This webinar will concentrate on the key attributes of an effective cGMP investigation, the role of management, quality control tools, CAPA effectiveness and Warning Letters associated with cGMP compliance. Attend this training and learn how you can avoid “Inadequate investigations”
“Any unexplained discrepancy or the failure of a batch or any of its components to meet any of its specifications shall be thoroughly investigated. A written record of the investigation shall be made and shall include the conclusions and follow-up.”
Implementing an effective system of conducting investigations that, ensure compliance of the five manufacturing systems: production, facilities and equipment, laboratory controls, materials, packaging and labeling and the overarching quality system is a critical requirement for the manufacture and sale of all FDA regulated products.
WHY SHOULD YOU ATTEND
Any FDA inspection will ask to review your complaints, investigations and recalls. This, with a tour will be their first impression of your organization’s state of compliance. The investigations you performed for unexplained discrepancies and complaints will need to stand alone for an inspector to read and understand. They can and will ask questions for clarification but minimizing the number will not sidetrack their focus.
In a list of top ten reasons for FDA form 483s, investigations discrepancies, failures were number two.
Effective and repeatable failure investigation and root cause analysis is still not the industry norm.
This webinar will discuss the keys to an effective cGMP investigation, the role of management, employing quality tools, root cause determination and CAPA effectiveness checks.
Unexplained discrepancies and failures will occur; effective investigations and CAPAs ensure they do not reoccur.
This webinar will give you a process to establish an effective system of conducting investigations. This includes:
WHO WILL BENEFIT
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