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CPhI PAT & QbD Workshop

The Complex Generic Course will address the critical development stages and determination of QTPP for such a product as well as defining the mission statement effectively initially. It will identify key decision for comparators and for selection of batches for BE studies. It will ensure developers now what companies are looking for and allow effective due diligence. The course will teach you how to bring a generic drug / complex generic drug to market whilst assuring you meet the regulatory challenges and compliance issues. This course will allow the participants to gain a strategic insight into key requirements for developing generics from a global perspective and an overview of the generics market; current trends and practices; and future strategies for regulatory compliance. There will be time on this course to discuss the likely implications of CMC decision and BE decision / outcomes on the strategies for Generics

Regarding CMC Sections of the CTD is a very practical presentation set incorporating key element of PAT and QbD with respect to needs for global dossier, use of FMEA and effective linkage of CQAs and CPP to material attributes using techniques in QbD triangle practical which is used by multiple companies both small and large. The definitions and level of data expected is addressed with anecdotes provided. Furthermore the Quality and Pharmaceutical Module (Module 3) of the CTD is challenging and requires considerable expertise to manage it. This course will provide you with a clear understanding of the US and European regulatory requirements for Module 3, PAT and QbD, and will show you how to compile this important part of your submission dossier. The Indian pharmaceutical industry has been undergoing a significant transformation to streamline their Research and Development (R&D) process, provide greater manufacturing flexibility and control, and to reduce regulatory burden.

Key Topics 2020
Current industrial and regulatory perspectives on QbD and PAT in pharmaceuticals and (bio)pharmaceutical development
Innovations in continuous manufacturing science and technology for biologicals and pharmaceuticals
Upstream and Downstream QbD - PAT Applications
Case studies of successful implementation of PAT from development to manufacturing
Workshop Trainer
Andrew Gareth Willis
Independent Consultant in Advanced Regulatory Affairs and Pharmaceutical Development

Mr. Andrew Willis is an independent consultant with 34 years of experience in regulatory affairs and pharmaceutical development. Mr. Willis has been involved in successful registration of Centralized approval for NCE and CMC lead for vaccine projects. Provides training for all major companies and also a number of EU Member states agencies in CMC, Quality By Design, Global Module 3 Requirements, Global Generic development and Optimization of the Life of the product. Mr. Willis has completed his bachelor’s in Organic Chemistry from University of South Wales.

2019 SPEAKERS
Mansoor Khan
Texas A&M University, Rangel College of Pharmacy
Professor and Vice Dean, Presidential Impact Fellow
Dr. Gautam Samanta
Cipla
Vice President
Krishna K. Venkatesh
Dr. Reddy’s Laboratories
Senior Vice President & Head, MSAT
Venkateswarlu Vobalaboina
Neuheit Pharma Technologies Ltd
Managing Director
Aruna Khanolkar
Cipla
Director
Dr. Srividya Ramakrishnan
Dr. Reddy’s Laboratories Ltd
Head - Process Engineering (Drug Substance)
Arani Chatterjee
Aurobindo Pharma
Senior Vice President, Clinical Research
Jaya Abraham
Pharma
Consultant
Benefits of Attending
Understanding the guidelines from regulators
International Trainer
3-day extensive learning
Case studies from top companies
WHO SHOULD ATTEND
Designations
  • Vice Presidents
  • Associate Vice Presidents
  • Directors
  • Associate Directors
  • Deputy General Manager
  • General Manager
  • Senior Managers
  • Managers
  • Assistant Managers
  • Senior Executives
  • Principal Engineer
Industries / Categories:
Pharmaceuticals Life sciences Bio-Pharmaceuticals
Departments
Process Engineers QA Product Development/ Research and Development
WHO SHOULD PARTNER
Companies offering QbD and PAT Solutions
  • PAT Tools Providers
  • QbD consultants
  • Software solutions
Industries / Categories
  • Pharma Technology and Software Providers
EVENT PARTNERS
Gold Partner
Silver Partner
Associate Partner
Exhibit Partner
Media Partners