The manufacture of aseptically produced sterile products represents the greatest level of risk to the public and as a result there are numerous requirements that companies must abide by for compliance. This training will cover not only the current regulations as set by the FDA but also those required by the European Union (EU) GMPs. This will include the main areas of focus by regulatory auditors, expectations for the qualification of equipment and utilities, along with environmental monitoring, media fills and personnel qualification to name a few.
As expected, training of both personnel and management is an increasing area of concern and this seminar will review some proposed reasons for operator error that regulators review to help determine other quality systems that may be impacted depending on the category to which operator error is associated with. Actual cases will be highlighted for some of the reasons listed.
Other critical aspects of this in-person training program:
Upon completing this course participants should:
This course is designed for people tasked with maintaining and improving 21 CFR 210-211, along with department personnel listed below:
For Registration - http://www.complianceonline.com/aseptic-processing-challenges-sterile-processes-sal-21-cfr-210-211-seminar-training-80289SEM-prdsm?channel=pickevent
Note: Use coupon code 232082 and get 10% off on registration.
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