2024 PDA Sponsored Workshop - Environmental Monitoring: Science-based Decision Making

Environmental surveillance assesses the effectiveness of the manufacturing site controls. Environmental monitoring (EM) of cleanrooms and controlled environments serve as an adjunct to the sterility assurance program for microbial quality of drugs. A robust EM program considers technical fundamentals and a risk-based approach. However, there is no prescriptive approach, and the various forms of guidance available often leave room for a degree of flexibility, which sometimes can be ambiguous. A plethora of decisions which must be considered are often taken for granted, such as where and how often to monitor, what samples to take, what culture medias to use, single/dual incubations, how to interpret data, and which identifications to perform.

This workshop will center on Technical Report (TR) 13: Fundamentals on an EM program and will also examine interactive case studies shared by our subject matter experts.

During the workshop you'll learn:

• The application of current regulatory guidance
• Risk assessments to support EM program
• EMPQ creation and execution
• Routine room re-certification as per Annex 1
• A holistic approach to solving EM excursions
• How to continuously improve your EM program

The 2024 PDA Pharmaceutical Manufacturing & Quality Conference is an in-person event that will be held on 7 - 8 May 2024 at Orchard Hotel, Singapore. This year we are bringing you a whole new program focusing on the theme "Future Landscape in Pharma: Bridging Innnovations for Sustainable Compliance".

Sign Up For Main Conference Here!

• PDA 102.3 Technical Report No. 13: Fundamentals of an Environmental Monitoring Program​
• PDA 612 Analysis of Environmental Monitoring Data with Respect to cGMP and Data Integrity Guidelines​
• PDA 620 Technical Report No. 88 Microbial Data Deviation Investigations in the Pharmaceutical Industry​
• PDA 612.1 Analysis of Environmental Monitoring Data with Respect to cGMP and Data Integrity Guidelines​
• PDA 102.3 Technical Report No. 13: Fundamentals of an Environmental Monitoring Program​

• PDA Technical Report No. 13 Revised 2022 (TR 13) Fundamentals of an Environmental Monitoring Program (single user digital version)​