Compliance Trainings

21 CFR Part 11 and Risk Assessment 2019


This 2-day Seminar on 21 CFR Part 11 and Risk Assessment will help you get completely familiar with the FDA – compliant implementation of 21 CFR Part 11 requirements applicable to the regulated industry. Today, the FDA performs both GxP and Part 11 inspections, with an updated Annex 11 regulation that expands Part 11 requirements, and companies must update their systems and processes to maintain compliance.

Event Type:
Workshops/Training Courses
Jul. 25, 2019
Ahmedabad, GJ , India

You will get a full understanding of how to perform Risk Assessment as part of the step-by-step risk-based approach to computer system validation. This distinct approach will help minimize project time. You can ensure compliance with QA, FDA, and clients.

Majority of inspection reports such as 483’s and Warning Letters quote issues with 21 CFR Part 11 and data integrity as deviations from GxP regulations. Only way to control and avoid warning letters is by receiving effective Training. Mr. Kalpesh Vaghela’s extensive years of experience in the field of third party audit can help your team to better understand & could help reduce your vulnerability of getting 483’s and warning letters, by great amount.

Our instructor will use examples and real life case studies to better illustrate the application of the techniques for any validation project. Using recent warning letters as examples, this seminar will demonstrate how current Part 11 requirements will be met. With effective implementation of learnings from this seminar, you can avoid warning letters, reduce costs, improve quality, increase compliance with less documentation.

Areas Covered in the Seminar:

  • 21 CFR Part 11 Compliance
  • Key Requirements of Part 11
  • Annex 11
  • Learning from Recent Warning Letters
  • Computer System Validation
  • Achieving Data Integrity
  • Meeting Data Integrity Regulations
  • VMP & Design Specifications
  • Risk Assessment
  • Risk Based Validation
  • SOPs and Best Practices
  • CASE STUDIES ….and More

  • Quality Assurance Management and Personnel
  • Regulatory Affairs Management and Personnel
  • Research & Development Management and Personnel
  • Operations Management and Personnel
  • Production Management and Personnel
  • Manufacturing Management and Personnel
  • Engineering Management and Personnel
  • Facility and Maintenance Management and Personnel
  • Everyone involved in Product, Process, CAPA Resolution, Failure Investigation Responsibilities

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