Tuesday, November 16; 8:30am – 5:00pm
Ms. Kim Huynh-Ba, Pharmalytik Consulting, Newark, DE
Data Integrity has become the main focus in the pharmaceutical industry in the past few years. This course will cover key factors of Good Documentation Practices in the pharmaceutical industry such as Operational SOPs, analytical protocols, analytical reports. It will focus on streamlining the documentation process, identifying critical attributes to document technical information, establish human errors, and reduce potential documentation issues. Electronic records will also be part of the discussion. Participants should expect to share their experiences through interactive discussions and team exercises.
WHO SHOULD ATTEND
This course will benefit analytical chemists, staff scientists, supervisors, directors, investigators in QC lab, R&D, production, manufacturing, contract labs, quality assurance, regulatory affairs, laboratory auditors, lab inspectors, data reviewers, lab investigators. This course is not intended for microbiologists.
1. Good Documentation Practices and Principles of Data Integrity
a. Lab documentation
b. Structure of an SOP and Different types of SOPs
c. Handling deviations and compliance investigations
2. Establish a GMP Protocol
a. Structure of a protocol
b. Development information and Determine scope/purpose
c. Setting acceptance criteria
3. Put data together and write a GMP Report
a. Presenting data in a report
b. Evaluation of data and writing an executive summary
c. Tracking and maintaining references
4. Lifecycle GMP Document
a. Evaluate Human Error to establish process
b. Change Control Process
c. Lifecycle management of GMP document
ABOUT THE INSTRUCTOR:
Kim Huynh-Ba is the Managing Director of Pharmalytik LLC (www.pharmalytik.com) providing consulting and training for pharmaceutical companies, specializing in quality systems, analytical sciences, CMC, and stability sciences. Kim is a member of the Governing Board of EAS. She is a member of the USP’s Council of Experts for the 2020‐2025 cycle and the Chair of the Chemical Medicines Monographs 4 Expert Committee. She is also the Chair of USP Good Documentation Practices and a member of USP Organic Impurities Expert Panels. She is an adjunct professor at Temple University‐RAQA Program and Illinois Institute of Technology (IIT) teaching Pharmaceutical Analysis, Quality audit, ICH Quality Guidelines, and GMP regulations. Kim has authored over 80 technical publications and book chapters. Kim is a frequent speaker at national and international pharmaceutical conferences. She recently published the textbook entitled Analytical Chemistry-An introduction to the Pharmaceutical GMP Laboratory.