Proper Documentation and SOPs to Ensure Laboratory Compliance 2021

Proper Documentation and SOPs to Ensure Laboratory Compliance 2021

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.

Areas Covered in the Webinar:

• 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
  • Organization
  • Voice
  • 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 –
  • Paper
  • Electronic

Who Will Benefit:

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