Day 1 of the 2021 ISPE Asia Pacific Pharmaceutical Manufacturing Conference kicked off this morning with keynote Dr. Ranjana Pathak, DHA, President-Global Quality, Medical Affairs & Pharmacovigilance, Cipla, giving the presentation “Quality Risk Management: Beyond Existing Tools and Models.”
Watch this clip to hear Dr. Pathak give her insight on must-haves for risk assessments.
Regulatory and Industry Panel: Maintaining Full transparency with Regulatory Agencies
The 2021 ISPE Asia Pacific Pharmaceutical Manufacturing Conference featured an exciting Regulatory and Industry Panel discussing maintaining full transparency with regulatory agencies.
In this clip, Davide Buratti, GxP Compliance Operations Director - Partner, PQE Group; R Derek Glover, Head of Global Quality, Viatris; Frances Marie Zipp, President & CEO, Lachman Consultant Services, Program Committee Co-Chair; and Dr. Ranjana Pathak, DHA, President-Global Quality, Medical Affairs & Pharmacovigilance, Cipla; share their insights on best practices from the industry concerning the management of CMOs and CDMOs.
Creating Comprehensive Responses to Regulatory Actions
With an increasing number of non-conformances, warning letters/OAIs for sites governed by US regulations, one has to ask what the missing link might be. Companies responding to regulatory actions need to create comprehensive responses that not only address their remediation plan but also identify how they intend to ensure the sustainability of the remediated processes.
During the 2021 ISPE Asia Pacific Pharmaceutical Manufacturing Conference, Narendira Kumar, Associate Director and Site Quality Head, Dr. Reddy's Laboratories, Scott Kaplan, Partner, Hogan Lovells, and program committee member Deva H. P., Head of Global Quality Investigations, Viatris, shared their insights on creating comprehensive responses to regulatory actions.
While Pharmaceutical development and manufacturing have focused for years on robust quality management systems (QMS), the application of quality risk management (QRM) applying digital tools and advances are critical to future success. Coupling controls, artificial intelligence, and associated platforms with basic QMS and QRM affords a great opportunity for the pharmaceutical industry.
Quality is the strongest force multiplier for any organization’s growth. Attaining higher quality levels has a multi-dimensional effect throughout any organization. Creating and sustaining a passion for quality brings higher levels of responsiveness, confidence and flexibility to organization wide manufacturing operations. Overall quality and manufacturing data as represented by effective...