This course will educate you about various key elements of sterility assurance and contamination control such as Cleanroom Regulations, Classification, Sources, and types of particles, Design Requirements, Validation/Qualification, Operations, Environmental Monitoring Program requirements, Excursion investigations, Data Trending, Microbiological processes/methodology, Cleanroom cleaning/disinfection.
The types of micro-organisms, typical mitigation steps in ensuring 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.
The types of micro-organisms, typical mitigation steps in ensuring 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.
Kelly Thomas
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.
50+ new Excel features so far this decade
Mindful Communication:The Key to Meaningful Conversations i…
FMLA Compliance in 2025: A Comprehensive Guide & Strategies…
Excel - 10 Key Worksheet Functions to Skyrocket Your Produc…
Managing Toxic Employees: Strategies For Leaders To Effecti…
Hiring and Retaining Employees in this Crazy Economy
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Project Management for administrative professionals
Excel Power Skills: Master Functions, Formulas, and Macros …
Outlook - Master your Mailbox - Inbox Hero Inbox Zero
Copilot and HR: An Introduction for HR Professionals
California Meal and Rest Breaks: What You Don't Know Can Co…
Bootcamp for New Managers and Supervisors: Develop These Es…
Policy Pops: Navigating DEI in the 2025 Workplace: Strategi…
Emotional Intelligence: Mastering the Emotions of Great Lea…
How To Conduct An Internal Harassment And Bullying Investig…
How to Manage the Legal Landmine of the FMLA, ADA and Worke…
The Importance of the first 5 seconds when presenting
Managing Difficult Employee Conversations
Female to Female Hostility @Workplace: All you Need to Know
How to Write Effective Audit Observations: The Principles f…
FDA Proposes Framework to Advance Credibility of AI Models