Compliant Laboratory 2021 - Live Webinar Building a Compliant Laboratory – From Foundation to Business Excellence

Compliance in laboratory settings has been a topic for FDA and other regulators for decades. With the increased focus on data integrity and continued focus on laboratory investigations, it is critical more than ever to ensure you have designed your laboratory operations system to meet the compliance needs of your business
In this presentation I will define compliance, provide a translation of regulations and guidance into user requirements and then using those user requirements show how one can design a laboratory system. Finally, I will provide a roadmap for implementation whether an existing laboratory or a new laboratory.
Common understanding of compliance
Laws, Regulations and guidance applicable to laboratory operations
Translation of thou shalt into system requirements
Speaker:
Over 30 years of diverse international industry experience in Quality Assurance, Quality Control and Regulatory Affairs. Last 20 years as a consultant to biopharma, pharma and device industries.