Regulatory Requirements & Guidance Documents (Part 1 - Process Validation and Site Transfer) (10385)

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.

The following contents are addressed in this individual section:

• 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

Duration of the recording: approx. 75 minutes
Lecture language: English | Slides: English

...your speaker Dr. Markus Veit...

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 for the whole series: Single person booking of the 5-part series at 1300,-- € plus VAT p.p.

Note on quota call-off: When booking this single part described here, one unit per participant will be deducted. When booking the entire webinar series, five units per participant will be deducted.

For team training, please contact us.