Understanding Validation, GAMP® 5, 21 CFR Part 11 and Data Integrity Training Programme

The Understanding Validation, GAMP® 5, 21 CFR Part 11 and Data Integrity Training Programme can be delivered in a hotel, one of our offices, your premises or online via a virtual classroom. The course content can be tailored to meet your requirements. Request a quote for an onsite or online virtual course for an agreed number of delegates from your site.

The purpose of the Understanding Validation, GAMP® 5, 21 CFR Part 11 and Data Integrity (3 Day) Training Programme is to provide learners with the opportunity of either taking one course alone, a mix of the following courses or all three in their entirety, over consecutive days.

The complete programme allows learners to build a basic knowledge of validation through to the latest GAMP® 5 guidance, and then on to specific American regulatory requirements for 21 CFR Part 11 Electronic Records; Electronic Signatures.

The programme comprises Understanding Validation Training (Day 1), GAMP® 5 Training - Fundamentals of GAMP® 5 Guidance Training (Day 2), and Interpreting 21 CFR Part 11 and Revised EU Annex 11 and Data Integrity Training (Day 3).

• Investigate the history and requirements for validation
• What is validation?
• Regulatory requirements and expectations
• Understanding terms and the application of validation
  • Discuss the terms used
  • Evaluate the key stages of validation
  • Use the basic 'V' model for a simple approach
  • View a CD video and answer questions
  • How far does Good Engineering Practice go towards meeting compliance?
• Use case studies to explore the causes and implications of non compliant validation
• Analyse real scenarios
• Determine suitable actions for workplace improvements

Day 2

• Identify how GAMP® guidance was developed and the reasons behind it
• Regulatory requirements
• Technological innovation
• Interpretation of rules and regulations
• Review the Life Cycle approach and phases, including: Life cycle concepts; concept, project and retirement
• Practical examples based upon GAMP® categories of software
• Operational phases including:
• Handover
• CAPA
• Change management
• Security 
• System administration
• Latest terminology and common themes including, the relationship between qualification terminology and GAMP® 5 activities
• V model approach for IT systems and process control systems
• Categories of software, hardware and the validation approach
• Introducing Quality Risk Management
• An overview of Quality Risk Management
• Description of the risk assessment process including sample risk assessments
• Develop understanding of guidance for supplier activities
• Consider help for suppliers
• Describe regulated company activities to assure computerised system compliance
• Elements to achieve compliance
• Regulatory approach to audits and non-compliance
• Areas particularly vulnerable to non-compliance for manufacturers, and supplier considerations
• Review other GAMP® 5 guidance articles and appendices including:
• Guidance on efficiency improvements 
• Appendices: 
• Management
• Development
• Operation
• Special Interest Topics
• Other General Appendices

Day 3

• Understand what the regulation 21 CFR Part 11 is
  • What the requirements are
  • Why have the regulation?
  • The interpretation between guidance and regulation
• Identify key terminology used in the regulation
  • Terms and definitions
• Lifecycle of a document
  • Electronic
  • Hard copy
  • Records
• What is in and out of scope?
• Validation requirements for computer systems
• Predicate regulations - what are they, where to look and why?
• A focus on risk to records and the 'Hybrid' approach
• Links to validation
  • Validation requirements for computer systems
• Training
  • Requirements
  • Qualifications and experience
• Management of systems
  • For open and closed systems
  • Physical and logical controls
• Signatures
  • Signature/record linking
  • Their uniqueness
  • Biometrics
• Controls
  • Password ageing
  • Procedures
  • Management responsibilities
• Understand FDA Part 11 Guidance for Industry
  • Latest thinking and guidance
  • Why the FDA is now assessing whether companies are using the revised guidance
• Recall problems encountered by companies applying the rule
  • Potential problem areas
  • Case studies
  • Differing scenarios/FDA warning letter reviews
  • How the FDA used to audit and report compliance issues to where they are now
• Identify and review EU GMP Annex 11 revised guidance on Computerised Systems focusing on records and signatures
• Review includes:
• Corresponding GMP Volume 4 Guide, revision of Chapter 4 Documentation
• Updates from previous revision of Annex 11
• Cross reference to Part 11
• Describe the GAMP® approach to 21 CFR Part 11 compliance
• Links with GAMP® and risk assessment
• Use GAMP® risk assessment to assess a potential real scenario
• Explore the subject of data integrity and understand the reasons for the current regulatory focus including:
• European and FDA regulatory guidance
• Challenges to Data Integrity and effective strategies
• Data Integrity control measures

ISPE owns the GAMP® trademark http://www.ispe.org/

This course can be delivered to a group of up to 12 delegates at your premises or as an online virtual classroom course for an agreed number of delegates from your site. Request a quote.

“Found the general overview very useful and the last session going through the V model – excellent.”
Open course delegate

“Trainer was very good at adapting course content to reflect the unique nature of our industry.”
Open course delegate

“Gave a good, clear understanding of a V model.”
Open course delegate

“Alan was quite happy to adapt his plans to suit the needs of attendees rather than sticking to a script.”
Open course delegate

“Very well run course. I got a lot out of it. Good venue and food a bonus.”
Open course delegate

“The course contents were interesting.”
Open course delegate

“Enjoyable course delivered at correct pace.”
Open course delegate

“Well delivered and a good insight to validation. Anybody involved should attend.”
ITS Ltd

“Course organisation was pro-active and flexible to meet my attendance needs.”
ABB

“Well presented, good information.”
Roslin Cells Ltd

“Highly recommended as the course is very thorough and provides in-depth information.”
Nerudia Ltd

“Very informative.”
Nerudia Ltd

“Well presented with clear explanation and helpful exercises.”
Domino UK

“Very useful.”
Domino UK

“Very good speaker, venue and value.”
MedGenesis Ltd

“It is a good course with valuable content to take away for further readings.”
Synergy Health Plc

"I would say yes, as it was well structured and the trainer was very knowledgeable about the subject”
KWC Professional Solutions Ltd

“Yes, very informative, lots of experience and value for money”
Recipharm Ltd

“Yes, Training was thorough and complete hand outs and accompanying literature was excellent”
Recipharm Ltd

“Yes, Was valuable and gave good update, new regulations”
Recipharm Ltd

“Yes, Informative and professional”
Recipharm Ltd

“Yes, Detailed and Informative”
Recipharm Ltd

“Yes, Informative”
Recipharm Ltd

ITS’ Regulatory Compliance Trainer, Dr Jennifer Thompson, has over 20 years of experience in the pharmaceutical sector in computer systems validation and IT infrastructure controls and compliance and has delivered projects for a wide range of companies in the UK, EU and USA including GlaxoSmithKline, Novartis Healthcare, Lonza Biologics, Elan Pharmaceuticals, Hoffman LaRoche and others. Her experience covers computerised systems used in manufacturing, laboratories, enterprise systems and clinical trials management. She has written articles and given presentations on a wide range of topics and contributed to the GAMP® Good Practice Guide “A Risk-based Approach to GxP Process Control Systems” and “The Risk Based Compliance Handbook” by Siegfried Schmitt (Paraxel).

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