WRITING AND IMPLEMENTING A STANDARD OPERATING PROCEDURE (SOP) IN A COMPLIANT LABORATORY (US FDA, US EPA AND OSHA FOCUS)

About The Course:

This seminar will describe the requirements, the dos and don’ts commonly performed by laboratories, the writing of a Standard Operating Procedure (SOP), and ways to ensure that it is followed, up to date, and archived properly.

The SOP is one of the core elements within a compliant laboratory. Any action in the laboratory must be done by following an SOP, no matter how common or seemingly trivial the action might be. Under GLP or ISO 17025, the SOP must guide those doing the tasks in such detail that there are no chances of unacceptable variation, any chance of a non-compliance. This is a very high bar to meet.

A poorly written and followed SOP is one of the most common non-compliances that an auditor finds. If you are a laboratory worker, a supervisor, or manager of a laboratory seeking or under GLP or ISO 17025, you should know how to create and maintain a good SOP. Will your SOPs pass an audit or will they become a non-compliance corrective action?

An SOP is a meticulous step-by-step description of how to do a task that leaves no chance for errors and divergence. Writing a good SOP is not an easy job. It requires a firm understanding of the task to be described, an ability to describe in specifics that are unique to that laboratory. Writing, implementing, maintaining, assessing, and revising an SOP are all different and necessary jobs. Many people must continuously be involved in these steps. The individual roles will be described for each.

Even a standardized method, such as an ASTM or IP method, is insufficiently written to pass as a well-written and compliant SOP. The reasons why will be described, as will the steps needed to convert a standard method into a compliant SOP.

The necessary steps both within the laboratory and within the supporting areas for implementation and revision of an SOP are complex and will be described. These include recordkeeping, safety, training, and other areas.

Seminar Objectives:

Upon completing this course, participants should:

• Know the roles within the laboratory of each individual in creating, implementing, monitoring, training, documenting, and updating an SOP.
• Understand how the tasks in a methodology define the structure and detail in the SOP.
• Understand the interrelationship of SOPs and how to incorporate those into a method SOP.
• Know a cross-training approach to assess possible variation.
• Know how to implement updates and when to changes are sufficient for a revalidated new version of the protocol.
• Know the requirements and possible protocols for archiving.

Who Should Attend:

This course is aimed at those working in laboratories that must comply with Good Laboratory Practice or ISO 17025, especially those whose results are to be reported to the US Food and Drug Administration (FDA), the US Environmental Protection Agency (EPA), and the US Occupational Safety and Health Administration (OSHA). A must-attend course for:

• Every Laboratory Professional
• Quality Assurance Departments
• Quality Control Departments
• Research and Development Departments
• Scientists
• Research Associates
• Internal Auditors

DAY 1 (12 PM to 4 PM)

Session 1:

• What is the intention and role of SOPs?
• What tasks require SOPs?
• How the network of SOPs within the Lab support each other?
• How is an SOP structured/ formatted?

Session 2:

• What are the compliance requirements for an SOP?
• Descriptions of the roles and responsibilities of people in the SOP process.

Session 3:

• Description of the various standard methods.
• The Regulatory Compliance Method.
• The Scientific Published-Literature Method.
• The Industrial Standard Method (ASTM and ISO methods).
• How to assess if a standard method can be used as is as the SOP?
• Conversion to an acceptable SOP from a standard method.

Session 4:

• How to create an SOP?
• The SOP for a new task.
• The SOP for a new methodology.
• The SOP for a Standard method.

DAY 2 (12 PM to 4 PM)

Session 5:

• The Interplay within the lab to improve the draft SOP.
• Reviewing the first attempt.
• Iterations and how to assess the reaching of compliance.

Session 6:

• The Implementation of the SOP.
• Training, The Documentation of Initial Training and the On-Going Proficiency testing as a Requirement.

Session 7:

• Monitoring and Assessing the SOP for Needs of Changes.
• Modification, Updating, and Revising an SOP. When should an SOP be revised?
• Revising the SOP and Its Documentation and Approval.
• The Use of a Method Timeline to Track Changes.

Session 8:

• The Requirements in Archiving and Documentation.
• Which SOP is to be used when?
• Other requirements that must be included: Facility requirements, purchasing guidelines, safety issues methods of reporting (and standard forms and information to be reported).