Section- 1

INTRODUCTION

1. Pharmaceutical Industry & role of FDA
2. Jobs in Pharma Industry
3. What is 21 CFR Part 11 – An Overview
4. Predicate Rules cGMP/GCP/GLP Overview
5. Creating and Updating E-Records
6. Review of E-Records from P11 perspective
7. GxP assessment & Exercise
8. Define SDLC (Life Cycle Concepts) methodology

Section- 2

21 CFR PART 11

1. Part 11(Definitions & Terminology)
2. Gathering Requirements and Writing URS for an complaint Application
3. E-Signatures
4. Open System and closed system
5. Controls for Closed & Open Systems
6. Overview of SOP's
7. Overview of IQ/OQ/PQ

Section- 3

21 CFR PART 11

1. Creation of an SOP (IQ/OQ)
2. Gathering Requirements and Writing FRS
3. Write IQ/OQ Test Plan for an complaint Application
4. Overview of Validation / Verification
5. Part 11 Approaches to Validation
6. FDA Guidance Documents
7. Procedural and Technical Controls

Section- 4

21 CFR PART 11

• Generating a Checklist for Part 11 analysis
• Write/Understand an SDS ( System Design Specs).
• Build an CFR Part 11 Complaint application
• Execute IQ/OQ scripts

Secton- 5

21 CFR PART 11

• System Testing of the application
• Writing System Test Plan/Scripts and execute.
• Write and Review System Test Summary

 Section- 6

CSV

• Life Cycle Concepts & Deliverables
• Validation (Prospective & Retrospective)
• FDA's Current Guidance
• Write and execute UAT Test plan/Scripts/Summary
• Writing a Validation Plan

Section- 7

CSV

• Understand Operation/Maintenance
• Sign Off process and documents.
• Understanding Production Environment and Emergencies
• Change Control and Remediation Process.
• Creating RTM ( Requirement Trace ability matrix)
• Submission of resume for validation job

Section- 8

CSV

• System Retirement and its process
• Writing Validation Summary Report
• Review of resume and improvements
• Frequently asked questions and preparation for interview
• Conclusion and Question answers
• Test

Project

• Take home Training Database Project
  (MS-Access)

Each Day includes Theory and Lab practice

• Examples based on theory
• Exercises

What You'll Learn

• 21 CFR Part 11 and Computer System Validation concepts, terminology, requirements and techniques.
• Techniques for performing 21 CFR Part 11 Assessments and generating a Gap Analysis
• Writing a Validation/Remediation Plan (RP)
• How to generate the various deliverables using the life cycle approach
• Generation of Test Protocols, Test Scripts and Test Reports
• What SOPs to generate and how ?