An Introduction to Risks associated with Extractables, Leachables & Elemental Impurities in cGMP Manufacturing: A Project Managers Perspective 2017 is a webinar that covers topics such as:
- Introduction of the Presenter
- Ntroduction of the Topic
- Definition of Extractables
- Safety Minute
- Definition of Environmental Impurities
- Definition of Leachables
- Risks - Quality Considerations
- Review of Regulatory Guidance
- Risks - Efficacy Considerations
- Risks - Safety Considerations
- Case Study - Product Development
- Case Study - Materials Management Program
- Lessons Learned
- Case Study - Direct Impact Critical Utilities
- Review
- Conclusions
An Introduction to Risks associated with Extractables, Leachables & Elemental Impurities in cGMP Manufacturing: A Project Managers Perspective 2017 is intended for personnel of pharmaceutical companies and their suppliers.