3rd Annual Cincinnati Educational and Networking Event

Joanne Barrick of Eli Lilly will be presenting on “Process Validation Lifecycle Implementation Update – Progress, Application to New Product Types and Available Tools”. This presentation will summarize learnings for the June ISPE PV for Bioproducts – Current and Next Generation conference including benchmarking data from participants and interactive workshop topic output. Participants in the Great Lakes Chapter meeting will also be asked to respond to some of the same benchmarking questions from the conference. The talk will also cover an overview of the ISPE’s recently published PV Good Practice Guide – including facilitation tools available in the Guide. There will be time for interactive discussion on current practices so please bring questions!

Michael Rutherford of Syneos Health will present on "Current Trends and Guidance on Data Integrity for Manufacturing Records." This presentation will look at how Data Integrity continues to be a focus of regulatory agencies around the globe. This presentation will provide a brief update on current trends and expectations, including an overview of the latest ISPE GAMP Records and Data Integrity Good Practice Guide on Data Integrity – Manufacturing Records, published 21 May 2019.

Elizabeth Rivera from Steris will present "Cleaning Agent Screening: Key Aspects in Selecting a Suitable Cleaning Agent for GMP Cleaning Procedures." The recent shift from traditional cleaning validation to a cleaning life cycle approach emphasizes the requirement for scientifically sound decisions in the design, qualification, and monitoring of a cleaning process (United States Food and Drug Administration, Pluta, 2009; LeBlanc, 2009; PDA TR29, 2012; Lopolito/Rivera 2014). Cleaning agent screening is a critical element of the cleaning life cycle approach and the right decision during the design phase can bring significant rewards during the qualification and monitoring stages. Cleaning agent selection is often based on historical practices; manufacturing Site A, uses cleaning agent X, therefore Site B, uses cleaning agent X. This approach is ideal if Site A and B are manufacturing the same product, on the same equipment, and have already successfully already transitioned their cleaning validation program to the life cycle model. If the original cleaning agent selection was made without scientific scrutiny then it could drastically increase cost of compliance and risk to the manufacturing process. This presentation will review different factors to consider in screening a cleaning agent based on a scientific, risk based approach. Some topics to be discussed are: chemistry, performance, rinsability, toxicity, environmental impact, safety, stability, among others.