alexa FDA Process Validation Guidance & Principals Vs EMA Guidance
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

Rober Remon Saad Habashy
ScientificTracks Abstracts: Pharmaceut Reg Affairs
DOI: 10.4172/2167-7689.S1.010
Abstract
The discussion will clarify the differences and updates between process validation definition & content in the FDA guidance document for process validation 1987 and the new guidance issued in 2011. Introduction of new terminologies to process validation instead of validating the current process to process design as stage 1, then process qualification and utilizing statistical tools for evaluation as Stage 2. Then continues process verification of the validated process covered by stage 1 & 2 using trend analysis, OOS & statistical/ SPC tools for control as Stage 3. Alignments of the validation guidance of 2011 with the ICH Q8 for pharmaceutical development /QbD terminologies and definitions like target product profile (TPP), target product quality profile (TPQP) critical quality attributes (CQAs) critical process parameters (CPP) etc. The new guideline includes modern technology scientific approach, innovation and continuous improvements through product and process understanding and uncovers new areas of Improvements. EMA guidance update and draft issuanceto cope with FDA guidance document for process validation, current differences between EMA & FDA guidance will be addressed and the content of each guidance will be discussed in brief.
Biography
Rober Remon Saad Habashy has completed his Bachelor degree in Pharmaceutical Science, 2007 at the age of 22 from Misr International University School of Pharmacy. He completed his Total Quality Management (TQM) Diploma from the American University in Cairo, 2009. He became certified Six Sigma Black Belt (CSSBB) from the American Society for Quality (ASQ) October 2011 as well as did Diploma in Quality Assurance in the same year from the American supplier institute (ASI). He is the Training Chair at the American Society for Quality Local Member Community (LMC) in Egypt. He is a core member, senior research & development pharmacist at Amoun Pharmaceutical Company, Cairo, Egypt. He works at the R&D department and responsible for analytical test method development and validation as well as formulation and pre-formulation studies, product/ process design for human/vet pharmaceutical products.
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 & Aquaculture Journals

Dr. Krish

[email protected]

1-702-714-7001Extn: 9040

Biochemistry Journals

Datta A

[email protected]

1-702-714-7001Extn: 9037

Business & Management Journals

Ronald

[email protected]

1-702-714-7001Extn: 9042

Chemistry Journals

Gabriel Shaw

[email protected]

1-702-714-7001Extn: 9040

Clinical Journals

Datta A

[email protected]

1-702-714-7001Extn: 9037

Engineering Journals

James Franklin

e[email protected]

1-702-714-7001Extn: 9042

Food & Nutrition Journals

Katie Wilson

[email protected]

1-702-714-7001Extn: 9042

General Science

Andrea Jason

[email protected]

1-702-714-7001Extn: 9043

Genetics & Molecular Biology Journals

Anna Melissa

[email protected]

1-702-714-7001Extn: 9006

Immunology & Microbiology Journals

David Gorantl

[email protected]

1-702-714-7001Extn: 9014

Materials Science Journals

Rachle Green

[email protected]

1-702-714-7001Extn: 9039

Nursing & Health Care Journals

Stephanie Skinner

[email protected]

1-702-714-7001Extn: 9039

Medical Journals

Nimmi Anna

[email protected]

1-702-714-7001Extn: 9038

Neuroscience & Psychology Journals

Nathan T

[email protected]

1-702-714-7001Extn: 9041

Pharmaceutical Sciences Journals

Ann Jose

[email protected]

1-702-714-7001Extn: 9007

Social & Political Science Journals

Steve Harry

[email protected]

1-702-714-7001Extn: 9042

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