GMP Requirements for Records and Reports – Documenting Your GMP Activities; Understanding the Vital GMP Requirements of a Documentation System
Live, Interactive Training Webinar
Available Live On-Demand
Instructor: Kim Huynh-Ba Biography>>>
Available Live On-Demand
In the GMP world, when things are not written down, they are not considered happening. Therefore, documentation system is extremely important to reconstruct and evaluate laboratory controls and to ensure product quality and safety. 21 CFR 211 Subpart J lists requirements on records and reports. Documentation provides both procedures and evidence of activities being complete according to the standard operation procedures.
This live training webiar will discuss the requirement of a documentation system; define raw data, records and reports. It will also include key information to maintain data integrity and traceability.
-GMP requirements for records and reports.
-Defining raw data, records and reports.
-Good Documentation principles.
-Data integrity and traceability.
-Establishing protocols and reports.
-Evaluating and storing analytical data.
Webinar outline and time breakdown:Time*
|10:15 AM||Log In Period|
|10:40 AM||GMP requirements for records and reports,|
|Defining raw data, records and reports,|
|Good Documentation principles,|
|11:40 AM||Data integrity and traceability,|
|Establishing protocols and reports,|
|Evaluating and storing analytical data,|
|12:30 PM||Live 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 participation for attendee training records
Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:
- Quality Assurance personnel
- Quality Control personnel
- Research & Development
- Regulatory Affairs Professionals
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 Astra Zeneca (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>>>
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