When Conducting cGMP Regulatory Inspections 2018

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Category CGMP Regulatory Inspections, cgmp guidelines 2018, good laboratory practices, Compliance Online Standards, FutureTrends, gmp in pharmaceutical industry

Deadline: August 14, 2018 | Date: August 16, 2018

Venue/Country: Online, U.S.A

Updated: 2018-06-07 14:34:03 (GMT+9)

Call For Papers - CFP

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: supportcompliance4All.com