Evolving Quality Culture in Indian Pharmaceutical Industry

Taking Pharma Regulatory Compliance to the Next Level: Managing FDA Audits, Inspections, and CAPA with Training

Timeline: 24th March 2015

ITC Maratha, Mumbai, India

PROGRAM AGENDA

Time / AGENDA / Speaker
9:00 am – 9:30 am / Registration & Coffee/Tea
9:30 am – 9:40 am / Welcome Address / Ms. Kavita Mehrotra – Global Strategic Alliance Head, UL EduNeering
9:40 am – 9:50 am / Introduction / Shri. S M Mudda – Chairman Regulatory Affairs Committee, IDMA Mumbai
9:50- 10:00am / Special address / Shri. S V Veerramani – President , IDMA
10:00 am- 10:10 am / Inaugural speech / Mr. Suresh Sugavanam MD UL India
10:10 am – 10:30 am / Keynote address / Shri. Sudhansh Pant – Jt. Secretary, Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers, Government of India
10:30 am- 11:00 am / Need for building a Quality & Compliance Culture / Mr. Solomon Yimam – Asst. Director, US FDA, India Office
11:00 am – 11:20 am / Tea Break
11:20 am – 11:50 am / QbD and Quality Culture / Dr Ajaz Hussain, Executive Director , NIPTE( National Institute of Pharmaceutical Technology & Education ) USA & Founder CEO , Insight Advice & Solutions LLC.
11:50 – 12:30 pm / Human Performance Management : How Competency development helps in building efficiency / Scott Barnard – VP LifeSciences, UL EduNeering
Industry Expert:
12:30 – 1:10 pm / How to Handle CAPA: An Insight into CAPA and Process Based Learning Modules / Dr. Sanjay Shetgar Vice President QA, Generics, Dr. Reddy’s Laboratories
1:10 pm – 2:00 pm / Lunch Break & Networking
Panel Discussion:
2:00 pm-3:00 pm / Building a Compliance Culture – How Learning & Development helps cut across culture / Panelists:
·  Mr. S M Mudda – Executive Director , Technical & Operations, Micro Labs
·  Dr. Ajaz Hussain - Executive Director , NIPTE( National Institute of Pharmaceutical Technology & Education ) USA & Founder CEO , Insight Advice & Solutions LLC
·  Mr. Anthony Raj Gomes – VP, QA, Mylan India
·  Dr. Ranjana Pathak – VP, QA, Cipla
·  Dr. H G Koshia-Commissioner, FDCA, Gujarat
·  Dr. Bangarurajan – Dy. Drug Controller, West Zone, CDSCO
Session Moderator:
·  Ms. Kavita Mehrotra
3:00 pm – 3:45 pm / Inspection Readiness: Hard skills,Etiquette, and Documentation
(How Training Curriculums can equip companies towards audit readiness) / Scott Barnard – VP Lifesciences, UL EduNeering
3:45 pm -4:00 pm – / Summing Up / Kavita Mehrotra
4:00 pm – 4:10 pm / Vote of Thanks / Mr. Daara Patel
4:10 pm -4:30 pm / Winding up with Tea/Coffee