Quality Management System (QMS) – Handling Deviations and Out-of-Spec (OOS) Investigations Based on the Latest FDA, EMA and Global Regulatory Requirements
Live, Interactive Training Webinar
Available Live On-Demand
Instructor: Kim Huynh-Ba Biography>>>
Available Live On-Demand
Quality Management System (QMS) will ensure that the quality for drug product is maintained throughout its expiration dating. In this part of the GMP live training series, we will discuss how to handle issues when things are not going as expected. Inadequate documentation of incidents and investigation of deviations or Out-of-Specifications continue to be the major part of Warning Letters. Key challenges for many companies are having a clear understanding of regulatory expectations on how to handle OOS investigations. Lack of consistency and ineffective root-cause analysis will lead to error and expensive laboratory activities. This session will discuss the Guidance for Industry on OOS/OOT Investigation and industry best practices of investigation process, and how CAPA can be determined.
In addition, this live session will also introduce other monitoring system such as the complaint and recall programs. In order to maintain QMS, the change control program must also be established to ensure that the manufacturing and testing of the product is maintained in the compliance state.
-Understand regulatory expectations for OOS investigation.
-Build ruggedness into analytical procedures to prevent OOS occurrences.
-Building compliance into the investigation process and minimize OOS.
-Discuss the Complaint/Recall programs.
-Understand key issues of Change Control program.
-Define and monitor Corrective and Preventive Actions.
Webinar outline and time breakdown:Time*
|10:15 AM||Log In Period|
|10:40 AM||Understand regulatory expectations of reporting deviations,|
|Review of warning letters related to OOS/OOT,|
|OOS investigation process,|
|Phase I: Laboratory Investigation,|
|Phase II: Full Scale OOS Investigation,|
|Conclusion and Documentation,|
|11:40 AM||Determine follow up actions and CAPA,|
|Change control process,|
|Overview of the complaint and recall programs,|
|12:30 PM||Live Questions & Discussion|
*Please note all times are Eastern Time (New York Time)
This live training webinar includes the following for each registered attendee:
- A copy of the presentation slides
- A certificate of participation for attendee training records
Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:
- Quality Assurance personnel
- Quality Control personnel
- Research & Development
- Regulatory Affairs Professionals
Instructor: Peter Calcott Ph.D.
Peter H. Calcott, Ph.D. is President, Calcott Consulting which is focused on delivering solutions to pharmaceutical and biotechnology companies in the areas of corporate strategy, supply chain, quality, clinical development, regulatory affairs, corporate compliance and enterprise e-solutions. He is also an Academic Program Developer for the University of California, Berkeley’s Biotechnology and Pharmaceutics Postgraduate Programs. Prior to this he was VP at the executive team level at PDL BioPharma where he was responsible for development and implementation of Quality & Compliance strategy across the corporation… Full Bio>>>
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