WHO Good Manufacturing Practices (GMPs): Understanding WHO Inspection Requirements

Live, Interactive Training Webinar

Date: Wednesday October 26, 2016 - Time: 9:30 AM - 11:30 AM ET
Instructor: Kim Huynh-Ba Biography>>>

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Compliance with Good Manufacturing Practices (GMPs) is important to every companies that develop and manufacturing pharmaceutical products. An effective inspection process will help management to determine the weak areas and provide additional resources, oversights or governance. It is also help the organization to be more effective during external audits and inspections. By determining GMP issues and taking action, a company would be more proactive to strive for better quality systems and ensure that the company is operating in a state of control while meeting cGMP compliance expectations..

However, the number of pharmaceutical companies that have received quality observations indicating that management oversight of cGMP compliance is a significant and continuing problem in the industry. These become detrimental issues resulting with tarnished reputations, loss of brand loyalty, stockholder lawsuits, and unprecedented financial impact. In many cases, the warning signals were undetected, unheeded, or rationalized away.

This live interactive session will explore the inspection process. Understand the system is essential to the design and control of a robust process to handle internal and external inspection.

Learning Benefits:
- Understand Principles of Quality Management System.
- Discuss WHO expectation of an inspection process.
- Discuss requirements for documentation and records.
- Determine critical issues via risk management concepts.
- Establish CAPA systems for continuous improvement.
- Discuss the structure of an inspection report.
- Maintain compliance throughout product lifecycle.

Webinar outline and time breakdown:

Time*
9:15 AM Log In Period
9:30 AM Introduction
9:40 AM Understand Principles of Quality Management System,
Discuss WHO expectation of an inspection process,
Discuss requirements for documentation and records,
Determine critical issues via risk management concepts,
10:30 AM Break
10:40 AM Establish CAPA systems for continuous improvement,
Discuss the structure of an inspection report,
Maintain compliance throughout product lifecycle,
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
  • Validation
  • Auditor Professionals
  • Research & Development

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Instructor: Kim Huynh-Ba

Kim has almost 25 years of experience in analytical development, project management, strategic drug development and stability sciences. Prior to Pharmalytik, she held technical positions in drug development at Astra Zeneca (formerly ICI Americas), DuPont Merck, DuPont Pharmaceuticals, Bristol Myers Squibb and Wyeth Vaccines. Her experiences range from analytical development to supporting CMC activities of multiple regulatory submissions, addressing regulatory responses to observations or investigations, or developing stability submission strategies.

She is an Adjunct Professor at Temple University-School of Pharmacy, Illinois Institute of Technology and Widener University. Kim currently is a member of United States Pharmacopeia (USP) General Chapter Expert Committee (2010-2015) and USP’s Reference Standard Project Team (2009-2010). She is also a member of the CHPA’s Impurities Breakout Group. She is chair of AAPS APQ Distance Learning and organized several APQ Open Forums. She serves on the Executive Committee of Governing Board of Eastern Analytical Symposium (EAS). She is the editor of the “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices” published in 11/2008, and also “Pharmaceutical Stability Testing to Support Global Markets” published in 01/2010… 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