Course Overview:

Navigating the complexities of 21 CFR Part 11: Electronic Records and Electronic Signatures can be daunting for healthcare manufacturers. Established in 1997, this regulation has evolved into a crucial component for ensuring data integrity in regulated life sciences.

Our Interpreting 21 CFR Part 11 and Revised EU Annex 11 Training course is designed to clarify misconceptions and provide a complete understanding of these regulations.

In this one-day training course, participants will explore the relationship between 21 CFR Part 11 and the revised EU GMP Annex 11, including key insights from GMP Volume 4, Chapter 4 on Documentation.

As regulated life science companies increasingly rely on computerised systems, it's vital to equip staff with the knowledge to manage regulatory challenges effectively and implement compliant strategies.

Sign up to deepen your understanding of the requirements, learn about recent revisions, and gain insights into effective data integrity practices.

What You Will Learn:

• Understanding 21 CFR Part 11:
  Grasp the essentials of the regulation, its significance, and its requirements for compliance.

• Guidance vs. Regulation:
  Differentiate between regulatory guidance and requirements, focusing on key terminology.

• Document Lifecycle Management:
  Examine the lifecycle of electronic and hard-copy records, including scope, validation requirements, and predicate regulations.

• Risk Management in Record Keeping:
  Understand the 'Hybrid' approach to record risk management and its links to validation.

• Signature Controls and Management Responsibilities:
  Review signature uniqueness, biometrics, password controls, and the responsibilities of management in maintaining compliance.

• FDA Guidance and Recent Updates:
  Learn about the latest FDA assessments, common compliance issues, and case studies illustrating the application of Part 11.

• EU GMP Annex 11 Compliance:
  Analyse the revised guidance on computerised systems, focusing on record-keeping and signature management.

• GAMP® Compliance Approach:
  Discover the GAMP® methodology for achieving compliance with 21 CFR Part 11, including risk assessments and practical applications.

• Data Integrity Focus:
  Explore current regulatory challenges regarding data integrity and strategies for effective control measures.