Panel Discussion on Recent ISPE Article on Visual Inspection for 503B's
Complimentary
Learning Level: Intermediate
Session Length: 1 hour
Visual inspection is nothing new to professionals who make, prescribe, prepare, and/or administer pharmaceutical parenteral products to patients of all backgrounds, especially those who may have immunity concerns. The pharmaceutical industry has tried to ensure that companies enact the best quality standards that are consistent with current Good Manufacturing Practices (cGMPs) to prevent an adulterated product from entering the market.
A good, solid, thorough Visual Inspection is paramount in ensuring product & patient safety. Compounding companies are required to ensure to that their processes provide an aseptic and cGMP environment that will reduce and/or eliminate potential product contamination via particulates. Visual Inspection, whether through an automated or manual process, must be a vigorous process to ensure patients receive products that will help them in all facets of their immediate health issues. Most compounding companies utilize a manual driven visual inspection process and our webinar will focus on that aspect of visual inspection.
Our presentation will be a panel session where a moderator will ask questions around the recent ISPE article on Visual Inspection titled "Visual Inspection Is Key to Ensuring Patient Safety in US Pharmaceutical Compounded Products." (ISPE Magazine: July/August 2025)
Our Panelists are: Christopher Smalley, Deborah McHugh, Kathleen Kane, and David Short.
Our Moderator is: Rebecca Welton.
Learning Objectives
- The importance of ensuring a robust manual inspection visual inspection process.
- The importance of including Acceptable Quality Limit (AQL) as part of the visual inspection process.
- The importance of implementing and/or enhancing a robust training and qualification program related to the visual inspection process.
Speakers
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