Combination Drug/Device Products CGMPs - Final Rule 2015

  • 08 Apr 2015
  • Webinar

Description

Combination Drug/Device Products CGMPs - Final Rule 2015 is a webinar that covers topics such as:

  • The CGMP "Operating System"
  • The Four Basic Types of Combination Products - physically combined, two or more of device, drug, biologic, packaged separately but intended for use only with another, different type of medical product ("cross-labeling") and packaged together
  • Applicability of 21 CFR 210/211, 600-680, 820, and 1271
  • Constituent Parts
  • Single-type Constituent Part Facilities
  • The Two Ways to Compliance
  • How to Address CGMP "Conflict"

Combination Drug/Device Products CGMPs - Final Rule 2015 is intended for attendees from pharmaceutical, medical device, and biologics fields, including:

  • Regulatory affairs
  • Senior management
  • Production
  • Quality assurance
  • All personnel involved in a U.S. FDA-regulated environment; especially those involved in CGMP compliance of affected regulated combination medical products
  • Engineering

Past Events

Important

Please, check "Combination Drug/Device Products CGMPs - Final Rule" official website for possible changes, before making any traveling arrangements

Event Categories

Health & Medicine: Medical device, Pharma
Science: Life Sciences & Biology

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