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Regulatory Affairs Project Management
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Complaint Handling
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Comparability Protocols for approved drugs
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Opportunities to speed your drug development and gain advantage
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Online News

Pharmascience Inc. - Career Opportunities
Vita Health Products - Career Opportunities
Pillar5 Pharma Inc. - Career Opportunities
Estée Lauder Companies- Career Opportunities
Temperature/Humidity Stability Test Chambers - Helping our customers make safe & reliable products
Validation Package Model – Human Control
Developing a Good Platform Requirements Specification (PRS)
Developing a Good User Requirements Specification (URS)
Successful Computer Compliance
Corporate Role for e-Record Quality
SOLABS QM 10.0: The First truly integrated eQMS software ever! Watch the Movie for a sneak peak!
Due Diligence Auditing of IT Services
WHAT IS THE MEANING OF “ADULTERATED”?
Validation and Outsourced IT Services
BAXTER HEALTHCARE CORP RECEIVES SINGLE WARNING LETTER FOR TWO LOCATIONS (05/31/13)
What is a Platform Requirements Specification (PRS)?
Why Write a Test Summary Report
What Is the Hardest Part of a Test Plan?
Why Can’t IT Write a Good System URS By Itself?
CAPCO Customer packaging Inc Receives warning Letter
Hameln Pharmaceuticals, Hameln, Germany receives warning Letter
Why Document System Testing?
Why Validate a Computerized System? If system manuals and training materials do not reflect the installed version of the system, work process mistakes could happen with its use.
TCP Reliable Announces the Hire of their Sales and Marketing Director for the European Market
Company Fails to Reply to Form FDA 483 From July 2012 Audit
Novatek Successfully Passes Third Party Independent on Site Regulatory Audit

Comments from participants

Pharmaceutical Microbiology
Montreal - Canada

Great couple of days - learnt alot & enjoyed the seminar. Very highly recoginized speakers - fantastic! Broad range of presentations - all understandable; interesting.
Product Manager – Thermo Fisher Scientific

Thank you again for offering this course. I am hoping I will have another opportunity to attend future courses.
Head of Bacterioogy unit - Sanofi Pasteur

Generation, Execution and Summary of IQ/OQ and PQ Protocols
Toronto - Canada

Ken was able to bring his wealth of industry knowledge, current guidelines, and best practices into the seminar. I can now bring back useful information into my role and its perfect timing for a new product launch I'm involved with.
Field Applications- TSI Inc.

knowledgable presenter/ enjoyed training
Senior Associate, QA - Abbott

GMP Update 2011
Montreal - Canada

Really enjoyed the public speakers as well as the program is a fantastic wealth of knowlege
Manufacturing Control Mgr – Afexa

I appreciate all conferences during these two days. Thank you
Documentation Auditor- Duchesnay

Excellent Seminar!
Director Reg. Affairs - Nutrasource

GMP Update 2012
Montreal - Canada

Overall its excellent
Regulatory Affairs Associate - International Pharmaceutical Generics Ltd

First time attending this conference. Very good topics + list of speakers. I will look at next years conference as a possbile one for me to attend
Sr. Quality Specialist - Rhodes Pharma