Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers
Instructor:
Kelly Thomas
Product ID: 706927
- Duration: 90 Min
Why Should You Attend:
The types of micro-organisms, typical mitigation steps in ensuring an effective contamination control through Personnel Training (Aseptic Practices, Cleanroom Behavior, and Contamination Control Procedures), Gowning Controls, Personnel Training, Cleanroom Trafficking (Cleanroom Personnel Material, Product and Equipment Transfer Practices and Training (Entry and Exit Policy), Cleanroom Gowning, Contamination Control, Cleaning, and Disinfection Program and the Basics of Sterilization Processes- Physical and Chemical Processes will also be discussed.
The various regulatory bodies’ requirements such as 21 CFR Part 211 (mostly relevant 211.113 “Control of microbiological contamination”, ISO 14644 (Various Parts), FDA Guidance for Industry: Sterile Drug Products Produced By Aseptic Processing - Current Good Manufacturing Practice”) amongst others and the criticality of aseptic processing and other key contamination control evaluators during the manufacture and testing of products are important to the quality determination and release of the finished manufactured products.
Areas Covered in the Webinar:
- Cleanroom Regulations, Classifications, Basic Background, and Design Considerations
- Cleanroom Qualification, Cleaning Validation (IOQ/PQ), Routine Monitoring and Excursion Investigation
- Environmental Monitoring Program (Monitoring, Excursion Investigation and Trending of Data)
- Personnel Training (Aseptic Practices, Cleanroom Behavior, and Contamination Control Procedures)
- Cleanroom Trafficking (Cleanroom Personnel Material, Product and Equipment Transfer Practices and Training (Entry and Exit Policy)
- Cleanroom Gowning, Contamination Control, Cleaning, and Disinfection Program, Basics of Sterilization Processes- Physical and Chemical Processes
Who Will Benefit:
- QA Managers and Associates responsible for QC Oversight
- QC Analyst and Manager
- QA/QC/Compliance/Regulatory affairs professionals
Kelly Thomas
Vice President, Americas Quality Operations
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.
Utilizing strategic thinking, risk-based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.
More Training By Experts
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- ASTM 2500: Lessons Learned Through a Decade of Implementation
- How to Write Effective 483 and Warning Letter Responses
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
