The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: June 10, 2021 at 11am to June 11, 2021 at 5pm
Street: Compliance Online, 2479 E. Bayshore Road
City/Town: Palo Alto
Website or Map: https://www.complianceonline.…
Event Type: seminae
Organized By: ComplianceOnline
Latest Activity: May 23, 2021
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.
Participants in this seminar will:
This course is designed for those charged with managing Quality Assurance and Regulatory Affairs for companies in the development or commercial phase of growth who either release investigational drugs to clinical trial sites or send commercial products to the market, but rely to a great extent on the use of Contract Manufacturers and/or Contract Laboratories. The following personnel will benefit from the course: