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Aseptic Processing Overview and Validation 2019

: 28 Feb 2019

Sector: Clinical, Food & Beverage, Pharmaceutical, Water

Type: Conference, Training, Webinar

This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors.
Why should you Attend:
  • Learn the difference between Aseptic and Bulk processing
  • Understand facility and personnel requirements necessary to maintain microbial control
  • Learn basic principles of microbiology and microorganism recovery in relation to cleanroom environmental monitoring (EM) and impact to product
  • Understand the gowning requirements associated with different cleanroom classifications
Areas Covered in the Session:
  • Review clean area behaviors
  • Personnel gowning requirements
  • Good clean area behaviors/practices
  • Practices to avoid – and why
Who Will Benefit:
  • Engineering & Validation
  • Facilities / Maintenance
  • Quality Assurance
  • Regulatory Affairs
Speaker Profile:
Kelly 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.


Phone: +1-800-447-9407
Email: support@compliance4All.com
Visit: http://www.compliance4all.com/control/main

<< Previous article
Understanding Steril...
Next article > >
Auditing to Meet FDA...