Webinar ID:   ICT105

3-Hour Virtual Seminar on 21 CFR Part 11, e-CFR Part 11 and EU GMP Annex 11

  3 Hours

Categories:   Uncategorised,

Many peoples speak about 21 CFR part 11 compliance. But need to understand more about the contents of e-CFR. The Electronic Code of Federal Regulations (e-CFR) is a web version of the Code of Federal Regulations (CFR) that FDA update daily to better reflect its current status. The e-CFR is an editorial compilation of CFR material and amendments published in the daily Federal Register.

As, it is required to understand the requirements for electronic records and electronic signatures, it is mandatory to understand requirements of 21 CFR Part 11, e-CFR & EU GMP Annex 11

Course Objective:

  • During webinar, we will make you aware about the e-CFR.
  • This webinar will make you understand the requirements of 21 CFR Part 11, e-CFR & EU GMP Annex 11 under one umbrella
  • The webinar will trigger the process of awareness about the current state/level of GMP compliance of the organizations.
  • These activities can safeguard the organizations from product failure to negative actions by the regulatory agencies.

Who Should Attend:

  • Quality Assurance Departments
  • Quality Control Departments
  • Research and Development Departments
  • Regulatory Affairs Departments
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Validation Departments
  • IT Departments
  • Documentation Departments
  • Supply Chain Departments
  • Auditors


HitendraKumar Shah

Hitendrakumar Shah is a renown Quality oriented professional with over 20 years of experience in Quality Assurance and Quality Control. During this period, he has been actively involved in process control, Finished product release, Investigations, product recalls and other quality notifications. He has helped numerous companies in ensuring CAPA implementation & effectiveness, Quality system review and reporting, Supplier audit, GMP training, risk assessment and validation activities.

His Key Competencies are but not limited to Quality Compliance, Vendor Audit, data integrity, Risk assessment, Qualification & validation, Review and finalization of technical agreements. He is the CEO of NADH+ GxP Compliance Services and a popular figure on social media for his effective and easily understandable training bites.

Section 1: Introduction and overview of seminar subject

Section 2: Purpose and scope of CSV
– Benefits of using computerized system

Section 3: EU GMP Annex 11
– Discussion about PIC/S annex and similarity
– Discussion on role of risk management
– Personnel
– Supplier and service providers
– Validation phases
– Keys in data storage
– Audit trail
– Security and business continuity etc.

Section 4: 21 CFR Part 11
– Discussion on guide for Part 11 compliance strategy
– Discussion on validation
– Audit trail
– Legacy systems
– Copies of records and record retention.
– Discussion and comparison of different guides for Part 11 compliance

Section 5: e-CFR concept
– How FDA functions and deal e-CFR and converted to CFR
– Evaluation of special requirements of e-CFR which are not part of CFR part 11 and EU GMP annex 11

Section 7: Discussion and Q&A Session