Live Online Training: The Validation Manager in the Pharmaceutical Industry

Live Online Training: The Validation Manager in the Pharmaceutical Industry

Course No 18672

 

Costs

ECA-Member: EUR 1590,--
Non ECA Member: EUR 1790,--
EU/GMP Inspectorates: EUR 895,--
APIC Member Discount: EUR 1690,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Lynn Bryan, Ballygan Consulting, UK
Dr Line Lundsberg-Nielsen, Lundsberg Consulting Ltd, UK
Dr Wolfgang Schumacher, form. Hoffmann-La Roche, Switzerland
Dr Norbert Skuballa, Biologische Arzneimittel Heel,  Germany

Objectives

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 3-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?

Target Group

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

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

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 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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