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

Date: Thursday March 14, 2019 - Time: 9:30 AM - 11:30 AM (Eastern New York Time)
Instructor: Kim Huynh-Ba Biography>>>

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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.

Learning Benefits:
-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*
09:15 AM Log In Period
09:30 AM Introduction
09:40 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,
10:30 AM Break
10:40 AM Determine follow up actions and CAPA,
Change control process,
Overview of the complaint and recall programs,
11:30 AM 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
  • Validation
  • Auditors
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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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Client Testimonials:

"The live webinar was very useful to our team, the content was relevant and the instructor was very knowledgeable" QC Microbiology Supervisor, NJ

"We were very satisfied with the live presentation; we appreciated the speaker staying on to answer all of our questions" QA Director, MA

"Our group enjoyed the live presentation and found the experience much more engaging and worthwhile than any recorded webcasts" Sr Training Manager, CA

"This was my first live training, I found it easy to connect, participate and very useful" Laboratory Analyst, PA

"We had our entire department attend this training program and found it to be very useful, I am very satisfied with the speaker's ability to keep the audience engaged" QC Manager, NY

"Given how recent the content of the webinar was, our team members were very happy with the relevance of the training" VP Clinical Operations, CA

"Is my first time to attend training, I enjoy it very much" Sr Manager, Korea

"Our department found the level of interactivity between the audience and the instructor far beyond that of any other online training that we have attended before. Well done" Director Regulatory Affairs, ON

"Our interest group was spread out over three locations and we were able to participate simultaneously and interact very easily" Lead Compliance Manager, IL

"Well satisfied with the presentation. Our team found the speaker's level of knowledge and his ability to translate that knowledge to our processes very valuable" VP Quality Operations, NC

"We were impressed with the quality of the presentation, and despite our being located in Europe we were able to participate without a hitch" QC Manager, Ireland