Date :
Place : United States, Fremont
Contact Person:Event Manager
Description:
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: [email protected]Deadline for abstracts/proposals : 26th February 2019
Organized By :Netzealous LLC DBA - Compliance4All
Keynote Speakers :
Venue :Fremont, CA, USA
Check the event website for more details.