Jasmin NUHIC
Instructor Jasmin NUHIC
Product Id 600386
Duration 4 Hours
Version Recorded
Original Price $295
Special Offer Price $10
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

21 CFR Part 11: Complete Manual For Compliance Success - GlobalCompliancePanel Virtual Seminar


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:
  • Quality Managers
  • Quality Engineers
  • Small business owners
  • CAPA investigators
  • Inspectors
  • Six Sigma specialists
  • Consultants

Speaker Profile
Jasmin NUHIC serves a major medical devices OEM as a Sr. Compliance Quality Engineer and 21 CFR Part 11 Subject Matter Expert. He also served ASQ section as a chair for two consecutive terms, has taught quality certification exam prep course, completed numerous software validations and obtained over 25 different certifications in leadership, quality, software validations, and more. Jasmin NUHIC has conducted Webinars on this and other topics with high attendance and appreciation.

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