2019 - Proper Documentation and SOPs to Ensure Laboratory Compliance

OVERVIEW
The goal of laboratory documentation should be to ensure compliance. However, failures in documentation and procedures represent more than half of the top citations by the FDA. As such one must look at what does proper documentation look like. This presentation will review the regulations, citations, and typical procedures found in laboratory operations, and then propose a way to build better documentation.
LEARNING OBJECTIVES
What laboratory documentation is required for compliance?
What are typical citations as it relates to laboratory documentation?
With forethought and design, good procedures are possible
Good documentation and record integrity ensure good compliance
WHY SHOULD YOU ATTEND
Regulations and guidance overview
SOPs to ensure compliance
Types of procedures
Electronic record-keeping
AREAS COVERED
Laws, Regulations, and guidance applicable to laboratory operations
It's not just about to meet the regulations, it is getting the processes to achieve business needs
Process mapping approach to designing a sample executable laboratory operations SOP
WHO WILL BENEFIT?
Laboratory operations management
Quality Assurance management
Designers of laboratories
SPEAKER
David Husman has over 30 years of diverse international industry experience in Quality Assurance, Quality Control, and Regulatory Affairs. He has worked for last 18 years as a consultant to biopharma, pharma, and device industries.
David's experience has spanned from R&D to Commercial Manufacture.
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