Use of SPC in the Biopharmaceutical industry: use and implementation
Instructor:
Jeffrey Staecker
Product ID: 705074
- Duration: 60 Min
Why Should You Attend:
There are many descriptions of SPC, SPC (Run) “Rules”, and how to apply SPC that can lead to confusion and/or institution of SPC that entails significant resources with minimal return. This webinar explores what SPC is, some of the different run rules that can be utilized, and different types of flags, alerts, or investigations that can be utilized in responding to events identified using SPC. Perspectives of contract testing and manufacturing perspectives on SPC will be discussed and ideas on how best to implement SPC with outside groups will be provided.
Learning Objectives:
- Develop an understanding of SPC principles
- Learn about various run “rules” used for SPC
- Obtain a perspective different SPC approaches based on particular applications
- Leverage knowledge in applying SPC
- Understand how SPC fits into the larger quality system
- Leveraging method monitoring (SPC) to efficiently transfer methods and reduce long-term risk
- Understand challenges faced by contract organizations in implementing SPC
Who Will Benefit:
- Team members involved in monitoring processes or methods
- QA representatives involved in SPC or integrating SPC into the Quality System
- Auditors interested in learning about SPC in preparation of audits
- Technical representatives for groups involved in process performance
- Managers responsible for driving quality improvements
- Statisticians involved in implementing or executing SPC
Jeffrey Staecker
Principal Consultant, BioPhia Consulting
Jeff Staecker has worked in GMP industries for over 25 years whose experience covers a breadth of functional responsibilities (QC, QA, R & D, manufacturing) as well as working for manufacturers, a contract testing organizations, and contract manufacturing organization. Responsibilities have included oversight of groups of more than 70 individuals, large budgets, as well as individual responsibilities such as leading risk assessments, technology transfer, and consent-decree remediation activities. Jeff has had multiple roles in method transfers for more than 20 years and recently (January 23) co-chaired and presented at an international meeting “Methods on the Move: Addressing Method Transfer Challenges for the Biopharmaceutical Industry” (http://www.casss.org/page/CMCJ1700).
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