alexa Quality Risk Management System
ISSN: 2167-7689

Pharmaceutical Regulatory Affairs: Open Access
Open Access

OMICS International organises 3000+ Global Conferenceseries Events every year across USA, Europe & Asia with support from 1000 more scientific Societies and Publishes 700+ Open Access Journals which contains over 50000 eminent personalities, reputed scientists as editorial board members.

Open Access Journals gaining more Readers and Citations

700 Journals and 15,000,000 Readers Each Journal is getting 25,000+ Readers

This Readership is 10 times more when compared to other Subscription Journals (Source: Google Analytics)

Share This Page

Additional Info

Loading
Loading Please wait..
 

3rd International Conference on Pharmaceutical Regulatory Affairs
October 21-23, 2013 DoubleTree by Hilton Hotel San Francisco Airport, CA, USA

Shruti U. Bhat
Accepted Abstracts: Pharmaceut Reg Affairs
DOI: 10.4172/2167-7689.S1.012
Abstract
How often does this happen with you? Your product is developed and ready for scale-up... and there is a last minute change of manufacturing site! Reasons provided could be one or many of the following- ?Our Operations is way too loaded? or ?We are running back orders, hence can?t take up more? or ?Getting this manufactured at a contract location works better for our bottom line.? These reasons are absolutely valid for business, but they create havoc among product developers i.e. R&D personnel. The situation aggravates further when R&D finds out that, their process was developed using an ?Octagonal? blender, while the manufacturing site has only a ?V? blender. Further, there is no time to procure and qualify a new blender... and there is no way that ?Filing date? can be moved ... WoW...!! Such situations are when QRMS (Quality Risk Management Systems) are the only scientific saviours! This paper captures use of QRMS to situations such as above and similar, practical and commonly occurring scenarios within the pharmaceutical industry. Theoretically, QRMS can be applied to both (a) regulators and (b) manufacturers. This paper, however, shall cover aspects of QRMS as applied to the latter. As QRMS is an overall and continuous process of minimizing risk to product quality throughout its life cycle, QRMS is therefore, applicable both proactively and retrospectively. This paper shall cover- both proactive and retrospective aspects of QRMS, Verification of a QRM plan, Risk Management tools and Real- life case studies. Following case studies are being discussed at length- (a) Proactive QRMS: I. Quality-by-design (QbD) during drug- product development. II. QbD during stability studies. III. Risk Analysis prior to a process scale-up. (b) Retrospective QRMS: Internal audits, CAPA etc.
Biography
Shruti U. Bhat has completed Ph.D. in Pharmaceutics & Industrial Pharmacy, from University of Mumbai, India and a MBA from ITM- Southern New Hampshire University USA. She has over 17 years of work experience with Strategy Design & Implementation of QRM and other Business Process Improvement tools within the Pharmaceuticals and Life science industries at large. Shruti has published over 50 scientific papers and reviews in reputed journals and has over 30 patents to her credit. She is Chief Operations Officer at Innoworks Inc. a Canadian Management Consulting firm.
image PDF   |   image HTML
 

Relevant Topics

Peer Reviewed Journals
 
Make the best use of Scientific Research and information from our 700 + peer reviewed, Open Access Journals
International Conferences 2017-18
 
Meet Inspiring Speakers and Experts at our 3000+ Global Annual Meetings

Contact Us

Agri, Food, Aqua and Veterinary Science Journals

Dr. Krish

[email protected]

1-702-714-7001 Extn: 9040

Clinical and Biochemistry Journals

Datta A

[email protected]

1-702-714-7001Extn: 9037

Business & Management Journals

Ronald

[email protected]

1-702-714-7001Extn: 9042

Chemical Engineering and Chemistry Journals

Gabriel Shaw

[email protected]

1-702-714-7001 Extn: 9040

Earth & Environmental Sciences

Katie Wilson

[email protected]

1-702-714-7001Extn: 9042

Engineering Journals

James Franklin

[email protected]

1-702-714-7001Extn: 9042

General Science and Health care Journals

Andrea Jason

[email protected]

1-702-714-7001Extn: 9043

Genetics and Molecular Biology Journals

Anna Melissa

[email protected]

1-702-714-7001 Extn: 9006

Immunology & Microbiology Journals

David Gorantl

[email protected]

1-702-714-7001Extn: 9014

Informatics Journals

Stephanie Skinner

[email protected]

1-702-714-7001Extn: 9039

Material Sciences Journals

Rachle Green

[email protected]

1-702-714-7001Extn: 9039

Mathematics and Physics Journals

Jim Willison

[email protected]

1-702-714-7001 Extn: 9042

Medical Journals

Nimmi Anna

[email protected]

1-702-714-7001 Extn: 9038

Neuroscience & Psychology Journals

Nathan T

[email protected]

1-702-714-7001Extn: 9041

Pharmaceutical Sciences Journals

John Behannon

[email protected]

1-702-714-7001Extn: 9007

Social & Political Science Journals

Steve Harry

[email protected]

1-702-714-7001 Extn: 9042

 
© 2008-2017 OMICS International - Open Access Publisher. Best viewed in Mozilla Firefox | Google Chrome | Above IE 7.0 version
adwords