The theme for this year’s convention was, ‘Challenges in Global Quality Management’
The Indian Drug Manufacturers’ Association (IDMA) and the Association of Pharmaceutical Analysts’ recently organised the 17th Pharmaceutical Analysts’ Convention in Mumbai. The theme for this year’s convention was, ‘Challenges in Global Quality Management.’
The PAC 2014 commenced with the lighting of the lamp by the dignitaries. The inaugural session was facilitated by Daara B Patel, Secretary General, IDMA.
SV Veerramani, President, IDMA welcomed the delegates, guests, invitees and supporters. The chief guest Dr Ronald T Piervincenzi, Chief Executive Officer, United States Pharmacopoeial Commission and the Guest of Honour, Dr K Bangarurajan, Deputy Drugs Controller,(I) CDSCO (West Zone) were formally introduced to the congregation by Patel.
Around 200 participants from various disciplines such as pharma analysis, quality control, quality assurance, regulatory, production, R&D, academia, marketing, media etc., including guests and invitees attended the convention. Past presidents and executive committee members of IDMA along with IPC Officials, CDSCO Officials and members of the USP also participated. The event was supported by over 15 companies including LGC Promochem, Vacs Technologies, Shasun Pharmaceuticals, Micro Labs, Fourrts (India) Laboratories, Mercury Laboratories, Alembic Pharmaceuticals, Schott Kaisha, Manish Analytical Labs, Crescent Scientific Instruments, Sotax India, Thermofisher, Pharmaffiliates, Oasis I-Tech, Conval Group & the United States Pharmacopoeial Commission.
The PAC 2014 commenced with the ceremonious lighting of the lamp by the dignitaries. The inaugural session was facilitated by Patel. Patel said, “The Pharmaceutical Analysts’ Convention is a ‘movement’ conceived, organised and run by Pharmaceutical Analysts for Analysts with the active support of the IDMA Secretariat. PAC. It brings together personnel from all aspects of the industry on a common platform to discuss the achievements and future initiatives of the domestic and international pharma industry.”
Piervincenzi’s in his keynote address thanked India for providing the highest number of expert volunteers after the US which was appreciated by all the participants. Piervincenzi and other dignitaries released the 17th IDMA-APA-PAC 2014 Souvenir and the APA FORUM quarterly newsletter. The ‘Young Pharmaceutical Analyst Award 2014’ was awarded to Dr N Satheesh Kumar, NIPER.
The ‘Outstanding Pharmaceutical Analyst Award 2014’ was presented to AG Raghu, Gland Chemicals. Awards were also given to JL Sipahimalani, and G Asrani, for their contribution towards IDMA’s training initiatives in technical and quality management.
The technical session was facilitated by Dr Milind Joshi, President, Global Regulatory Management, JB Chemicals & Pharmaceuticals.
Dr Nandkumar Chodankar, Chief Executive Officer and Promoter Director on Board, ASolution Pharmaceuticals delivered a presentation on, ‘Challenges in Global Quality Management – API.’
SM Mudda, Executive Director, Technical & Operations, Micro Labs spoke on, ‘Challenges in Global Quality Management – Formulations’, Rajiv Joshi, Partner, Fraud Investigation Dispute Services, Ernst & Young delivered a presentation on, ‘Eagle’s Eye on Quality Systems,’ Dr Raman Mohan Singh, Principal Scientific Officer, Indian Pharmacopoeial Commission, Ministry of Health & Family Welfare spoke on, ‘Frequently asked Queries Related to the Indian Pharmacopoeia.’ Dr KV Surendranath, Senior Vice-President, United States Pharmacopoeial Commission delivered a speech on, ‘USP Perspective on Elemental Impurities based on general chapters (232) and (233).’
Milind Dhupkar, Business Consultant – IT, Analytics and SCM, VACS Technologies spoke on, ‘Technology for a Global Business.’ Sanjay Dasmohapatra, President – Technical and Operations, Medopharm delivered a presentation on, ‘Self Inspection and Quality Audit: An effective way to ensure compliance of practices with the laid down GMP standards.’
Dr Kavita Mehrotra, Global Head, Global Strategic Alliances, UL (Underwriters Lab EduNeering spoke on, ‘Before During and After a Regulatory Audit.’ AG Raghu, Technical Director, Gland Chemicals spoke on ‘Operational Excellence.’
R Raghunandanan, Pharmaceutical Consultant, Mumbai delivered a presentation on, ‘Criticality of Laboratory Documentation.’
Breakout sessions were held where delegates were divided into four groups, with a thought leader directing deliberations in each group. Each group elected a member to take down all the key points from the session and create a presentation, which was then delivered by a representative delegate on behalf of the group. This session was facilitated by Kapil Bhargava, Consultant and Director, ISPE USA – India Affiliate.
Breakout session 1 was on ‘Quality Culture (Management/ Involvement/ Attitude),’ where the thought leader Gidy Asrani, Vice Chairman of IDMA Quality Management & Technical Sub-Committee and Founder President, Pharmacon. The breakout session 2 on was ‘Investigations and Effective CAPA Systems’ and the thought leader was Vijay Kshirsagar, Consultant, Board of Directors, ISPE. Breakout Session 3 on ‘Documentation and Records Management’ and the thought leader was Shailesh Nagarsenkar, Pharmaceutical Consultant. The breakout session 4 was on ‘Recent Challenges in Global Regulatory Management’ where Meena Shah, Senior Manager, Regulatory Affairs, JB Chemicals & Pharmaceuticals was the thought leader.
EP News Bureau – Mumbai