10times
29 - 30 Mar 2021

Quality and GMP Compliance for Virtual Companies

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Timings

09:00 AM - 06:00 PM
Not Verified

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Estimated Turnout

100 - 500
Delegates
Based on previous editions

Editions

Mar 2021
+2 more editions

Frequency

Quarterly
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This training will be highly beneficial for virtual companies. By attending this seminar you will understand FDA, EMA, and Health Canada’s .. Read more inspection, GMP and GLP requirements. “The Compliance Certification Board (CCB)® has approved this event for up to 9.6 live CCB CEUs. Companies who outsource the majority of operations through the use of Contract Manufacturing Organizations (CMOs), Contract Research Organizations (CROs) and Contract Laboratories, however, remain responsible for the quality and compliance status of the products they send to the clinic or to the marketplace. In this two day workshop conference you will learn the requirements and expectations of major health care regulators that are applicable to "virtual" companies. You will learn how to diagnose your company's needs based on which GMP and GCP-governed operations you retain and which you outsource; what the current expectations and best industry practices are for selecting, qualifying and monitoring your contractors to ensure they are meeting your requirements; and how to build a quality system framework that is not excessive for your current needs, but has the structure and integration to "grow with you" as the scope your operations change in the coming months and years. You will also learn best practices for managing a regulatory inspection, with emphasis on FDA, EMA and Health Canada, but applicable to most other major agencies as well.

3   Different Located Editions
Burlingame, USA20 - 21 Feb 2020
1 Followers
Irvine, USA17 - 18 Oct 2019
5 Followers
San Diego, USA20 - 21 Jun 2019
KANNAN M

KANNAN M

Managing Director at A1. PHARMA

Panruti, India
Evans Nartey

Evans Nartey

Safety Consultant at Evans Safety Academy

Accra, Ghana
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