Validation/Qualification for Beginners - Online Training Recording
Course No. 23021
Speakers
Dr Wolfgang Schumacher
SPC – Schumacher Pharma Consult, formerly F.Hoffmann-La Roche
Basics about Qualification and Validation
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.
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 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.
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
Further Information
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration: When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. Starting with the access date you entered in the registration process the stream will be available to you for 7 days. Within in this period you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate: The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
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