Writing Stability Reports for Regulatory Submissions & A Comprehensive Review of cGMP Requirements for Records and Reports
Live, Interactive Training Webinar
Date: Wednesday November 8, 2023
Time: 10:30 am - 12:30 pm ET (New York Time)
Instructor: Kim Huynh-Ba Biography>>>
Registration Form ►Stability profile is a critical quality attribute and stability data are used to establish the shelf life of pharmaceutical products. Therefore, stability report is an important component of any regulatory submission. These reports contain detailed information and must be accurately. Most observations or warning letters are resulted from inadequate documentation, whether a company is using paper or electronic system. This live training webinar will discuss cGMP requirements on records and reports, and also introduce key factors to enhance integrity and quality of Stability reports.
Learning Benefits:
- Understanding regulatory expectations for Stability Data and Reports.
- Defining documentation system for reporting data.
- Designing recording system of raw data to better review routine testing and effectively trend stability results.
- Structure of a Stability Report.
- How to prepare a Technical Stability Report.
- Presentation of analytical data.
- Writing a stability summary.
Webinar outline and time breakdown:
Time*
10:15 AM Log-In Period
10:30 AM Introduction
cGMP Requirements on data reporting,
Impact of record deficiency,
Warning Letter Citations,
Recording stability data for submission,
11:30 AM 10 Minute Break
Anatomy of a Stability Report,
Designing and formatting summary reports,
Determine deficiencies and assess risks of documentation,
Integrating laboratory records to accelerate the Data Reporting Process,
12:30 PMLive Questions & Discussion
*Please note all times are Eastern Time (New York Time)
This live training webinar includes the following for each registered attendee:
- A copy of the presentation slides
- A certificate of training for attendee training records
Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:
- Quality Control
- Quality Assurance
- Regulatory Affairs Professionals
- Manufacturers of raw material and ingredients
- Pharmaceutical Scientists
- Compliance Scientists
- Analysts and Laboratory Managers
How to Attend:
All Pharma Webinars live training programs audio and visuals are delivered via Cisco WebEx with a basic system requirement of a computer with internet access. You do not require a Webex account to join Pharma Webinars’ live training courses, participants receive an email invitation that provides the access you need to join the meeting.
Instructor: Kim Huynh-Ba
Kim has almost 25 years of experience in analytical development, project management, strategic drug development and stability sciences. Prior to Pharmalytik, she held technical positions in drug development at Astrazeneca (formerly ICI Americas), DuPont Merck, DuPont Pharmaceuticals, Bristol Myers Squibb and Wyeth Vaccines. Her experiences range from analytical development to supporting CMC activities of multiple regulatory submissions, addressing regulatory responses to observations or investigations, or developing stability submission strategies.
She is an Adjunct Professor at Temple University-School of Pharmacy, Illinois Institute of Technology and Widener University. Kim currently is a member of United States Pharmacopeia (USP) General Chapter Expert Committee (2010-2015) and USP’s Reference Standard Project Team (2009-2010). She is also a member of the CHPA’s Impurities Breakout Group. She is chair of AAPS APQ Distance Learning and organized several APQ Open Forums. She serves on the Executive Committee of Governing Board of Eastern Analytical Symposium (EAS). She is the editor of the “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices” published in 11/2008, and also “Pharmaceutical Stability Testing to Support Global Markets” published in 01/2010… Full Bio>>>