The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: December 8, 2021 at 9am to December 9, 2021 at 4pm
Street: Compliance Online
City/Town: Palo Alto
Website or Map: https://www.complianceonline.…
Event Type: webinar
Organized By: ComplianceOnline
Latest Activity: Nov 1, 2021
Reliable analytical results are necessary to make informed decision about the quality and safety of the products in the pharmaceutical industry. In addition, such analytical data are required for regulatory submissions in support of the drug product registrations. Therefore, meaningful experimental designs including system suitability parameters must be planned for the intended use of the procedure.
In this course, general guideline for the determination of the analytical characteristics for different types of validation procedures is highlighted for the analysis of both the drug substance and drug product. The factors to consider for verification of the compendial procedures will also be discussed. In addition, different approaches for the transfer of analytical procedure from one lab (transferring) to other lab(s) (receiving) under different circumstances will be covered. Other related topics for obtaining reliable data will also be discussed. These topics include analytical instrument qualification as well as how to set, handle and monitor specifications.
Due to global nature of pharmaceutical industry, other quality topics on both regulatory (ICH) and compendial (USP) harmonization are also covered. These topics are valuable for scientists directly or indirectly involved with the drug development, analysis. stability studies or regulatory/compendial submissions.
Pharmaceutical Industry, Contract Laboratories (CRO), government (FDA or regulatory authorities), Academia (pharmacy, Pharmaceutical, Chemistry)