Proper Documentation and SOPs to Ensure Laboratory Compliance

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.

• 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

• 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
• Steps necessary to ensure existing laboratory and new laboratories have processes implemented that ensure compliance

• Regulations and guidance overview
• SOPs to ensure compliance
• Types of procedures
• Electronic record-keeping

• Laboratory operations management
• Quality Assurance management
• Designers of laboratories

• 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.
• His background includes, but not limited to, parenteral products, human tissue products, blood products, biotech products, solid dosage, vaccines, implantable devices, and in vitro diagnostic products for both human and animal species.
• His extensive experience in laboratory operations includes but not limited to auditing, development of laboratory system procedures, implementation of laboratory at a new site and forensic data integrity investigations.
• He has experience in all parts of the manufacturing operation from warehousing to packaging, from facilities and utilities to laboratories to computer systems, from regulatory to quality control. 
• He has an expert level knowledge in Compliance and Quality System development.
• He has executed numerous Data Integrity assessments and remediation projects worldwide.
• He is also a Ph.D. in Biochemistry, and is certified as a GMP expert and in Regulatory Affairs.