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GMP Courses and Conferences

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Tuesday, 28 May 2024 9 .00 - 16.15 h

Speakers


Dr Wolfgang Schumacher, SPC, formerly F. Hoffmann-La Roche Ltd., Switzerland

Objectives


In order to give you a concentrated one-day overview of the cGMP requirements regarding Process Validation and Equipment Qualification, the ECA has designed the practice-oriented 1-day GMP Education Course “Validation/Qualification for Beginners” for you. There will be also short overviews about Cleaning Validation and the Validation of Computerised Systems.

Among other things, these questions will be discussed:
  • Differences between URS and FDS?
  • Are FAT and SAT mandatory? If not, how to use?
  • Do we have to follow an 8-step qualification process in in
  • Europe?
  • Is a PQ mandatory?
  • Is an integration of ASTM 2500 in Annex 15 requirements
  • possible?
  • How to handle Equipment Qualification with equipment in use?
  • Requalification – when, what, how often?
  • What are the differences between PQ in FDA requirements and PQ regarding Annex 15?
  • Are PPQ and Process Validation the same?
  • What are differences between Continued Process Verification (US) and Ongoing Process Verification (EU)?
  • Continuous Process Verification – a new concept?
  • Are statistics mandatory in Process Validation?
  • PDE – a “new” concept in Cleaning Validation
  • What has changed with GAMP 5 revision 2?
  • Analytical Method Validation on the move – ICH Q14

Background


Process Validation and equipment qualification are essential requirements in GMP. With the revisions in FDA Process Validation Guidance and the EU GMP Guide Annex 15 an Process Validation life cycle has been introduced. Risk analysis is the new “buzz word” in validation and qualification.
 
In the majority of GMP inspections Process Validation and Equipment Qualification aspects are covered. Although there are guidelines from the EU (Annex 15) and the FDA (Process Validation Guidance) details are still open or not well explained. Also other regulatory guidelines (WHO, ASTM…) don´t give hints in details. So, there is a lack of Interpretation.

Target Group


The addressees of the event are beginners involved in Process Validation and Equipment Qualification activities such as Subject Matter Experts for validation, heads of quality assurance, engineering department heads, etc. It also addresses members of validation teams (e.g. engineers, chemists, pharmacists, microbiologists) as well as representatives of the plant engineering department  and consultants, who wants to get an insight of the Topics.

Programme


Regulatory Requirements
  • EU GMP guideline and annexes
  • PIC/S guidelines
  • FDA 21 CFR 210/211 and Guidances for Industry/Guide to inspection of…
  • WHO
  • Validation Master Plan
  • Requirements according Annex 15
Risk Assessment 
  • Why is risk assessment necessary?
  • ICH Q9 revision 1
  • Risk assessment techniques and tools
  • Case study
Qualification
  • Annex 15 requirements
  • FDA requirements
  • URS, FDS, DQ, FAT, IQ, SAT, OQ, PQ – how the stages fit together
  • How to handle qualification logistics?
  • Re-qualification – when, what, how often?
  • Qualification of equipment in use
  • ASTM 2500 vs Annex 15
  • When does calibration happen?
Process Validation
  • The validation life cycle
  • Prospective vs concurrent validation
  • Are 3 runs still state of the art?
  • What does Hybrid Approach mean?
  • Revalidation vs. Continued Process Verification and Ongoing Process Verification
  • Similarities/differences between Process Validation expectations in US and EU
  • Overview: Cleaning Validation
  • Overview: Validation of computerised Systems
Analytical Method Validation
  • ICH Q2 R1
  • Verification of compendial methods
  • Method transfer
  • Recap of the most important analytical Parameters
Change Control
  • GMP vs Marketing Authorisation – an important distinction during Change Control
  • The Change Control Process
  • Who is involved?
  • Like-for-like changes
Q & A Sessions
 
Two Q &A sessions ensure interaction and that your questions are answered.

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.