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29 September 2020 – 01 October 2020
3-day course

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.

ITS provides the opportunity of either taking one course alone, a mix of the following courses or all three in their entirety, over consecutive days.

Please see below the content that will be covered by the course. To enrol, click here>>

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Day 1

• Investigate the history and requirements for validation

o What is validation?
o Regulatory requirements and expectations

• Understanding terms and the application of validation

o Discuss the terms used
o Evaluate the key stages of validation
o Use the basic ‘V’ model for a simple approach
o View a CD video and answer questions
o How far does Good Engineering Practice go towards meeting compliance?

• Use case studies to explore the causes and implications of non-compliant validation

o Analyse real scenarios
o Determine suitable actions for workplace improvements

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Day 2

• Identify how GAMP® guidance was developed and the reasons behind it

o Regulatory requirements
o Technological innovation
o Interpretation of rules and regulations

• Review the Life Cycle approach and phases, including: Life cycle concepts; concept, project and retirement

o Practical examples based upon GAMP® categories of software
o Operational phases including: Handover, CAPA, Change management, Security & System administration
o Latest terminology and common themes including, the relationship between qualification terminology and GAMP® 5 activities
o V model approach for IT systems and process control systems
o Categories of software, hardware and the validation approach

• Introducing Quality Risk Management

o An overview of Quality Risk Management
o Description of the risk assessment process including sample risk assessments

• Develop understanding of guidance for supplier activities

o Consider help for suppliers

• Describe regulated company activities to assure computerised system compliance

o Elements to achieve compliance
o Regulatory approach to audits and non-compliance
o Areas particularly vulnerable to non-compliance for manufacturers, and supplier considerations

• Review other GAMP® 5 guidance articles and appendices including:

o Guidance on efficiency improvements
o Appendices: Management, Development, Operation, Special Interest Topics & Other General Appendices

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Day 3

• Understand what the regulation 21 CFR Part 11 is

o What the requirements are
o Why have the regulation?
o The interpretation between guidance and regulation

• Identify key terminology used in the regulation

o Terms and definitions

• Lifecycle of a document

o Electronic
o Hard copy
o Records

• What is in and out of scope?

o Validation requirements for computer systems
o Predicate regulations – what are they, where to look and why?
o A focus on risk to records and the ‘Hybrid’ approach

• Links to validation

o Validation requirements for computer systems

• Training

o Requirements
o Qualifications and experience

• Management of systems

o For open and closed systems
o Physical and logical controls

• Signatures

o Signature/record linking
o Their uniqueness
o Biometrics

• Controls

o Password ageing
o Procedures
o Management responsibilities

• Understand FDA Part 11 Guidance for Industry

o Latest thinking and guidance
o Why the FDA is now assessing whether companies are using the revised guidance

• Recall problems encountered by companies applying the rule

o Potential problem areas
o Case studies
o Differing scenarios/FDA warning letter reviews
o 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

o 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

o Links with GAMP® and risk assessment
o 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:

o European and FDA regulatory guidance
o Challenges to Data Integrity and effective strategies
o Data Integrity control measures

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If you wish to enroll yourself in the course, please secure your place here: http://www.its-ltd.co.uk/training-booking.aspx?course_date_id=3308

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

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