E20-14: Communicating Analytical Results in the Pharmaceutical Labs and Maintaining Data Integrity with Good Documentation Practices (GDP)

Sunday, Nov. 1 – Monday, Nov. 2; 10:00am – 2:30pm

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 and identifying critical attributes to document technical information. Electronic records will also be part of the discussion.  Participants should expect to share their experiences through interactive discussions and team exercises

This one-day course will benefit analytical chemists, staff scientists, investigators in QC lab, managers, supervisors, directors, 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. Original document, controlled and uncontrolled copy
   b. Change control process
   c. Record retention schedule
   d. Lifecycle management of GMP document

Ms. Kim Huynh-Ba has over 25 years of experience in analytical strategic drug development and stability sciences. She is the Executive Director and CEO of Pharmalytik LLC (www.pharmalytik.com), where she provides consulting and training services to pharmaceutical companies since 2003. Kim is a member of the USP Council of Experts (2015-2020), where she chairs the Chemical Medicines IV Expert Committee. She is also a member of the Impurities of Drug Products Expert Panel and Food Adulteration Expert Panel. She 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 (IIT) teaching Pharmaceutical Analysis, GMP, QMS and Quality Audit graduate courses. She is also a short course instructor on cGMP compliance and quality topics for several global organizations such as American Chemical Society (ACS), American Association of Pharmaceutical Scientists (AAPS), Pittsburgh Conference, and many other international training groups. Kim is an active member of AAPS and the Alternate Councilor of ACS-Delaware. She is a member of the Executive Committee of Governing Board of Eastern Analytical Symposium (EAS) and was their 2013 President.

Kim has authored numerous technical publications, book chapters and has spoken extensively, both domestic and internationally, in the compliance and quality areas. She is the editor of 2 well-known Stability books: the “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices” (2008) and “Pharmaceutical Stability Testing to Support Global Markets” (2010). She is also working on a manuscript for the “Analytical Chemistry: An Introduction to Pharmaceutical GMP Laboratory”, that is expected to be published in 2018.