The PDA Australia Chapter are delighted to invite you to join our first event for 2021, a webinar on the Validation and Cycle Requirements for GMP Autoclaves.
Attendees will better understand the inspection process and the role of the internal stakeholders during an FDA inspection surrounding critical environments such as sterile environments and cleanrooms and cleaning process equipment/Cleaning Validation.
WHY SHOULD YOU ATTEND?
In this webinar, you will have a better understanding of:
- Steam sterilization on a microbial level.
- Autoclave Performance Qualification expectations.
- Regulatory and GMP requirements for steam sterilization.
- Process verification tools for use in an autoclave.
- Common questions, problems and cGMPs.
During the presentation Aaron will provide an overview of microbiology principles in steam sterilization and application, as well as autoclave Performance Qualification regulatory expectations and cGMPs.
The presentation will be concluded with a Q&A opportunity from the audience.
Aaron Mertens,
Technical Service Manager
STERIS Corporation
Brief Introduction of Aaron Mertens:
For over 20 years, Aaron has held several positions within the Pharmaceutical Industry, specializing in cleaning, disinfection, sterilization and contamination control in parenteral drug manufacturing.
In these roles, he has gained experience interfacing with industry regulatory agencies (FDA, EMEA, Japan), representing quality assurance programs. Aaron joined STERIS Life Sciences Contamination Control Solutions as a Technical Service Manager in January 2015 has been a member of various industry organizations (PDA, ISPE) since 1999, and is the current president of the ISPE Great Lakes Chapter.
09 Feb 2021 | 8-9.30pm (Malaysia Time) | Online
