Owner
Pure Microbiology
Abby Roth, founder of Pure Microbiology, has over 17 years of experience in supporting the testing and consulting needs of the pharmaceutical, medical device, and compounding industries. Her background in pharmaceutical microbiology includes extensive knowledge of environmental monitoring and product testing. Abby also has participated multiple microbial excursions investigations, providing guidance on contamination sources and remediation options.
Abby’s lab experience started in 2004 and continued through 2017, where she held the role of Quality Director at a contract pharmaceutical microbiology laboratory. To improve her quality knowledge base, she holds the Certified Manager of Quality/Organizational Excellence certification through the American Society of Quality.
Prior to founding Pure Microbiology in 2022, she was a subject matter expert for CriticalPoint LLC, a health care training and development company. In addition to operational responsibilities, she developed curriculum for educational sterile compounding products. Abby was also a consultant for Clinical IQ, serving as their Director of Microbiology.
Abby’s passion for sterile compounding started in 2008 when USP Chapter <797> introduced the requirement for viable air and surface sampling, but it really blossomed in 2015 when she had the honor of serving as an expert committee member for the USP Compounding Committee for the 2015 to 2020 cycle. She is an involved member of Controlled Environment Testing Association (CETA), speaking at their annual meetings and chairing committees for the revision of three CETA Application Guides. Abby has been invited to speak for state Boards of Pharmacy and national organizations.
I do not have any relevant financial / non-financial relationships with any proprietary interests.
Monday, March 14, 2022
9:45am – 10:45am CT
Tuesday, March 15, 2022
3:45pm – 4:45pm CT
