2022 Annual Environmental Monitoring Training Program – A Practical Approach to Design, Qualification and Implementation of a Robust and Compliant Environmental Monitoring and Trending Program with Paula Peacos

Darius Pillsbury (Senior Consultant) and Stephen Langille (Senior Microbiology Consultant) Presentation: Are You Ready for Annex 1? Points to Consider When Doing an Annex 1 Self-Assessment — A Comprehensive Review of Annex 1 History, Revisions and the Latest Draft to Ensure Readiness for Annex 1 Compliance & Understanding Its Potential Global Regulatory Impact

Stephen Langille, Ph.D. (Senior Microbiology Consultant) Presentation — Burkholderia cepacia Complex Organisms: The New General Chapter USP <60> Microbiological Examination of Non-Sterile Products Tests for Burkholderia cepacia Complex & FDA’s Position on Bcc.

Scheduled December 7 at 10 am PRT/9 am EST, James Vesper a member of the VS consulting team, will be presenting “An Example of Using a Risk-Based Approach for Data Integrity.” His presentation will discuss: When do you “verify” an action? What does “verify” really mean? How does verify compare to actions like review or check? This presentation looks at what the US, EU, and PIC/S Good Manufacturing Practice regulations say about confirming that an action or activity has taken place using a risk-based approach that supports data integrity.

Tired of TEAMS? Zoomed-Out? ValSource’s Training Team is here to connect, face-to-face. You’re ready for real interactions, and we are too. Get to know colleagues, discuss important topics, and learn more – together.

Discover novel approaches and best practices for tackling current industry contamination control challenges at the 4th Annual SMi Pharmaceutical Microbiology West Coast (Virtual) Conference.

Ensure compliance when you transform your root cause analysis and corrective and preventive action (CAPA) investigations. Join James Vesper, Director, ValSource Learning Solutions, on a discussion exploring risk-based alternatives when a definitive root cause can’t be determined.

Learn ways to conduct better investigations and corrective actions. This workshop examines a defined, logical process that can be applied to investigations that are performed in the drug, biotech, and medical device industries.

Improving, Modernizing, Transforming – Process Validation Gets a (much needed) Upgrade