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.
Handbook Overhaul 2026: Compliance, OBBB Act & Beyond
Fostering a Culture of Respect: Eliminating Gossip, Rumour…
Excel Spreadsheets; Develop and Validate for 21 CFR Part 11…
Paying and Receiving Payments for Referrals: You Can Go to …
Tattoos, hijabs, piercings, and pink hair: The challenges …
Ten Red Flags that Signal Financial Distress in Business Cu…
Excel + AI: The Smart User's Guide to Faster, Easier Work w…
The Age-Inclusive Workplace: How to Lead and Work Across Ge…
The Importance of the first 5 seconds when presenting
The New W4 - How to Assist Employees with Proper Completion…
Transforming Anger And Conflict Into Collaborative Problem …
4-Hour Virtual Seminar on Management Skills For New Managers
Microsoft Excel PivotTables: Basics of Data Analysis for Bu…
Supervisor Excellence: Skills to Lead High-Performing Teams
Tools for New Managers: Connecting with Employees to Optimi…
Fatal Errors Employers Make When Updating Employee Handbook…
The Manager’s Playbook for Leading After Layoffs: Quickly R…
Conquer Toxic People - Learn To Protect Yourself And Get Yo…
Elevate Your Workplace Wellness: 10 Critical Wellness Facto…
Thriving in a Hybrid Workplace: Keys to Leadership and Team…
Excel - Lists and Tables - A Beginner's Guide to Managing L…
Launch Your Career: The Ultimate Guide for Emerging Profess…
Mastering Performance Management: Strategies for Continuous…
Pivot tables beginner to advanced + 20 advanced Pivot table…
Gossip-Free: Leadership Techniques to Quell Office Chatter
Strategic ways to build your professional brand
Rewiring Your Emotional Triggers: Leading with Clarity and …
AI Fundamentals for All Leaders and Managers: How to Work S…
The $1M Mistake: EEOC Discrimination Claims Employers Make …
ChatGPT Jumpstart From intro to Download to Personal Assist…
Using Claude in Excel for Productivity, Automation & Data A…
2-Hour Virtual Seminar on the 6 Most Common Problems in FDA…
Do's and Don'ts of Documenting Employee Behaviour, Performa…
Why EBITDA Doesn't Spell Cash Flow and What Does?
HIPAA Compliance in 2026 — Practical Strategies for Breach …
FDA Regulation of Artificial Intelligence/ Machine Learning
How to Write Procedures to Avoid Human Errors
Secrets Of Psychology - Why People Do The Things They Do
AI in B2B Marketing: What Your Compliance Team Needs to Know