Overview of GAMP5, Validation, Data Integrity

OVERVIEW

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.

• GAMP5
• 21 CFR part11 compliance
• Annex 11
• ALCOA+
• 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.

Seminar Fee includes:

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