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.
Surviving and Thriving Organizational Change and Loss: The …
Impact Assessment and Risk Management for Change Control
Excel Deep Dive: Advanced Tips & Techniques – A 3-hour Work…
How to Write Effective Audit Observations: The Principles f…
Coming Soon - New Minimum Salary Levels for Exempt Employee…
Marijuana: Compliance and Safety in the Workplace
FDA Regulation of Artificial Intelligence/ Machine Learning
Stressed Out: How to Handle Conflict, Difficult People and …
2025 Top Employment Regulations That Will Impact Employers!
How to Handle Workplace Conversations Around Politics and R…
Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud,…
How to Give Corrective Feedback: The CARE Model - Eliminati…
Improving Employee Engagement & Retention Through Stay Inte…
SOPs - How to Write Them to Satisfy those Inspectors
Why EBITDA Doesn't Spell Cash Flow and What Does
With Mandatory Paid Leave Gaining Ground Is It Time To Do A…
Marketing to Medicare or Medicaid Beneficiaries - What You …
Human Error Reduction Techniques for Floor Supervisors
Documenting Misconduct that Will Stand Up in Court
Trial Master File (TMF)/eTMF, & FDAs Draft Guidance for Ele…
Tattoos, hijabs, piercings, and pink hair: The challenges …
Project Management for Non-Project Managers - How to commun…
OSHA Requirements for Supervisors, Project Leaders & HR - W…
Humane Layoffs: How to Let People Go with Compassion and De…
Unlock Employee Loyalty: Stay Interviews Will Keep Them Eng…
Sunshine Act Reporting - Clarification for Clinical Research
FFIEC BSA/AML Examination Manual: What Compliance Officers …
Female to Female Hostility @Workplace: All you Need to Know
Onboarding is NOT Orientation - How to Improve the New Empl…
FDA Technology Modernization Action Plan (TMAP) and Impact …
Excel - Pivot Tables - The Key To Modern Data Analysis and …
Managing Toxic & Other Employees Who Have Attitude Issues
Building GMP Excellence: A Guide to Implementing Compliant …
Excel Power Skills: Master Functions, Formulas, and Macros …