29-31 March 2023
Lynn Bryan BSc. (University of Liverpool), P.G.C.E (University of Reading), Ballygan Consulting, U.K.
Dr Line Lundsberg, Lundsberg Consulting Ltd, U.K.
Dr. Norbert Skuballa, Biologische Arzneimittel Heel, Germany
Dr Wolfgang Schumacher, formerly F. Hoffmann-La Roche Ltd., 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 an broad overview of the cGMP requirements 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 from 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.
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
- Why is risk assessment necessary?
- ICH Q9
- Risk assessment techniques
- Case study
Validation Master Plan
- 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
Case Study Qualification
The case study describes how a purified water system can be qualified according cGMP.
Case Study Validation
The case study describes a process validation study of a tabletting process.
- 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
- Organisation of computer validation
- Classification (GAMP 5)
- Risk analysis
- Change control
- Legacy systems
- Validation protocol
- Risk assessment
- Which limits are acceptable?
- The new PDE approach in Annex 15 revision
- Case study
Qualification/Validation in the Field of chemical API Manufacturing
- 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
- Technical change management
- Regulatory change management
- Change management documentation
- Update Annex 15 requirements
We offer three parallel workshops. You can take part in one of the workshops.
Organization 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
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.
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.
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.
For all participants:
Free download: ECA´s „Integrated Qualification and Validation Good Practice Guide“ - A guide to effectie qualification based on Customer – Supplier Partnership
Add-on: Qualification and Validation – Basic Requirements Aide Memoire (GMP Inspectors Guide).