Description

Overview: 21 CFR Part 11 is FDA regulation for electronic signatures and electronic records. It started by the Pharma - it is a good regulation for medical and Pharma companies but it is also a good guideline for other industries.

Why Should You Attend: FDA inspectors are ever increasing the number of inspections where they include Part 11 as a part of the scope or THE scope of the inspection. The trends and reports are showing that the FDA inspectors are focusing on electronic signatures and electronic records as more and more companies are implementing systems and technologies to support these activities. The number of warning letters is increasing proportionally and we as quality and other professionals utilizing the technology and systems to support our businesses are not ready - we are not ready to prepare and host FDA inspections when Part 11 is in scope, we are unsure how to best use and implement Audit Trails and certainly we have challenges with internal and external auditing for Part 11 compliance. This webinar will address all these topics and provides you with plenty HOW TO we as auditors and inspectors increase our comfort level with the regulation, with its elements and compliance and practically implement audit system and audit trails - especially since Audit Trails play major role in Part 11 compliance - they can be your best friends and/or worst enemies at the same time.

Areas Covered in the Seminar:

Module 1 - Overview and Understanding of the Regulation

Introduction and development of the regulation
What to expect in the future when it comes to the regulation
Options for (non)compliance
`What ifs`
Most impactful sections and subsections of the regulations

Module 2 - How to Prepare and Host FDA Inspections

Elements and details of preparation for the inspection
Elements of the successful practices of hosting an FDA inspection when Part 11 is in scope or the scope of the inspection
Some commonly asked questions by the inspectors and benefits of being compliant

Module 3 - Internal and External Auditing for Part 11 Compliance

Aspects of auditing for Part 11 compliance- starting at the audit program level and then going down on how to prepare for an audit to how to successfully execute the audit and follow up on the completed audit
CAPA and responses for the audit findings related to Part 11 - what to expect and handle the difference between `regular` audits and Part 11 audits
Some of the common audit findings and common pitfalls as well as tools for a successful planning and execution of the audit

Module 4 - Audit Trails

Types of audit trails
Strategies for implementing complaint audit trails
Pros and cons of audit trails
How to use audit trails as an audit tool during the internal and external audit as well as during the FDA inspection visit
Some examples of `shoulds` and `shouldn`ts` when it comes to the audit trails
Commonly asked questions related to audit trails

NOTE: Throughout the webinar, as a part of the modules above, we will include:

Trends
Warning Letter Examples
Advantages and Challenges of the Regulation
Where Part 11 regulations impacts you the most
Show examples of the warning letters that have been issued in last several years due to lack of compliance with the Part 11 regulation
Importance and significance of the regulation regardless if it (currently) applies to you or not
Examples and HOW TO so that you and your team can get most out of the materials and presentation - and to be able to use it immediately after attending this training/webinar

Who Will Benefit: