2-Day In-Person Seminar

    Overview of GAMP5, Data Integrity, 21CFR part11, Computer System Validation and Avoid Warning Letter (483’s)

    Kalpeshkumar  R. Vaghela speaker of Training Doyens
    Speaker: Kalpeshkumar R. Vaghela
    Location : Mumbai, India
    Date : November 23rd and 24th 2017
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This seminar on CSV will explore proven techniques for reducing costs linked with implementing and maintaining computer systems in regulated environments. This course will not only provide a full understanding of the regulations and guidelines for raw data and other records but also provide templates and examples to develop inspection ready documentation.
The important topic that will be discussed by our expert in this seminar is about the GAMP approach to 21 CFR Part 11 compliance, as well as compliance with other international regulations covering ERES.

Our instructor will quote examples and real life scenarios to better demonstrate the application of the techniques for any validation project. This seminar will also demonstrate how current Part 11 requirements will be met using recent warning letters as examples. By attending this seminar, you will be able to avoid warning letters, cut down costs, improve quality, and compliance with minimum documentation.

• 21 CFR part11 compliance
• Annex 11
• Data Integrity
• Risk Assessment and case Studies
• 483 Warning Letter

why should you attend

Get the concentrated inputs from Industry leader who is constantly involved in Computer Systems Validation in India and Abroad.
• Bullet point on how to perform best can help you and your company produces great compliant results.
• Reduce the professional stress by mastering the CSV.  It is the most troubling issue of the time for all pharma company.
• Make gain for your Company and thereby increasing your professional Success.
• To make Pharma People aware about latest regulatory Guidelines.
• Motivate them to learn it and help them avoid 483, Warning Letter and data Integrity related issues.
• Provide ROI in the form of improved Quality, Less rejection and Confidence of doing it Right For the First time

Areas Covered

• To make Pharma People aware about latest regulatory Guidelines.
• Achieve QbD and Right First-Time approach by procuring correct System.
• Understand CSV Deliverables, Risk Assessment, URS (User requirement Specifications), IRA (Initial Risk Assessment), Validation Plan, Functional Risk Assessment, Installation – Operational Qualification, Traceability matrix and Summary report.
• Black Box and White Box Validation.
• ERES, Hybrid and paper based System and How to control the risk.
• Past experience and feedback suggest we try to get answer for all your queries related to CSV and Data Integrity.
• Have good Control on SDLC Life Cycle, Data Life Cycle and GxP Work flow.

Who Will Benefit

• Information Technology Managers,
• Information Security Managers
• and Administrators,
• Quality Managers, Compliance officers,
• Quality Officers,
• Risk Managers,
• Implementers for compliance and security frameworks.
• Managers & Supervisors
• Validation Specialists
• SME QA-QC-Engg.-Project-Production- Documentation
• Consultants & System Administrators
• Sr. Managers- Module Leader- Team leaders
• Analytical Experts
• Laboratory Supervisors & Managers
• Documentation Specialist
• GM, VP, CIO of QA, QC, IT, Validation and Project- Engg

Learning Objectives

The objective of the training is to cover the following:
• Overview of regulations like 21CFR Part 11, GAMP 5 etc.
• Software validation concepts CSV Deliverables.
• Data Integrity and Security
• The workshop offers the opportunity to understand basics in Computer System

Key Take Away

• Make Data Integrity and CSV Easy to understand and ACT. Train whole company team on this issue later on.
• Stay away from 483-warning letters. Be aware about latest regulatory Guidelines and predicate rules to achieve and maintain cGXP Compliance.
• Provide ROI in the form of improved Quality, less rejection and Confidence of doing it Right For the First time
• Save Market Capital of your Company Stock price.

Click to View the Pricing Plan

Seminar Fee includes:

Lunch Beverages Seminar Material USB with seminar presentation Presentation Printouts Participation Certificate


Day One (8:30 AM - 4:30 PM)
Registration Process: 8:30 AM – 9:00 AM

Day 1- Session I – Morning

  • Validation Definition
  • SDLC Life Cycle Approach for System and Data
  • Importance of IT knowledge at URS stage can save you from Data Integrity and other 483 issues
  • V Module/ 4Q Approach
  • Predicate Rules
  • How we can Design and purchase Good System. Importance of Good URS
  • GAMP5 Basics& Risk Based Approach
  • GAMP5 Drivers and Deliverables of CSV
  • Importance of Computer Systems Validation and what system needs Validation?
  • Definition Qualification / Validation
  • Why Calibrate Instrument & Sensors?
  • Benefits of Validation
  • GAMP4 V/S GAMP5 Difference
  • Software and Hardware category as per GAMP5
  • Difference in validation Documents as per Software Category
  • Software category For Lab Instruments
  • Main points

Day 1- Session II – Afternoon

  • Legacy System
  • Open System
  • Close System
  • Electronic Records
  • Hybrid Systems
  • Electronic Signature
  • Digital Signatures
  • Black box
  • White box
  • Paper base System and Electronic System Audit Trail is same.
  • Data backup – Restoration, Archival- Retrieval and data Retention.
  • DR Server
  • Annex 11
  • Data Integrity and Security
  • QSIT

Day Two (8:30 AM - 4:30 PM)
Registration Process: 8:30 AM – 9:00 AM

Day 2- Session I- Morning

  • How validation helps to improve your business
  • Computer Validation as per GAMP5
  • Deliverables of the Validation
  • VMP, URS, FS, DS, GAP, IRA, VP, FRA, IQ, OQ, PQ, TRM, Summary Report.
  • Validation approach for different type of the system PLC-MMI, PLC- IPC, PLC-IPC-Server, Cloud.
  • How to write Meaning Full URS, GxP Assessment
  • Using risk based approach for CSV
  • Benefit of Risk Assessment
  • Risk Assessment SOD, RPN no.
  • Selecting and qualifying the right vendor – Risk Based Approach as per GAMP category
  • Installing and testing the system for correct operation
  • Validation of existing system
  • Vendor Qualification, SLA, Inventory List, TRM,  Annex 11
  • Disaster Control and Business Continuity Planning
  • Maintenance Qualification
  • Patch Management
  • Periodic Review

Day 2- Session II - Afternoon

  • Revalidation
  • Data Migration and Deletion, Read Only Mode
  • System Retirement
  • Data Integrity
  • Warning Letters
  • Audit point in last two years
  • Cloud Systems Validation in brief.
  • 483 –warning letters are key wealth destroyer for Pharma company Market Capital and Reputation
  • How to reduce or control Data Integrity Issues as far as CSV, GAMP5 and 21 CFR part 11 is concerned in Automated Systems


Mr. Kalpeshkumar R. Vaghela is the CEO of Infra Control Systems. He has 30 years experience as  Software Validation Specialist, Expert Trainer CSV-  Data Integrity- GAMP5- 21 CFR part 11 Compliance- ICH Q9, Risk assessment- Proactive CSV Approach .  Since last two decades Mr. Vaghela has been helping Indian and International Pharma Companies achieve compliance by training and motivating professionals for QbD and Right First Time Approach. He has supported client for many USFDA, MHA, ANVISA, MCC, and TGA Customer Audits as a CSV consultant.

About 11 years of work experience on high level CSV Validation in India and Abroad has made Mr. Vaghelaa Subject matter expert in CSV, Data Integrity Audit for Life Science- Medical Device and Clinical Research Industry. He is also conducting Governance-Risk and Compliance Seminar for It Giants like Wipro, HCL technologies Etc.

He has worked with 80% of Most big pharma Companies as a CSV Consultant and Trainer. He has close to a decade of international experience of working with companies located in USA, Canada, Europe, South America, Norway, Africa, Middle East, China, Japan and Far East. Wherever he has worked and trained, he has unanimously been recognized as a brilliant course director and guide.


Contact info


Mumbai, India


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