Call us at +1-661-336-9555

cart

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.


  • 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

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.


  • QA Managers and Associates responsible for QC Oversight
  • QC Analyst and Manager
  • QA/QC/Compliance/Regulatory affairs professionals

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.

View all trainings by this speaker
 
Live Webinar

Live + Recorded Session

Get unlimited access to the link for six months for one participant, from the date of webinar completion.

$269

Live + Transcript

Get to attend the LIVE Session and also receive a PDF copy of the Transcript only after the completion of the LIVE webinar.

$249

Live + DVD/USB

Free shipment within 15 Working Days from the date of webinar completion.*

$450

On Demand

Transcript

PDF Transcript of the Training which are available once the webinar is completed.(Transcript for single user only)

$179

Downloadable Recorded Session

Get unlimited access to the link for six months.

$239

DVD/USB

Free shipment within 15 Working Days, from the date of webinar completion.*

$350

Group Session

Group Session Participants + Recorded

Live Session for 10 Participants (For adding extra attendees please contact our Customer Support Team)

$799

 

Upcoming Webinars