Cleaning and Disinfection in Sterile Drug Manufacturing

With the release of EU Annex 1 in August of 2023, additional importance has been placed on having a coherent, justified contamination control strategy (CCS), including cleaning and disinfection. Consider every aspect of a comprehensive cleaning and disinfection program and how it may apply to an operation.

Register Free: https://www.pharmtech.com/pt_w/cleaning-and-disinfection

Event Overview:

Cleaning and disinfection are an integral part of a sterile drug facility’s contamination control strategy. Each process and cleanroom are different and there is no “one size fits all” program for cleaning and disinfection, which mitigates the inevitable ingress of contamination into critical areas. Focus topics for this webinar include:

• Regulatory expectations (including 2023 EU Annex 1).
• Evaluating and validating chemistries.
• Application methods.
• Risk-based determination of frequency, methodology, chemistry, and cleaning.

Key Learning Objectives:

• Understand different chemistries.
• Discuss regulatory expectations.
• Learn about the basic design of a cleaning and disinfection program.

Who Should Attend:

• Operations
• QC Micro
• Validation Group (if they own disinfectant efficacy)

Speaker:

Brent Watkins
SCMD Technical Manager
Veltek Associates, Inc.

Brent Watkins is Southeast Territory and SCMD Technical Manager for Veltek Associates, Inc., and has almost 30 years of experience in the pharmaceutical industry. Beginning his career in the pharmaceutical industry with Abbott Labs, he held various manufacturing positions as a part of the small volume parenteral operation at the Rocky Mount, NC facility. At Veltek, Brent is responsible for the southeast region as well as global technical support for sterile chemistries. In 2007, Brent joined the PDA Education faculty and has taught a variety of contamination control topics at the PDA Training and Research Institute, FDA, and on-site for clients. For his efforts, Brent is a two-time recipient of the James P. Agalloco Award for Excellence in Education (2014 and 2022). In addition to his responsibilities with PDA Education, he also participated in the task force to develop Technical Report 70 on Cleaning and Disinfection and is Vice Chair of the Education Advisory Board. Brent earned his bachelor’s degree in chemistry from Wake Forest University.

Register Free: https://www.pharmtech.com/pt_w/cleaning-and-disinfection