Identifying Appropriate-Quality Pharmaceutical Raw Materials in an Evolving Regulatory Environment
Thursday, January 18, 2018
This webinar will discuss appropriate quality attributes for different raw material uses, present strategies to support identification, selection and risk assessment of raw materials, and highlight the importance of regulatory documentation.
Recent and continuing regulatory improvements require drug manufacturers to assess and mitigate risk throughout their entire processes. This includes raw materials used at every stage of manufacturing and clinical phases. Current regulatory guidelines and industry standards clearly define quality requirements for raw materials that are incorporated into, or used close to, final drug product, for example active ingredients and excipients. However, no such clear standards are defined for chemicals used earlier in the process, such as in upstream bioprocessing, early chemical synthesis stages, or clean-in-place. The absence of such standards presents a challenge to efficiently and effectively source raw materials with appropriate supply chain transparency and control, accompanied by the necessary supporting documentation.
In this webinar, you will learn:
- Strategies to support identification, selection, and risk assessment of raw materials throughout the manufacturing process
- Appropriate quality attributes for different raw material uses
- The importance of quality and regulatory documentation provided by the supplier
Sessions 1 & 2 Presenter
Douglas Bowman has 20 years' experience in the life sciences industry. He has worked in various geographical locations and in a wide range of functions, including sales, marketing, supply chain and quality. Douglas is currently responsible for the integration and expansion of the Emprove® and PharmaGrade™ Programs at our company. He is also a qualified GMP auditor and is a member of our Life Science supplier audit team.