Short Course Listings
Short Course

Course Information
Course Title: (CANCELED) Good Documentation Practices and Effective Analytical Documents in Pharmaceutical GMP Laboratories
Categories: 1 - Liquid Chromatography
2 - Management/Professional Development
3 - Pharmaceutical Sciences
4 - Quality/Regulatory/Compliance
5 - Technical Writing
6 - Validation
Instructor(s): Kim Huynh-Ba Course Number: 43
Affiliation: PHARMALYTIK
Course Date: 03/07/2017 - Tuesday Course Length: 1 Day Course
Start Time: 08:30 AM End Time: 05:00 PM
Fee: $575 ($775 after 2/18/17) Textbook Fee:

Course Description
Current Good Manufacturing Practices (cGMPs) continue to be the standard practices in the pharmaceutical industry. This course will cover the key factors of writing effective GMP documents. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. It will then discuss critical structure of a protocol and then content that is necessary for a GMP report. Best practices for creating, implementing and maintaining a change control management system for all GMP documentations and getting these documents ready for inspection will also be discussed.

Target Audience
This course will benefit analytical chemists or investigators in QA/QC, R&D, project management, manufacturing, CROs, technical liaison, QA scientists, Regulatory scientists, Laboratory auditors, who are involved in working with generating, reviewing, evaluating analytical results of pharmaceutical products.

Course Outline
1. Good Documentation Practices
a. Lab documentation
b. Reporting data and rounding policies
c. Structure of an SOP
d. Different types of SOPs
e. Handling deviations and compliance investigations
2. Establish a GMP Protocol
a. Structure of a protocol
b. Development information
c. Determine scope/purpose
d. Setting acceptance criteria
e. Handling failures and exceptions
3. Put data together and write a GMP report
a. Presenting data to be presented in a report
b. Evaluation of data
c. Writing an executive summary
d. Conclusion
e. References
4. Lifecycle GMP Document
a. Original Document, Controlled and uncontrolled copy
b. Change Control Process
c. Record Retention Schedule
d. Approval of lifecycle GMP documents
e. Issuance, Distribution and Control of Lifecycle GMP documents

Course Instructor's Biography
Kim Huynh-Ba is the Executive Director of Pharmalytik (, 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 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, and many other international training groups