Dr. Wolfgang Schumacher
ehem. F. Hoffmann-La Roche
Referent:innen
Dr Line Lundsberg-Nielsen
NNE
Dr. Norbert Skuballa
Biologische Heilmittel Heel
All times mentioned are CET.
Zielsetzung
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 on the whole range of validation/qualification, we have designed this practice-oriented 2-day Validation Manager GMP Education Course. 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?
Zielgruppe
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.
Technical Requirements
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Programm
Gesamtes Programm als PDF herunterladen
Risk Assessment
- Why is risk assessment necessary?
- ICH Q9
- Risk assessment techniques
- Case study
Validation Master Plan
- Target
- Format
- Content
- Differences between PIC/S and Annex 15
- New requirements regarding Annex 15 revision
- Validation Master Plan and Lost Guide
Overview Analytical Method Validation
- ICH Q 2
- ICH Q 14
Qualification
- 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?
- Re-qualification
- Qualification of equipment in use
Case Study Qualification
- The case study describes how a purified water system can be qualified according to cGMP.
Validation
- 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
- Pitfall
Case Study Process Validation
- The case study describes a process validation study of a tabletting process.
Computer Validation
- Organisation of computer validation
- Classification (GAMP® 5)
- Risk analysis
- Change control
- Legacy systems
Cleaning Validation
- Validation protocol
- Risk assessment
- Sampling
- Which limits are acceptable?
- The new PDE approach in Annex 15 revision
- Case study
Qualification/Validation in the Field of Chemical APIs
- 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
- Revalidation
- Pitfalls
Change Management
- Technical change management
- Regulatory change management
- Change management documentation
- Update Annex 15 requirements
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Tel.: +49 6221 84 44 0
E-Mail: info@concept-heidelberg.de
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