Managing your GMP Quality Control (QC) Labs in Compliance with FDA Regulations
Instructor:
Kim Huynh-Ba
Product ID: 705081
- Duration: 90 Min
Why Should You Attend:
New medicines are developed every day to meet medical needs and improve quality of life. Pharmaceutical companies spend a lucrative average of between 800 million to 1.2 billion dollars in R&D to bring a new drug to market. The analytical development program plays a critical role in the pharmaceutical industry, where much effort is spent on developing testing procedures to ensure quality, safety and efficacy of new drug product.
This webinar will discuss compliance and validation issues that typically found with pharmaceutical QC labs. Observations regarding GMP violations and issues on compliance and validation will be discussed.
Areas Covered in the Webinar:
- Current Drug Development Process
- Regulatory Requirements for pharmaceutical laboratories
- Lab Controls requirements from cGMPs
- Discuss warning letters effecting the analytical labs
- Review GMP requirements related to the analytical labs
- Understand quality systems to support the analytical functions
Who Will Benefit:
- R&D analysts
- QA and QC Managers
- Regulatory scientists
- Directors
- Manufacturers
- Laboratory managers
- Regulatory affairs
Kim Huynh-Ba
Founder and Technical Director, Pharmalytik
Kim Huynh-Ba is the Executive Director and CEO of Pharmalytik (www.pharmalytik.com), where she provides consulting and training services to pharmaceutical companies, including companies operating under FDA’s Consent Decree. She is the editor of the well known “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices” and “Pharmaceutical Stability Testing to Support Global Markets” (2010). She has over 25 years of experience in analytical development, project management, strategic drug development and stability sciences. Prior to Pharmalytik, she was the Director of USP Pharmacopeial Education Department, where she was responsible for their education programs worldwide.
Kim is a member of the USP Council of Experts for the 2015-2020 cycle and is the Chair the Chemical Medicines IV Expert Committee. She is also the Chair of USP Good Documentation Practices Expert Panel and a member of USP Impurities of Drug Products Expert Panel. Kim is a member of the Governing Board of Eastern Analytical Symposium (EAS) and was their 2013 President.
She is an Adjunct Professor at Temple University-School of Pharmacy, Widener University and Illinois Institute of Technology (IIT) teaching pharmaceutical analysis, quality audit and GMPs graduate courses. Kim is also a short course instructor on numerous cGMP compliance and quality topics for several global organizations such as American Chemical Society (ACS), American Association of Pharmaceutical Scientists (AAPS), Pittsburgh Conference, U.S. Pharmacopeia (USP) and many other international training groups.
More Training By Experts
- Design Validation Protocol and Acceptance Criteria for Chromatographic Methods to Meet ICH Requirements
- Stability Program to Support Shipping and Distribution of Drug Products
- To Validate or Not To Validate: A Daily Question for the Pharmaceutical Scientist
- Establish Change Control for Pharmaceutical Stability Program
- GMP Requirements for Validation and Re-Validation of Analytical Procedures
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