Writing and Implementation of Good Standard Operating Procedures (SOPs)
John C. Fetzer has had over 30-years experience in laboratory compliance, including developing methods, writing SOPs, training, and auditing. He has served on the editorial advisory boards of the Journal of Chromatography, Analytical Chemistry, and Analytical and Bioanalytical Chemistry.
An SOP can be the cause of numerous non-compliance citations during an audit. Each can lead to other non-compliances so that each SOP can be either a solid footing or building the laboratory’s work on quicksand. Writing a good SOP is not difficult, but it is time-consuming. Documentation and reviews must be made. Responsibilities for implementation and maintenance must be laid out. Recordkeeping must be done and archived.
- The SOP requirements
- What makes an acceptable SOP?
- documentation of the SOPs
- Roles in SOP maintenance and Modification
- Training and Proficiency
Course Level - Intermediate or Advanced
Who Should Attend
- Lab Chemists
- Lab Managers
- Lab Technicians
- Lab Analysts
- Industries into Compliance Methodology (Biotech, Pharma)
Why Should Attend
Every task in a compliant laboratory must be run with exactitude. This is met by having well-written standard operating procedures (SOPs) for each and every task. The individual SOP must be very detailed, enough so that any person can follow the described steps and get acceptable results. The SOPs must be distinct and kept updated as the methodologies are improved and changed. In this, there must be a designation of the specific SOP version used, where documentation is structured and maintained to ensure that only the appropriate version is ever used.
Companies into Environmental Compliance or EPA.