Overview of GLP in pharmaceutical analytical laboratories
Dr. Ganesh Prasad Overview
The lecture will provide an understanding of various elements of GLP as applied to chemical analysis in a typical pharmaceutical QC / AR&D laboratory. The discussion will focus on various laboratory controls and disciplines to be followed in order to ensure accuracy and reliability of test results. The session will also cover how to handle Out of Specification (OOS) results and document the same. Regulatory expectations on control of electronic data in QC laboratory to assure integrity of laboratory data will also be discussed.
Why you should Attend
To understand the regulatory expectations on the level of controls to be used in analytical chemical laboratories to ensure that the reported lab results are consistently accurate and are documented to provide complete traceability.
Areas Covered in the Session
- General lab controls
- Calibration program
- Instrument qualification
- Control of lab reagents
- Control of standards
- OOS investigation
- Data integrity
Who Will Benefit
- QC Analysts
- QA chemists and R&D and analytical R&D chemists
Speaker Profile
Dr. Ganesh Prasad is a freelance Pharma consultant in India under the banner ‘Q_Pharma consulting India & holds a doctorate degree in Organic Chemistry from Indian Institute of Science, Bengaluru. Previously, he worked at senior levels in pharmaceutical companies like Apotex Pharmachem India Pvt Ltd, ICI Pharmaceuticals, India and other organisations heading QA/QC/Process functions. He has also worked as scientist in the US FDA laboratory in Washington and other reputed institutions in USA/ Canada/India. He has together more than 30 years of experience together in quality assurance function, research in academia and industry. As a consultant he has assisted many pharmaceutical companies towards establishing cGMP standards of US FDA, European and Indian regulatory agencies. He also conducts third party quality audits of pharmaceutical manufacturers. He has conducted many public and in-house workshops and delivered invited lectures in forums like UBM, ISPE, DIA and so on.