When Conducting cGMP Regulatory Inspections 2018
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Webinar by
Compliance4All
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On-Site
/ Webinar
USD 150.00
Details
Overview:
This webinar will cover the key areas of how ICH Q7 was
established, it's goals and objectives, expectations of the
healthcare authorities involved and practical differences that you
will experience in a GMP inspection of a facility by FDA, an EU
Competent Authority or PMDA.
Why should you Attend:
It has often been stated that "FDA inspects for compliance;
European inspectors inspect for adequate science". Yet GMPs have
been enshrined into law for many countries and a
drug/biologic/medical device manufacturer should have a
reasonable expectation of all inspections being the same. ICH Q7
was established by US / EU and Japan to harmonize inspections in
their respective countries.
Areas Covered in the Session:
Where Inconsistencies Become a Problem: WHO, ICH, Countries
Discrepancies in global expectations
Alignment issues
Key Chapter Reviews
ICH GMP organization
Category reviews
Who Will Benefit:
Manufacturing
Quality Control
Quality Assurance
Senior Management
Project Managers
Speaker Profile:
Angela Bazigos is the CEO of Touchstone Technologies Inc. She
has degrees in Microbiology and Computing and 40 years of
experience in the Life Sciences, Healthcare & Public Health
Services. Experience combines Quality Assurance, Regulatory
Compliance, Business Administration, Information Technology,
Project Management, Clinical Lab Science, Microbiology, Food
Safety & Turnarounds.
Event Fee: One Dial-in One Attendee Price: US $150.00
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]
http://www.compliance4all.com/control/w_product/~product_id=502024LIVE?channel=speedycourse_Aug_2018_SEO
This webinar will cover the key areas of how ICH Q7 was
established, it's goals and objectives, expectations of the
healthcare authorities involved and practical differences that you
will experience in a GMP inspection of a facility by FDA, an EU
Competent Authority or PMDA.
Why should you Attend:
It has often been stated that "FDA inspects for compliance;
European inspectors inspect for adequate science". Yet GMPs have
been enshrined into law for many countries and a
drug/biologic/medical device manufacturer should have a
reasonable expectation of all inspections being the same. ICH Q7
was established by US / EU and Japan to harmonize inspections in
their respective countries.
Areas Covered in the Session:
Where Inconsistencies Become a Problem: WHO, ICH, Countries
Discrepancies in global expectations
Alignment issues
Key Chapter Reviews
ICH GMP organization
Category reviews
Who Will Benefit:
Manufacturing
Quality Control
Quality Assurance
Senior Management
Project Managers
Speaker Profile:
Angela Bazigos is the CEO of Touchstone Technologies Inc. She
has degrees in Microbiology and Computing and 40 years of
experience in the Life Sciences, Healthcare & Public Health
Services. Experience combines Quality Assurance, Regulatory
Compliance, Business Administration, Information Technology,
Project Management, Clinical Lab Science, Microbiology, Food
Safety & Turnarounds.
Event Fee: One Dial-in One Attendee Price: US $150.00
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]
http://www.compliance4all.com/control/w_product/~product_id=502024LIVE?channel=speedycourse_Aug_2018_SEO
Outline
Special Offer
One Dial-in One Attendee
Price: $150.00
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Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. .
Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.
Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.