09:00 – 10:35 | P4: Manufacturing Investigations
Moderators: Marc Glogovsky, MS, SM (NRCM), Business Unit Manager/Senior Consultant - Microbiology, ValSource, Inc. and Christopher A. Murdock, PhD, CQA, Senior Director, Global Quality Systems, Bristol Myers Squibb
In this plenary session, the presenters will expand PDA TR88’s systematic manufacturing investigations approach and provide attendees with a roadmap to improve their contamination control strategy using a structured tool to deal with complex investigations following loss of environmental control in the cleanroom.
Beginning with “A Roadmap to a Successful Cleaning and Disinfection Program,” the key concerns in the industry related to their cleaning and disinfection program such as biocidal selection, cleaning frequency, wet contact time, fungal spore outbreaks, rotation, residues, and disinfectant validation will be discussed. Then, “The Restart Process as a Tool in Microbiological Manufacturing Investigations” will propose a structured approach to manage unplanned events which have led to a loss of environmental control, to set the process for driving the environment back to the controlled state, ensuring that the right subject matter experts are involved on the team and the needed tasks (e.g., cleaning and disinfection, EM) are performed sequentially and are satisfactory prior to resuming manufacturing.
09:00 | Welcome Back and Recap from Co-Chairs
09:15 | The Restart Process as a Tool in Microbiological Manufacturing Investigations
Dona B. Reber, MEd, SM (NCRM), Principal Consultant, AccurateMicrobiology.com
Francesco Boschi, Senior Manager Technical Services - Global Microbiology and Aseptic Support Team (MAS), Pfizer
09:45 | A Roadmap to a Successful Cleaning and Disinfection Program
10:15 | Q&A
James N. Polarine, Jr., MA, Senior Technical Service Manager, STERIS Corporation