PharmaAQ Expert Forum – Analytical Method – Qualification, Validation & Transfer
Overview
PharmaAQ (Pharma Analysis and Quality) Expert Forum is a technical discussion group comprising of Senior Team Leaders and/or R & D Heads. The forum envisages bringing together both the Pharma and CRO companies at a single platform to discuss the hottest issues and topics for achieving research and business objectives.
The US Food and Drug Administration (US FDA) guidance on process validation describes three stages viz. process design, process performance qualification, and process performance verification. For an analytical method, a method procedure must be monitored efficiently. Before an analytical method can be validated, it is required to define the method development goals and its acceptance criteria usually referred to as analytical target profile. The analytical method development for quality control follows GMP and QbD principles and must be validated for its specificity, accuracy, precision, linearity, range LOD and LOQ etc. Analytical methods are developed using strict validation protocols. The USP states that the transfer of an analytical method is the documented process that qualifies a laboratory (receiving laboratory) to use an analytical method that originated in another laboratory (transferring laboratory), whether that is internal or external to the receiving laboratory.
This discussion forum will be held on November 18, 2021, virtually and is brought to you by the organizing team of Pharma Analysis and Quality conferences in Mumbai on 11-12 October 2018 and Round-table meetings on Nitrosamine Impurities in December 2019 and February 2020. This forum will deliberate upon the various practical aspects of the analytical method pre-validation or qualification, validation, verification and transfer, challenges in developing a robust method, regulatory compliance for analytical methods as well as other issues related to analytical method development and validation.
The H2L Concept- The H2L or Honing to Lead is a novel concept and means honing or refining skills of the team leaders who have the responsibility to steer their team towards achieving the organizational goals. The H2L concept is about refining specifically the technical skills of the team leaders through higher level experts who have vast first-hand experience in the respective areas so that the leader gets an extremely focused conceptual insight into the problem area. This essentially involves bringing together the leaders who share a common platform with the Experts and where the Experts develop an atmosphere conducive to open discussion rather than a regular speaking-listening session.
Who Should Attend
Heads, Vice Presidents, Directors, Senior Managers, Team Leaders, Senior Scientists from Pharma and CRO Organizations working in various domains: Analytical Method Development, Quality control, Formulation Development, Regulatory Affairs, Quality Assurance, Data management/data integrity, and Pharma R&D.
Contacts
Technical Query: Ms. Pooja Sharma, M: 7696325050, Email: p.sharma@glostem.com
Participation Query: Ms. Swati Kanwar, M: 8289015050, Email: s.kanwar@glostem.com
Registration Support: Ms. Ankita Kanwar, M: 7696425050, Email: ankita@glostem.com
Conference Date
18-11-2021
Conference Agenda
- Analytical Method Development-Critical Review
- Analytical Method Qualification and Validation
- Method Validation Protocols
- Analytical Method Transfer-Best Practices
