- Datum:
-
- Webinar
Ongoing/Continued Process Verification - Live Online Training
- Veranstaltungsort:
- online
- Veranstalter:
- CONCEPT HEIDELBERG GmbH
Overview: The new process validation guides from FDA and EMA and the new industry guides from ISPE, PDA and ECA: content and principles
- How the concept of Process Validation is about to change
- Comparison of Annex 15 revision with FDA Process Validation Guidance
- Real-life examples
Ongoing Process Verification – View of an EU Inspector
- EU Process Validation Lifecycle approach (overview)
- EU GMP requirements on EU-OPV
- Authorities expectations reg. PQR and link to OPV
- Comparison of EU and US requirements reg. OPV/CPV
Case Study: From Control Strategy to Trending
- Introduction in Biopharmaceutical Processes
- Process development and definition of parameters
- Parameters and control
- Control Strategy
- Process Performance Validation Approach
- Statistical Process Control
Case Study: Large Molecules - Process Validation and Statistical Trending in Biopharmaceutical Manufacturing
- Basic Statistics
- Content of CPV protocol/report
- Trending program and related procedures
- Evaluation of Trends and CAPAs
- Link to APR/PQR
Medical Device and Pharmaceuticals: Similar Expectations and Approaches
- Leveraging experience
- Quality System similarities
- Standard Approaches – foundation for implementation
Recent trends in FDA inspections, observations and warning letters
- Examples of expectations and enforcement
- Regulatory enforcement trends related to observations and Warning Letters
Case Study: SPC as tool for Continued Process Verification
- Continued Process Verification: Requirements
- Case Study Sanofi-Aventis
Case Study: How to implement CPV of a Legacy Process
- Challenges
- Experiences
- Lessons learnt
The future role of PAT, industrial IT and automation in Continued Process Verification: Implementing a Control Strategy
- Control strategy and implications for automation solutions
- Bridging islands of information systems in manufacturing
- From data to information to knowledge: getting gold out of data
- Continued process verification: monitoring challenges
- Window to the Quality: The future role of automation and IT systems in manufacturing?
CONCEPT HEIDELBERG GmbH
Rischerstraße 8
69123 Heidelberg
Deutschland
Telefon: +49 6221 844415
Telefax: +49 6221 844464
eMail: info@concept-heidelberg.de
Internet: http://www.gmp-navigator.com/
