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Aug
25

Managing GMP Compliance and Phase Appropriate GMP Considerations for Virtual Companies

 
 Seminar/trade show (noCPF)

When:

  25 Aug through 26 Aug 2021

Where:

  Online Event | United States

Website URL:

  https://www.complianceonline.com/fda-gmp-expectations-phase-i-first-in-man-clinical-trials-iso-9001-2015-qms-cmc-seminar-training-80366SEM-prdsm?channel=Brownwalker

Sponsoring organization:

  Compliance Online

Categories:

  Medicine & Health - Pharmaceutical / Medicinal

Keywords:

Event description:

This program combines general considerations for Good Manufacturing Practice (GMP) compliance management with the principles of phase-appropriate GMP considerations, with an emphasis on needs of virtual companies. (“Virtual companies” are those who outsource GMP operations to Contract Manufacturing Organizations (CMOs) and Contract Analytical Laboratories.) Virtual companies typically do not conduct “hands on” manufacturing, but do perform tasks which are governed by GMP, for example, dispositioning final product, managing the supply chain, investigating complaints, and providing training to staff in GMP compliance concepts. Such companies often struggle to decide how to structure their quality management system, which procedures they need or do not need, and how to best manage vendor relationships. In addition, the application of GMP requirements to the manufacture of investigational products requires exercise of judgement over the life cycle from early phase (Phase 1) to peri-a... Read more

Posting date:

16 August 2021  |  187 views

Placement:

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