- Datum:
-
- Seminar
The Validation Manager in the Pharmaceutical Industry
- Veranstaltungsort:
- Barcelona
- Veranstalter:
- CONCEPT HEIDELBERG GmbH
Overview
Regulatory Requirements on Qualification / Validation Aspects – From History to PAT
- EU GMP guideline and annexes
- Annex 15 revision
- PIC/S guidelines
- Systematics of plant qualification and process validation
- New approaches to validation
- The FDA Guidance on Process Validation
Industrial View
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
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 cGMP.
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 case study describes a process validation study of a tabletting process.
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
- Pitfalls
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 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
- Revalidation
- Pitfalls
Change Management
- Technical change management
- Regulatory change management
- Change management documentation
- Update Annex 15 requirements
WORKSHOPS
We offer four parallel workshops. You can take part in one of the workshops.
We offer four parallel workshops. You can take part in one of the workshops.
Workshop 1
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
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
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.
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.
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.
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.
CONCEPT HEIDELBERG GmbH
Rischerstraße 8
69123 Heidelberg
Deutschland
Telefon: +49 6221 844415
Telefax: +49 6221 844464
eMail: info@concept-heidelberg.de
Internet: http://www.gmp-navigator.com/
