IPEC-Americas Headquarters located at 3138 N. 10th Street, Arlington, Virginia 22201
Fifth Floor Conference Room - Please check in with security
- Thursday, 7 Dec: 1 pm – 5 pm EST (lunch not included)
There will be an optional networking dinner Thursday December 7th and details will be discussed at the opening of the course.
- Friday, 8 Dec: 8 am – 12 noon (continental breakfast and box lunch included)
Risk assessment is already a hot topic for excipients and becoming more important all the time. Excipient makers have not always had the same level of need or opportunity as excipient users (pharmaceutical companies) to conduct risk assessments within their manufacturing processes.
This workshop will focus on the techniques used to conduct them, such as FMEA, FTA, HACCP, HAZOP, etc. Using plausible but fictitious case studies and exercises, participants will spend most of their classroom time developing risk assessments.
Participants will have pre-workshop reading assignments to be completed prior to the workshop which will be key to maximizing learning.
Quality, regulatory affairs, and manufacturing employees of excipient manufacturers
- Describe and demonstrate various techniques for performing excipient-focused risk assessments
- Describe and demonstrate several methods for reducing and / or mitigating risks
- Describe the risk assessment elements which apply to the European Falsified Medicines Directive and the difference in the approach taken by US NSF/IPEC/ANSI 363 and EXCiPACT.
- Describe and demonstrate (if applicable) the application of risk assessment to atypical actives.
- Describe and demonstrate (if applicable) how to audit risk assessments.
Ann Van Meter recently retired as Business Quality Leader and GMP Subject Matter Expert for Dow Pharma and Food Solutions. She was employed by the Dow Chemical Company for 25 years. A chemical engineer by training, Ann has held a variety of EHS and Quality Roles throughout her career. Prior to her retirement, Ann was actively engaged as the Dow representative in the International Pharmaceutical Excipients Council. She also served as chair of the GMP Committee and as a member of the Executive Committee. She led the Validation Task Team and the Technically Unavoidable Particles Work Group.