbiological Methods
Feb 2011
How to secure GCP compliance in Clinical Trials: The complete overview of the critical parameters 2010
Feb 2011
Software Verification and Validation Planning and Execution
Feb 2011
Techniques of Hazard Recognition
Feb 2011
Eliminate the Confusion –Annex 13 GMP guide
Feb 2011
Responsibilities of a Principal Investigator in Clinical Trials: What you Must Do to Ensure Trial Compliance
Feb 2011
21 CFR Part 212: Quality Systems to Ensure cGMP Compliance
Feb 2011
Risk-Based Verification and Validation Planning to Meet U.S. FDA, ICH Q9 and ISO 14971
Feb 2011
Understanding and Implementing FDA’S 21 CFR Part 11
Feb 2011
Compliance with The European Medicines Agency reflection paper on e-source data
Feb 2011
Ethics, Standards and Identifying Risks in Clinical Research - ComplianceOnline Clinical Training
Jan 2011
Assessing FDA’s Proposed Changes to the 510(k) Process in
Jan 2011
cGMP: Strategies for implementation and compliance for Phase I Investigational Drug and Biologic products
Jan 2011
The CLIA Laboratory Inspection: Failure is not an Option - ComplianceOnline Laboratory Webinar 2010
Jan 2011
Clear as Mud: Obtaining and Marketing Your 510(k) With Today`s FDA San Francisco
Jan 2011
How to Vet an IRB: Expose and Fix Problems Before They Threaten Your Trial
Jan 2011
An Easy to Implement Integrated Risk Management Approach Compliant with ISO 14971
Jan 2011
How to Set up Data Monitoring Committees (DMCs / DSMBs) and what is effect on the Drug Development Process - ComplianceOnline Clinical Training
Dec 2010
Assessing GCP Compliance in Clinical Trial Audits- Risk management and Best practices - ComplianceOnline Clinical Training
Dec 2010
QSR Device Inspections – Transition from “Barely Surviving” to “Gaining Control”
Nov 2010
Conducting Clinical Trials in Latin America: keys to successful study implementation
Nov 2010
Laboratory Investigations Relating to Sample Re-Analysis: Covering the basics before being called out - ComplianceOnline Laboratory Webinar
Nov 2010
Best Practices of Recruiting Subjects in Conducting Clinical Trials: What does it take to be successful - ComplianceOnline Clinical Training
Nov 2010
Performing Investigations for Environmental Excursions - ComplianceOnline Biotechnology Training
Nov 2010
How to Use Foreign Trial Data in Your NDA Approval Process
Nov 2010
Are you a new Clinical Research Coordinator? Tips on how to get started, what to expect
Nov 2010
Clinical Trial Regulations and GCP Compliance as they relate to Adverse Events - How to Assess and report AEs and SAEs
Oct 2010
Quality System Regulation (QSR) Management Responsibilities
Oct 2010
Navigating Pediatric Trials from recruitment to successful on-time completion
Oct 2010
ComplianceOnline Webinar - Gamma Sterilizer Validation: Method 1 and VDmax25 per ISO 11137 ()
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
Data Monitoring Committees (DMCs) effect on subject safety in clinical research and how to set it up to be effective
Oct 2010
The FDA Tripod - Clinical Trial Regulations, Compliance and GCP in Drug Development
Oct 2010
ComplianceOnline Webinar - GMPs in Biopharmaceutical Development Laboratories
Oct 2010
What to Expect in a Food Safety Audit
Sep 2010
Ensuring GCP compliance through quality auditing in clinical trial
Sep 2010
Effective Quality Process Improvement for Medical Device Firms: Don’t get caught managing process through standardized SOP’s
Sep 2010
The ICF Process: Tips on Achieving Optimal compliance and Comprehension
Sep 2010
EU IMPD vs. US IND: Comparing the Content and Agency Expectations
Sep 2010
What are the “Good Clinical Practices” (GCP) of Research involving Human Subjects
Sep 2010
ComplianceOnline Webinar - Medical Device Changes and The 510(k)
Sep 2010
Developing Supplier Quality Auditor Training Programs
Sep 2010
The role of Analytical Program to Support Drug Development Process
Sep 2010
Key Factors to Write an Effective Standard Operating Procedure (SOP)
Sep 2010
Engineering and Laboratory Mythology with Water System
Sep 2010
ComplianceOnline Webinar - Streamline Documentation System in Pharmaceutical Laboratory
Aug 2010
System Based Inspections - The Laboratory Control System
Aug 2010

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