PharmaAQ Expert Forum – OOS/OOT Investigations – Overcoming Challenges
Overview
PAQ (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 companies at a single platform to discuss the hottest issues and topics for achieving research and business objectives. The objective of this PAQ Expert Forum is to discuss the bottlenecks and their solutions for conducting successful OOS/OOT investigations.
Out-of-Specification (OOS) and Out-of-Trend (OOT) results are the laboratory incidents or deviations resulting in unexpected results. Such deviations need to be clearly identified, explained and documented before the same is pointed out by a regulatory assessor. In pharmaceutical organizations OOS/OOT investigations are performed following standard protocols and checklists with the objective of finding the root cause of the deviation. Detailed investigations are done on the materials, chemicals, instruments procedures and personnel/analysts involved in the analysis to conclude the reason for OOS/OOT results.
Incorrectly documenting, improper investigation, incorrectly explained root cause, faulty management of OOS/OOT results and improper CAPA (Corrective and Preventive Actions) have resulted in warning letters as well as serious implications in Pharma and CRO companies in past as well as recently. This PAQ Expert forum will deliberate on the topic of OOS/OOT Investigations, its challenges, solutions, case studies and best practices with respect to their identification, investigation, management as well as ways to minimize them. This discussion forum will be held on October 22, 2021, virtually. This 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.
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
22-10-2021
Conference Agenda
- Identifying OOS & OOT Test Results and CQA Risk Assessment
- OOS Investigations-Critical Factors in Designing and Conducting
- Minimizing OOS/OOT Results in an Analytical Laboratory
- Handling OOS Reports and Regulatory Queries
