The Validation Manager in the Pharmaceutical Industry

The Validation Manager in the Pharmaceutical Industry

Heidelberg, Germany

Course No 17915



ECA-Member: EUR 1790,--
Non ECA Member: EUR 1990,--
EU/GMP Inspectorates: EUR 995,--
APIC Member Discount: EUR 1890,--

(All prices excl. VAT)

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


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


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?
Parallel workshops on risk analysis and detailed case studies on qualification and validation help to consolidate the theory and demonstrate the practical implementation.

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.

Note: The number of participants is limited to 40 persons.


Qualification and Validation – Basic Requirements  Aide Memoire (GMP Inspectors Guide)
The Guide is developed by the Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG) – English translation. This 20 pages document covers responsibilities, risk assessments, documentation (VMP protocols, reports), inspection of premises and equipment, qualification requirements (URS, DIOPQ), qualification of identical equipment, requalification).



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
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
  • 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.
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
  • Pitfall
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
4 Parallel Workshops
We offer four parallel workshops. 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 acceptance criteria.

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