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Why Validation Associates

We offer a carefully structured training course covering a wide range of key compliance subject areas. Our main goal is to provide enjoyable, informative and relevant courses that will improve the technical and regulatory knowledge of the attendees in the subject area and make them familiar with current best industry practices.

We hope that this will inspire them to tackle their normal job role with a new level of impetus and confidence.

We believe that our use of a blend of "tried and tested" Industry experts and pharmaceutical compliance professionals with recent "hands-on" experience, puts our pharmaceutical training courses amongst the best available.

All our pharmaceutical compliance and validation training courses are structured with the aim of maximizing the learning experience and levels of enjoyment. This is achieved by ensuring that:

  • The pharmaceutical compliance and validation training course is properly structured in logical chronological order, with sufficient time throughout for discussion and debate.
  • Pharmaceutical training course presentations are clear and maximize the use of visual aids (photographs, videos and diagrams) where possible.
  • Reinforce the messages using "real-life" examples.
  • Our pharmaceutical training course presentations are broken up with ample numbers of group activities that encourage involvement of all the attendees.

Upcoming Training Batches:

  • February, 2023
  • April, 2023
  • June, 2023
  • July, 2023
  • September, 2023
  • November, 2023

Following is the course agenda in brief:

  • Validation: General Overview
  • Types of Validation:
    • Computer System Validation
    • Cleaning Validation
    • Instrument/Equipment Validation
    • Process validation
    • Spreadsheet Validation
  • Validation Process and Deliverables:
    • Software Development Life Cycle
    • Validation Life Cycle
    • Risk Assessment
    • Project Plans
    • Requirements Gathering
    • User Requirements
    • Functional Requirements
    • Design Requirements
    • Validation Plan
    • Validation Protocols and Test Scripts:
      • Installation Qualification (IQ)
      • Operational Qualification (OQ)
      • Performance Qualification (PQ)
    • Traceability Matrix
    • Summary Report
    • Deviations Management
    • Change Control Implementation
    • System Release Memo
    • Standard Operating Procedure (SOP) and Work Instruction (WI)
  • Overview of 21 CFR
    • Overview of Part 11
    • Review of regulations and guidance:
      • 21 CFR Part 58
      • 21 CFR Part 210
      • 21 CFR Part 211
      • 21 CFR Part 820
  • GAMP 4 vs. GAMP 5
  • Introduction to Audits:
    • Audit Preparedness
    • Process for Auditing Computer Systems
    • Audit Checklist

Please contact Sneha for the training curriculum.

Email: sneha@validationassociates.com

Phone: 703-291-0203 x 103