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Overview: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.
Why should you Attend:This webinar will cover the key are

When Conducting cGMP Regulatory Inspections 2019

 

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    One Dial-in One Attendee Price: $290.00

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About The Event

 

Overview:
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.

Why should you Attend:
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.

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:
Quality Assurance
Senior management
Project Managers
Qualified Persons (QPs)
Regulatory Compliance

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.

Event Fee: One Dial-in One Attendee Price: $290.00