Examining the FDA Guide to Inspections of Pharmaceutical Quality Control Laboratories
Key Requirements to Ensure Compliance, How to Defend Your Position During a Regulatory Audit and Understanding Key Inspection Differences in Quality Assurance vs. Quality Control

Live, Interactive Training Webinar

Date: Tuesday August 29, 2023

Time: 10:30 am - 12:30 pm ET (New York Time)

Instructor: Kim Huynh-Ba Biography>>>

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The Food and Drug Administration (FDA) conducts inspections and assessment of the Quality Control (QC) laboratories to determine if the organization comply with applicable law and regulations such as Good Manufacturing Practices (GMPs). The QC laboratory serves one of the most important pharmaceutical manufacturing and control functions because it provides analytical data and results of product release and stability studies according to the product registration to monitor product quality in the market. At the minimum, the QC laboratory should receive a comprehensive GMP evaluation every two years to maintain their obligation.

This instructor-led live training webinar will explain the essential functions of the quality control professional and discuss different types of audits and inspections. This live training session will also discuss critical areas from the FDA Guide to Inspection of Pharmaceutical Quality Control Laboratories that the laboratory personnel must know to ensure regulatory compliance and defend their positions during a regulatory inspection. This guide is an independent mechanism to ensure that the regulatory requirements of GMP are in place within either an internal or external laboratory and demonstrate the essential compliance elements. This should be part of any GMP training for the QC laboratories.

Learning Benefits:

  • Compare Quality Assurance vs. Quality Control.
  • Explain job functions and quality roles.
  • Discuss different types of quality inspections.
  • Understand expectations from the FDA Guide to Inspection of QC Lab.
  • Perform effective quality auditing techniques.
  • Understand performance-based quality systems.
  • Improving documentation practices on the validation.
  • Managing non-conformances, deviations, and complaints.
  • System to track OOS investigations and CAPA effectiveness.
  • Provide support to change management.

Webinar outline and time breakdown:

Time*

10:15 AM Log-In Period

10:30 AM Introduction

                Live Presentation Part 1

11:30 AM 10 Minute Break

                Live Presentation Part 2,

12:30 PMLive 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 training 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 and Development
  • Regulatory Affairs Professionals
  • Auditors
  • Validation

How to Attend:
All Pharma Webinars live training programs audio and visuals are delivered via Cisco WebEx with a basic system requirement of a computer with internet access. You do not require a Webex account to join Pharma Webinars’ live training courses, participants receive an email invitation that provides the access you need to join the meeting.

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 AstraZeneca (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>>>