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Réf : 27503
Evènement :When Conducting cGMP Regulatory Inspections 2018

Date :Jeudi 16 Août 2018

Lieu :En ligne (Internet, Visioconférence, ...)

Type :Formation - Audience Internationale

Accréditation :--


 

Informations

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: support@compliance4All.com
http://www.compliance4all.com/control/w_product/~product_id=502024LIVE?channel=doctorama_Aug_2018_SEO

Renseignements

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Annonceur

Compliance4All
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 [...]

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Précisions

When Conducting cGMP Regulatory Inspections 2018 Pharmacie - Médecine - Bio-Technologies - Santé Publique
healthcare, education training
Tout public, Quality Control Quality Assurance Senior Management Project Managers Qualified Persons (QPs) Regulatory Compliance CMC Personnel
50 1 --
English

Divers

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