Regulatory Aspects of Microbiology in a Non-Sterile Environment
: 16 Jan 2020
Type: Training, Webinar
This live interactive training webinar will consider regulatory aspects of microbiology in a non-sterile environment including understanding the FDA regulatory requirements & USP non-sterile documents pertaining to non-sterile manufacturing.
- Review the various regulations pertaining to non-sterile raw materials, in-process materials, and final product.
- Examine the various USP documents that pertain to the concept of non-sterile manufacturing.
- Gather information regarding the impact of process hold times, preservation issues, cleaning, sanitization, and the requirements for the testing of recovered microorganisms.
- Learn when recovered microorganisms require testing.
- Understand why warning letters and recalls were issued for non-sterility.