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Aseptic Processing Overview and Validation 2019


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Who should attend?

Engineering & Validation Facilities / Maintenance Quality Assurance Regulatory Affairs

Details

Overview:
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:
Explain the difference between Aseptic and Bulk processing
Understand facility and personnel requirements necessary to maintain
microbial control
Explain 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.

Event Fee: One Dial-in One Attendee Price: US $150.00

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: compliance4all14@gmail.com

Prices

One Dial-in One Attendee Price: $150.00

Contact

Event Manager
compliance4all14@gmail.com

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