Proper Documentation and SOPs to Ensure Laboratory Compliance
Over 30 years of diverse international industry experience in Quality Assurance, Quality Control and Regulatory Affairs. Last 18 years as a consultant to biopharma, pharma and device industries.
- Experience has spanned from R&D to Commercial Manufacture
- 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
- Extensive experience in laboratory operations including but not limited to auditing, development of laboratory system procedures, implementation of laboratory at a new site and forensic data integrity investigations
- 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
- Expert level in Compliance and Quality System development
- Executed numerous Data Integrity assessments and remediation projects worldwide
- Ph.D. in Biochemistry, Certified as a GMP expert and in Regulatory Affairs
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 meet the regulations, it’s 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
Course Level - Beginner to Advanced
Who Should Attend
- Laboratory Operations Management
- Quality Assurance Management
- Designers of Laboratories.
Why Should You Attend
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 FDA. FDA is telling us we just don’t get it. As such we must look at what does proper documentation look like.