Lynn Bryan, Ballygan Consulting, UK
Dr Line Lundsberg-Nielsen, NNE Pharmaplan, U.K.
Dr Norbert Skuballa, Biologische Arzneimittel Heel, Germany
Dr Wolfgang Schumacher, form. Hoffmann-La Roche, Switzerland
For years, the topic validation/qualification has been among the top deviations in FDA‘s warning letter statistics. This is true both of pharmaceutical manufacturers and of the API industry. Other frequent citations refer to the related topics cleaning validation and change control. What is also checked during inspections – and mentioned in warning letters – is computer validation. In order to give you a broad overview of the cGMP requirements and an update regarding the revised Annex 15 on the whole range of validation / qualification, we have designed the practice-oriented 3-day GMP Education Course “Validation Manager” for you. In many pharmaceutical and API enterprises, the Validation Manager has become an established function.
One focus will be on the FDA Guidance on Process Validation of 2011. What are differences, what are similarities to European validation guidelines?
Parallel workshops on risk analysis and detailed case studies on qualification and validation help to consolidate the theory and demonstrate the practical implementation.
The addressees of the event are qualified staff charged with or responsible for validation activities such as commissioners for validation, heads of quality assurance, department heads, etc. It also addresses members of validation teams (e.g. engineers, chemists, pharmacists, microbiologists) as well as representatives of the plant engineering industry and consultants.
Note: The number of participants is limited to 40 persons.
Each participant receives the Validation/Qualification Aide Memoire (GMP Inspectors Guide) developed by the Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG) – English translation. This 52 page document covers the whole spectrum of validation and qualification (including Cleaning Validation, Validation of Analytical Procedures and Change Control). The Aide Memoire is really helpful as a tool to prepare for an Authority’s GMP Inspection.
Regulatory Requirements on Qualification / Validation Aspects - From history to PAT
- EU GMP guideline and annexes
- Revision of Annex 15 – what is new?
- PIC/S guidelines
- Systematics of plant qualification and process validation
- New approaches to validation
- The FDA Guidance on Process Validation
Validation Master Plan
- Why is risk assessment necessary?
- ICH Q9
- Risk assessment techniques
- Case study
- Differences between PIC/S and Annex 15
- New requirements regarding Annex 15 revision
- Validation Master Plan and Lost Guide
- Why do we do this - history
- Update Annex 15 requirements
- DQ, IQ, OQ, PQ – how the stages of validation fit together
- How to handle qualification logistics?
- Qualification of equipment in use
- The validation life cycle
- Prospective vs concurrent validation
- Is retrospective validation still allowed ?
- Are 3 runs still valid ?
- What does Hybrid Approach mean?
- Revalidation vs Continued Process Verification and Ongoing Process Verification
- Similarities/differences between process validation expectations in US and EU
- Computer Validation
- Organisation of computer validation
- Classification (GAMP® 5)
- Risk analysis
- Change control
- Legacy systems
Qualification/Validation in the Field of API Manufacturing
- Validation protocol
- Risk assessment
- Which limits are acceptable?
- The new PDE approach in Annex 15 revision
- Case study
Guidelines focused on qualification/validation aspects for API production
GMP requirements for qualification/validation in the field of API manufacturing
- Differences to drug manufacturing
- Retrospective qualification
Workshops: We offer four parallel workshops
- Technical change management
- Regulatory change management
- Change management documentation
- Update Annex 15 requirements
You can take part in one of these workshops.
Workshop 1: Organisation of Validation
An interactive workshop to find out and discuss how
validation activities can be implemented in an existing QM System and how to write a Validation Master Plan
Workshop 2: Risk Assessment Qualification
In the workshop you look at risk assessment associated with qualification activities in a typical production environment. You will assess a new filling line as per the ISPE baseline guide to create an impact assessment plan. This plan will then be translated into requirements for validation and the resultant tests associated with the validation steps of DQ through to OQ.
Workshop 3: Risk Assessment Process Validation
An interactive workshop with practical examples and exercises on the application of Quality Risk Management for validation of a tabletting process
Workshop 4: Risk Assessment Cleaning Validation
An interactive workshop to find out and discuss GMP-relevant aspects of the validation of cleaning with the focus on calculating of acceptance criteria.