Process Validation and Site Transfer | 5 part-series
Process validations are no longer seen as an isolated process at the end of development or after "site transfers". Today, they are expected to be embedded in a life cycle concept and to comply with QRM principles. With the webinar series, that we have recorded, we give an overview of the recent requirements in this context. The individual webinar parts build on each other. You can stop the recording at any time and thus also view it separately by part.
Part 1 | approx. 75 minutes | Dr. Markus Veit
Regulatory Requirements & Guidance Documents
- ICH | EMA | FDA | ZLG
- General Requirements EU GMP Guide
- Standard versus non-standard manufacturing processes
- Types of process validation (prospective, concomitant, retrospective)
- Documentation: Validation process/ plan/ report: definitions and differences
- Distinct requirements for GMP and dossiers
- GMP and regulatory responsibilities | Regulatory compliance
Part 2 | approx. 75 minutes | Dr. Markus Veit
Live cycle concepts and pharmaceutical development as a prerequisite for process validation
- "Traditional Approach / Hybrid Approach / New Approach"
- Quality Target Product Profile
- Linking CQAs | CMAs | CPPs
- Risk Assessments
Part 3 | approx. 75 minutes | Dr. Markus Veit
Detailed requirements for process validation
- Initial risk assessment
- Use of Prior Knowledge
- Prerequisites for process validation
- Sampling plans and additional testing
- Establishment of acceptance criteria
- Detailed requirements for validation plans and reports
- Simulation of routine conditions during validation
- Requirements for batches
- Handling of deviations
- Establishment of final control strategy
- Release of validation batches
Part 4 | approx. 108 minutes | Dr. Markus Veit
Post validation activities
- Ongoing process verification and control charts
- Change control
- Partial Revalidation
Site transfers
- Prerequisites for site transfers
- Risk assessments needed
- Planning of site transfers and revalidation
- Transfer of information
- Comparability data needed and statistical evaluation | Acceptance criteria
- Responsibilities of parties involved
- Handling of deviations
- Areas of conflict
- Documentation required
- Stability studies
Part 5 | approx. 70 minutes | Dr. Felix Kern
Validation of pharmaceutical packaging
- Guidance documents
- Establishment of critical process parameters
- Control strategy
- Establishment of acceptance criteria
- Life cycle activities
Duration per webinar: approx. 70 - 110 minutes
Lecture language: English| Slides: English
...more from your speaker Dr. Markus Veit...
...more from your speaker Dr. Felix Kern...
Webinars allow you to participate in training courses and lectures conveniently from anywhere at any time. They are the perfect way to keep up to date with the latest knowledge without much effort. You are also welcome to ask the speaker questions after the webinar.
Our special price: Single person booking of the 5-part series at 1300,-- € plus VAT p.p.
If the topics are of interest to several colleagues in your teams, we offer you as a company a special group price:
Note on quota call-off: When booking this webinar series, five unites per participant will be deducted.
- Dr. Felix Tobias Kern
Merck Healthcare KGaA - Dr. Markus Veit
ALPHATOPICS GmbH
E-Learning | Streaming in MP4 format (EN)
Prizes & Conditions of Participation
per person plus VAT. - Payment upon receipt of invoice.
The fee includes for a single booking:
- the one-time viewing of the booked webinar/ or webinar series by the person(s) named to us in advance.
- the receipt of the slides shown as a printable PDF file.
The training is personal and, if booked individually, is for personal training purposes only - not for an entire team. We thank you for your fairness.
Cancellation or change of person is not possible after sending the handout (live: usually 1-2 days before the event | recording: immediately).
Full terms and conditions and participant information can be found here.
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Special prices for team bookings:
If the training is of interest to a group of colleagues, please contact us. Here we offer special group prices for you as a company. The group size is limited to a maximum of 30 participants per webinar. You can participate live or stream the webinar at an individual later time in our video library.
You are interested in a live event but don't have time on the scheduled day of the live webinar?
Then simply ignore the reminder emails about the live event. Our webinar platform will register that you were not present. As soon as the webinar has taken place, you will automatically receive an email from us a few hours later with your personal link to stream the webinar. You can then watch the webinar - individually - whenever your schedule allows. If you have any questions about the content, you are welcome to send them later to fragen@alphatopics(dot)de.
Note on contingent retrieval:
When booking via your company contingent, please note the separate note in the description of the webinar as to how many parts will be deducted from your contingent for the selected webinar, or webinar series.
Save money by booking a quota of 10 and combine any 10 individual webinars (90 min. each) from the topics offered.
Price: 2,500.- € per contingent plus VAT.