Continuing Education – Evening Lecture
Overview of Pharmaceutical cGMP Regulatory Requirements and Facility Design
Presenter: Kristina Pumphrey, M.Sc., P.E.
Director, Process Engineering
Precis Engineering, Inc.
Thursday, May 19, 2022
5:30pm-6:30pm – Presentation (Eastern time)
6:30pm-6:45pm – Q&A Session & Closing Remarks
PDH Credit: 1 credit
Location: Due to COVID, this will be an online presentation only
Price:
$10 each for attendees
Abstract:
The pharmaceutical industry is a very regulated industry to ensure the quality and safety of medicines for patients. The FDA’s current Good Manufacturing Practices (cGMP) regulations guide the design, monitoring, operations, and maintenance of manufacturing facilities. The presentation will give an overview of cGMP requirements and how it translates into the engineering and design of the manufacturing facility.
Biography:
Kristina Pumphrey, PE, is an accomplished Process Engineer with more than 20 years of experience in the pharmaceutical and biopharmaceutical industries. Her broad knowledge base, spanning industry technologies, includes material handling, potent compounds, and hazard analysis. At Precis, Kristina is responsible for translating user requirements into a working facility by specifying the equipment, controls, and interconnecting piping into an efficient layout that meets cGMP and regulatory requirements and results in a quality product. A certified Lean Six Sigma Black Belt, Kristina uses her lean manufacturing expertise to help clients plan for the future by improving operational efficiency. She holds a Master of Science in Management and Technology from Widener University and a Bachelor of Science in Chemical Engineering from the Pennsylvania State University. She also extends her pharma industry leadership to the professional community as a member of the International Society of Pharmaceutical Engineering (ISPE).
Registration:
Please register no later than Thursday, May 19 at 12 noon. Cancellation requests received by the registration deadline will be fully refunded.
Should you have any further questions, please do not hesitate to reach out to Cynthia Tarun at tarun.aichedvs@gmail.com, 832-341-4960 (Mobile).