Investigating Out of Specification (OOS)Test Results

February 23, 2023 | 10:15 – 5:15PM

BREAKING NEWS: FDA updates testing principles in their final OOS guidance (May 2022). The time has never been greater to stay up-to-speed with current regulatory thinking. With this release,  it is critical to unpack what this means for you and your organization. In addition, FDA, ICH and USP all recognize OOS as top priority in the drug development process, and each have respective guidance, albeit interpretation is left to industry. This training gives you up-to-the-minute insight into new regulations and industry trends and showcases how leading companies investigates and documents OOS test results.

Delivered by Industry’s Leading SMEs in the QC Laboratory Environment Covering:

  • Unpack FDA’s Investigating OOS Test Results for Pharmaceutical Production (May ’22) – Understand What This Means for You
  • Develop a Science-Based and Risk-Based Investigation Plan to Assess Test Results
  • Document An OOS Investigation to Meet Regulatory Expectations – Trials and Tribulations
  • Conduct a Root Cause Analysis and Establish CAPA to Avoid Regulatory Violations
  • Master the Responsibilities of the Analyst to Achieve Accurate Laboratory Test Results
  • Understand the Responsibilities of the Laboratory Supervisor
  • Examine the Raw Data and Verify the Calculations
  • Evaluate the Performance of the Test Method
  • Understand the Art of Retesting and Resampling
  • Learn Tips to Reduce and OOS and OOT Test Results

This event is also appropriate to business development and sales managers that offer innovative solutions for QC laboratory management, validation departments, data collection and statistics.


Personnel in the Following Environments Should Attend:

QA/QC

Scientist

Chemist

Laboratory Management

Validation

Regulatory Affairs

Data Integrity

 


FACULTY


Kim Huynh-Ba

Executive Director, Pharmalytik


Kim Huynh-Ba is the Managing Director of Pharmalytik, LLC, a consulting and training organization. She has almost 30-year experience in the Quality system, strategic drug development, and stability sciences.  She is a Council of Experts of US Pharmacopeia (2015-2020), where she chairs the Chemical Medicines IV Expert Committee. She is also a member of the USP Organic Impurities of Drug Products Expert Panel. Kim was the chair of the USP Good Documentation Practices Expert panel. Kim is an Adjunct Professor at Temple University-School of Pharmacy and Illinois Institute of Technology, where she teaches Quality Audit, GMPs, ICH quality guidelines, and Pharmaceutical Analysis. She is the editor of the two well-known stability handbooks- “Handbook of Stability Testing of Pharmaceutical products” and “Stability Testing to Support Global Markets.” She is also completing a new manuscript entitled “Analytical chemistry: A handbook of Pharmaceutical GMP Laboratories.”


Ronald D. Snee, Ph.D

Founder And President, Snee Associates, LLC


Ron Snee is Founder of Snee Associates, LLC, a firm dedicated to the successful implementation of process and organizational improvement initiatives, using Quality by Design, Lean Six Sigma and other improvement approaches. He is also an Adjunct Professor in the RAQA and pharmaceutical programs at Temple and Rutgers Universities. Prior to entering the consulting field he worked at DuPont for 24 years in a variety of assignments including pharmaceutical development. He has published eight books and more than 330 articles, 60 of which has appeared in the pharma and biotech literature. He is an Honorary Member of the American Society for Quality and has received numerous honors and awards for his research, consulting and publications.


Jane Weitzel

USP Council of Experts Member & Chair of the 2020-2025 General Chapters–Measurement and Data Quality

US Pharmacopeia


Jane was elected to the USP Council of Experts as member of the USP Council of Experts and chair of the 2020-2025 General Chapters–Measurement and Data Quality Expert Committee. She was a member of the USP 2015-2020 Statistics Expert Committee and member of the USP Expert Panel on Method Validation. She has been Director of pharmaceutical Quality Control laboratories. She has experience with many different regulatory environments.


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