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,
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.