Overview:

The American regulation 21 CFR Part 11: Electronic Records; Electronic Signatures has been one of the most significantly difficult regulations for healthcare manufacturers to understand and implement since its conception and authorisation in 1997.  The Interpreting the Regulation 21 CFR Part 11 and revised EU Annex 11 (1 Day) Training Course, seeks to demystify misconceptions and beliefs on what it means for companies.

The course also provides a review and comparison of Part 11 with Annex 11 and related EU GMP Volume 4 Chapter 4 on Documentation.

Regulated life science companies rely on the integrity of their data to ensure product quality. With increasing use of computerised systems in GMP operations regulatory authorities need to be assured that companies can manage the challenges that face them in understanding the complexities surrounding this subject and be confident that implemented strategies are effective.

So if you want to understand 21 CFR Part 11, what has been revised in the EU GMP Annex 11 and Chapter 4, and examine the GAMP®’s interpretation of the guidance, and the subject of data integrity then why not attend our course?

Content:

• Understand the regulation 21 CFR Part 11

  • What the requirements are

  • Why is the regulation necessary?

  • The difference between guidance and regulation

• Identify key terminology used in the regulation

  • Terms and definitions

• Lifecycle of a document

  • Electronic

  • Hard copy

  • Records

• What is in and out of scope?

  • Validation requirements for computer systems

  • Predicate regulations - what are they, where to look and why?

  • A focus on risk to records and the 'Hybrid' approach

• Links to validation

  • Validation requirements for computer systems

• Training

  • Requirements

  • Qualifications and experience

• Management of systems

  • For open and closed systems

  • Physical and logical controls

• Signatures

  • Signature/record linking

  • Their uniqueness

  • Biometrics

• Controls

  • Password ageing

  • Procedures

  • Management responsibilities

• Understand FDA Part 11 Guidance for Industry

  • Latest thinking and guidance

  • Why the FDA is now assessing whether companies are using its revised guidance

• Recall problems encountered by companies applying the rule

  • Potential problem areas

  • Case studies

  • Differing scenarios/FDA warning letter reviews

  • Comparison between how the FDA used to audit and report compliance issues and how it is now

• Identify and review EU GMP Annex 11 revised guidance on Computerised Systems focusing on records and signatures

  • Review includes:

    • Corresponding GMP Volume 4 Guide, revision of Chapter 4 Documentation

    • Updates from previous revision of Annex 11

    • Cross reference to Part 11

• Describe the GAMP® approach to 21 CFR Part 11 compliance

  • Links with GAMP® and risk assessment

  • Review examples from the guide

  • Use GAMP® risk assessment to assess a potential real scenario

• Explore the subject of data integrity and understand the reasons for the current regulatory focus including:

  • European and FDA regulatory guidance

  • Challenges to Data Integrity and effective strategies

  • Data Integrity control measures