CPhI 2nd Annual cGMP Workshop

CPhI’s 2nd Annual cGMP Workshop

Recently several pharmaceutical companies have been issued for non- compliance to the regulatory guidelines.

There is a need in the industry to gain knowledge about the regulatory guidelines and their interpretation as well as the current and trending issues in the industry.

Taking this into consideration, UBM is glad to bring you CPhI’s 2nd Annual cGMP Workshop. The workshop will focus on critical topics in the industry keeping in mind the updates in the regulatory guidelines.

TRAINER

Gary Bird

Principal at PharmaConsult Global, ltd

Throughout his career, Gary has held leadership positions at pharmaceutical and biotech-related organizations including the Food and Drug Administration (CDER and CBER), Eli Lilly and Company and GTx Incorporated.

Achievements:
  • Gary has represented both FDA and Industry in the International Conference on Harmonization (ICH) negotiations.
  • Gary has been responsible for developing and overseeing a Corporate Quality System for all GXP compliance activities while ensuring continuous improvement in system reliability by creating and implementing a Corporate Quality Plan
  • Gary has overseen all non-clinical (GLP), manufacturing (GMP), and clinical trial (GCP) activities and ensuring their compliance with relevant laws and regulations, including creating a GCP audit program to monitor clinical trials conducted inside and outside of the US.
He has authored and delivered numerous lectures and training courses on subjects including best manufacturing practices for biopharmaceutical products, introduction to GMPs, introduction to biosafety, and stability of biopharmaceutical products.

Atul Shirgaonkar

CEO Insight Systems Inc.

Thirty two years in the Pharma Industry in various discipline and capacities including consulting practice.

Training : Conducted more than ONE THOUSAND NINE HUNDRED SEVENTY FIVE ( 1975+ ) Training Programmes ( 50, 000 plus participants ) within India and overseas ( participants of nineteen countries ) in GMP as well as Functional, Technical and Behavioural aspects of Management. Addressed symposia on GMP, Quality and Management in various National and International forums.

Audits : Conducted more than 100 GMP audits for API and Excipient manufacturers, Finished Dosage Form ( FDF ) manufacturers, Cosmetic manufacturers, Food and Medical Device manufacturers, R&D setups and test laboratories.

Books and Publications : Achieving Quality and Compliance Excellence in Pharmaceuticals – published by business horizons ( Co-authored ) Employees First Customers Next – Published by Himalaya Publishing House ( Co-authored ) Authored several GMP monographs and articles in leading magazines and dailies on Quality, GMP and Management.

TOP REASONS TO ATTEND

  • To gain better understanding of how the regulatory authorities look at pharma operations and to anticipate problem areas before they create problems during the inspection
  • Learn from the experienced FDA expert who has been a part of various inspections and issued warning letters on cGMP
  • To understand the current cGMP inspection trends in the Indian pharma companies
  • To obtain current information about FDA activities
  • To get your burning challenges and questions answered by the expert through an exclusive Q&A session

WHO SHOULD ATTEND?

Vice President, General Managers, Senior Managers, Managers, Executive
from:

Manufacturing Quality Assurance Production Quality control Engineering Tech transfer
Belonging to Pharma Manufacturing Companies

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KEY HIGHLIGHTS OF THE WORKSHOP

  • International speaker
  • Speaker to give India perspective
  • Practical case studies

WORKSHOP ON

  • Chapter 1 - Pharmaceutical Quality System
  • Chapter 2 - Personnel
  • Chapter 3 - Premise and Equipment
  • Chapter 4 - Documentation
  • Chapter 5 - Production
  • Chapter 6 - Quality Control
  • Chapter 7 - Outsourced activities
  • Chapter 8 - Complaints and Product Recall
  • Chapter 9 - Self Inspection

EVENT PARTNERS

Exhibit Partners

Branding Partner

MEDIA PARTNERS