Although applicable to any laboratory across the world, this webinar will discuss the following as it relates to the operation of a compliant quality control laboratory in a US FDA regulated environment including Regulations and Guidance Overview, SOPs to Ensure Compliance, Types of Procedures, and Electronic Record Keeping.
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. As such one must look at what does proper documentation look like. This presentation will review the regulations related to documentation, some sample citations, and typical procedures found in laboratory operations and then we will propose a way to build better documentation.
With laboratory documentation, or lack thereof, continuing to be a focus of regulatory citations it is important to identify what makes for good laboratory documentation. This webinar will teach you that it’s not just having the procedures, but that the procedures are written in such a way that they ensure consistency of execution of the processes they are purported to be about. Participants will learn current regulatory thinking, examine typical procedure elements and contrast them with well written procedures. A list of suggested procedures every laboratory should have at a minimum will be included. Participants will also be provided with a sample Test execution and review procedure that they can implement for managing testing in their laboratory.
- Laws, Regulations and guidance applicable to laboratory operations
- Code of Federal Regulations
- FDA mode of thinking
- Example Laboratory Warning Letter citations
- Typical Procedures
- Industry examples
- Elements of a Good Procedure
- Process Flow Discussion
- Discussion of what is the purpose of each section and what type of info should go in each section.
- Types of Procedures
- Minimum procedures for a well-run laboratory
- Management of Records
David Husman Consulting LLC
- 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.