Process Validation and Site Transfer | 5 part-series (10384)

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.