DUBLIN--(BUSINESS WIRE)--The "Process Validation with Qualification" conference has been added to ResearchAndMarkets.com's offering.
The two-day process validation in the US and EU, balancing science and risk during the product lifecycle meeting will help you gain an understanding of the EU and FDA process validation guidance, learn how to establish a process validation programme, under the link between Quality by Design and process validation as well as how to apply relevant tools for process validation including risk assessment.
Gain a comprehensive understanding of the EU and FDA Process Validation Guidance, how to establish a Process Validation Programme, understand the link between quality by design and process validation, apply relevant tools for process validation including risk assessment
Benefits in attending:
- Know the scope of the FDA and EU validation guidelines
- Establish a 3 stage, science-and-risk-based, lifecycle process validation programme
- Clarify similarities and differences between EU and US expectations, with consideration of differing company requirements eg innovative to generic manufacturers
- Understand how Quality by Design supports process validation
- Link product requirements, to equipment verification to commercial scale process validation
- Gain knowledge in qualification including Good Engineering Practice (GEP)
- Apply tools such as Quality Risk Management, Design of Experiments and Statistics
- Unscramble the real meaning of buzz words' such as qualification, verification, commissioning, calidation etc.
- Realise significant business benefits from taking a science and risk-based approach
This seminar will be of particular interest to all those from the Pharmaceutical Industry working in:
- Development
- Manufacturing
- Engineering
- Quality
Personnel from the pharmaceutical and biopharmaceutical industry with the following background:
- Process engineers
- Pharmacists
- Scientists
- Quality assurance professionals
- Quality control managers
- Late stage product and process development engineers, scientists, pharmacists
- Technology scale-up and transfer managers
- Validation and qualification managers
- Validation and qualification specialists
- Risk management specialists
- Lean management specialists
- Operations managers and engineers
For more information about this conference visit https://www.researchandmarkets.com/research/ds42rv/process?w=4
