GMPs for Microbiologists: The Manufacturing Environment Webinar – ResearchAndMarkets.com
DUBLIN–(BUSINESS WIRE)–The “GMPs for MICROBIOLOGISTS – The Manufacturing Environment” webinar has been added to ResearchAndMarkets.com’s offering.
The objective of this webinar is to obtain an enhanced understanding as well as a “refresher” of what requirements exist for the microbiologist throughout the production environment from in-coming through final release.
Within a Manufacturing Environment, cGMP microbiological issues always arise that require addressing. Whether the facility is considered to be a Controlled or Classified environment, whether it is manufacturing non-sterile or aseptically filled product, the Microbiology Environment of the product is critical to assuring products leave the facility with the microbiology specifications in control.
As the facility is examined in additional detail, the environment also must be considered. Both airborne viable and non-viable particulate considerations must be explored and controlled within all areas from ISO 5 to 8. The water systems, which include potable water, purified water, and water for injection, will also be explored regarding their specifications, maintenance, and compliance.
A review of Case Studies/Warning Letters pertinent to all phases of the microbiologist’s environment will be reviewed to enhance the learning benefits. Please plan to attend this with an interdisciplinary team to share this information.
Webinar Takeaway
- To Gain an overall review of cGMP and those sections of 21 CFR 211 that impact microbiology within the Manufacturing environment
- Review USP, 21 CFR 211, EP, Canadian, ISO and various FDA Guidances that impact microbiological issues throughout the cGMP environment for the microbiologist within manufacturing/QC operations
- Determine how to control numbers/species of microorganisms within the manufacturing environment with disinfectants and antiseptics USP<1072>
- Review how to control water systems (PW/WFI) within a manufacturing environment
- Study how OOT, OOS and CAPAs impact all aspects of the microbiological environment
- Review various Case Studies that involve Form FDA 483s and Warning Letters
Who Should Attend:
- Quality Assurance
- Regulatory Compliance
- Quality Control
- Facilities
- Manufacturing
- Validation
- In-Coming Materials
- Project Managers
For more information about this webinar visit https://www.researchandmarkets.com/r/z67e1b
Contacts
ResearchAndMarkets.com
Laura Wood, Senior Press Manager
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