Building Quality in Development and Manufacturing

For Pharmaceutical & Biopharmaceutical Industry

16 - 17 March - 2017

This Event is Successfully Ended

Conference & Training

Date
16 - 17 March - 2017

Time
09:00am - 7:30pm

About This Event

QbD & PAT conference will bring together participants from industry, academia and regulatory creating invaluable opportunity to discuss the recent developments, future trends, challenges and Solutions for development & Manufacturing of Pharmaceutical & Biotechnology products.

The conference will focus on discussing the existing challenges and explore practical applications related to drug development, manufacturing and regulatory. Its a 2 day program which will include presentations, talks, case studies, panel & Round-table discussions from industry leaders, solution providers and academia.

The Day 2 will be dedicated to training/workshop. Below are few benefits of attending our conference.

Align with the current regulations and ensure getting first time approval. Discuss the most updated Regulaory landscape and learn to deliver to expectation

Improved process and product knowledge and understanding

Fast and reliable to market

Learn the best practices for DOE throughout product life cycle

Improved control strategy

Improvement in product quality and product roustness/reproductibility

Establish Quality Risk management strategies

Bridge gap between Batch & Continuous processing

Gain competitive adavantage -look at the role of QbD& PAT in future of R& D and manufacturing

DAY 2 - TRAINING

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DR JEFF DUKE
Consultant
United Kingdom

TRAINING LEADER

The implementation of Quality by Design (QbD) provides Cost-efficient approach to assure safe, efficient & high quality drug supply to the consumers and promises to improve manufacturing quality performance.The regulatory authorities European Medicine Agency (EMA) and the U.S Food and Drug Administration (FDA) have also placed emphasis on QbD as a part of regulatory filling. The pharma companies applying Quality by Design (QbD) Principles for new and existing drugs are reporting considerable business benefits such as reduced operating cost, improved, more efficient manufacturing processes and better meet the regulatory expectations. This course in QbD is designed to help delegates understand the underlying philosophies behind QbD, regulatory expectations as well as giving hands on training in the most common tools and techniques utilised in QbD.
The objective of the course is to provide scientists with the tools and understanding needed to apply QbD confidently in their projects as well as helping mangers and senior managers understand the rationale for applying QbD and overcome potential issues that they commonly face.

Speakers for the event

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Gautam Samanta
Head-QbD,Scale-up and Tech Transfer
Cipla Ltd

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Dr. Amrendra Kumar Roy
QbD Head
Jubilant Generics

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V. SIVAKUMAR
Associate Director – Corporate Quality Assurance
Mylan Laboratories Limited

Our Partners

MEDIA PARTNER

Some of the topics to be covered

  • Assessing Regulatory Considerations -EU & US
  • Qbd & PAT for Small molecules
  • QbD & PAT for Biologic
  • Experimental Design
  • Cases studies - API/Generics
  • Implementing Quality Risk management
  • Process Knowledge & Process Monitoring Methods
  • Manufacturing
  • Implementing Continuous Manufacturing for Drug Product
  • Manufacturing Unit operations: Batch Processing;Continuous API and Solid Dosage manufacture
  • Upstream and Downstream QbD - PAT Applications

Some Memories of event

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Who should attend

  • Regualtory QA/QC and Compliance Process Analytics
  • PAT QbD Lead Engineering
  • Technical Senior Scientist
  • Product Specialist Process Development Chemistry Business Analyst
  • Manufacturing Manager R&D Manager
  • Director Biotechnology Director
  • Technical Director

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Download brochure now!

FOR PARTNERSHIP & EXHIBITION PACKAGES

Heaton Paul
Business Manager
Heaton.paul@biotrains.com
+91 988 680 4123

FOR MARKETING AND MEDIA PARTNERSHIP

Lisa Brown
Marketing Manager
lisa.brown@biotrains.com
+91 704 514 8647

FOR SPEAKERS CONTACT

Rachna Tiwari
Conference Manager
rachna.tiwari@biotrains.com
+91 8433632006

FOR DELEGATE REGISTRATION

Rahul Sharma
Business Development Manager
rahul.sharma@biotrains.com
+91 989 272 9885


Hyatt Regency Mumbai

Qbd & Pat is organised at this beautiful place

FOR DELEGATE REGISTRATION

Rahul Sharma

+91 989 272 9885 rahul.sharma@biotrains.com