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>>
• 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
• 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
• 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
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/
