Sterility Assurance in Healthcare Compounding
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The PDA Midwest Chapter is pleased to present two speakers for our December 2022 event to focus on Sterility Assurance in Healthcare Compounding.
- “State of Control” as applied to Healthcare Compounding.
Presented by Willis C. Triplett, Pharm.D.
This presentation will focus on the differences between the language of the USP Compounding Standards versus the FDA’s application of federal requirements to healthcare compounding entities, especially their Guidances on Insanitary Conditions (2020) and CGMP Guidance for Human Drug Compounding Outsourcing Facilities (2020).
The presentation will include:
- Updates to USP Compounding Standards published November 1, 2022
- “Two Masters” – the role of state professional boards versus FDA
- Evolution of the QA approach in healthcare compounding and the need to improve it for large-batch compounding
- The Outsourcing Sector’s reality contrasted to its expectations
- The need for mentorship – FDA’s “Center of Excellence,” PDA and ISPE.
- Sterility Assurance in 503A and 503B Compounding Facilities
Presented by Richard Van Doel, MS, PhD
Sterility cannot be demonstrated without the destructive testing of every sterile unit. In a real sense, microbiological safety is achieved through the implementation of interrelated controls that in combination provide confidence that the items are suitable for use as labeled. It is the controls that provide the desired assurance from microbiological risk rather than the results of any in-process or finished goods testing. <USP 1211>
The presentation will focus on design, operation, process controls, and monitoring systems necessary to support confidence in the facilities ability to produce sterile products.
Presentation Date and Time
Thursday, December 15, 2022 @ 12:00 pm (central time zone)
|Opening, Presenter Introduction||12:00pm – 12:10pm*|
Speaker – Willis C. Triplett, Pharm.D
|12:10pm – 12:40pm*|
|Speaker –Rick Van Doel, MS, PhD||12:40pm – 1:10pm|
|Q&A From Audience to Presenters||1:10pm – 1:30pm*|
|*Central time zone|
Willis C. Triplett, received his Bachelors in Pharmacy from The Ohio State University and his Doctor of pharmacy from the Philadelphia College of Pharmacy and Science. He started the first home infusion company in Indiana but after its sale, he turned to consulting and advising compounding pharmacies on all aspects of operations, but always with a special focus on compounding sterile preparations. After the Fungal Meningitis Outbreak in 2012, he turned his attention to studying the requirements of cGMP and formulating a compliance approach to help pharmacy compounders adapt to FDA inspections. He publishes a newsletter (FDA-Rx) that highlights FDA inspections of 503A and 503B entities and is devoted to convincing healthcare compounders to embrace statistical quality assurance.
Richard Van Doel, served as Performance Validation’s President/CEO from 2006 through 2021. He is a Certified Quality Auditor (ASQ). He has a BS Business Management, a MS in Strategic Management and PhD in Organizational Leadership from Indiana Wesleyan University. Professionally, Richard has provided services to the pharmaceutical and medical device manufacturing industries with positions of increasing responsibility for nearly 30 years. He has assisted medical device manufacturers in FDA remediation, developed compliant but right-sized validation programs, assisted in the development of quality systems that meet ISO 13485 and USFDA Quality Systems Regulations, and assisted the Pharmacy industry in meeting cGMP regulations for FDA registered Outsourcing Facilities. Richard was a previous chair of the Indianapolis Section of American Society of Quality, and the recording secretary of the ASTM E55 Committee E55 on Manufacture of Pharmaceutical and Biopharmaceutical Products
Thanks to our sponsor, general admission is FREE
Click the link below to register for this event
The PDA Midwest Chapter is very grateful to our dedicated members and sponsors for their continued interest, participation and support. We truly appreciate the generosity of our sponsors over the years, for without you, we could not provide this level of activity for our members.
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