Writing and implementing effective SOP’s

[John Robinson]

Utmost thoroughness and diligence need to go into writing and implementing effective SOP’s. This is because Standard Operating Procedures are to be designed keeping the exact and fullest details of the task that is to be described. It is a very detailed art as it has to take everything into consideration and leave nothing to chance.

Even the smallest errors or discrepancies or divergences can lead to problems with the product usage. In the context of a laboratory, even with all the details that are standard; details pertaining to the exact situation of the laboratory need to be described. An SOP for even a standardized method such as ASTM or IP can be written insufficiently.

Writing is just one part of the job

If writing an SOP is one job; implementing it is another. Maintaining and assessing are yet other parts of the job. And then, there is the task of revising the SOP if needed. All these are related jobs, but are independent of each other and require different sets of people with their own qualifications and experience to handle.

The need for writing SOPs effectively is best understood in light of the fact that a poorly written and enforced one is among the most common cases of noncompliance that auditors detect.

A seminar on getting writing of SOPs right

The ways of implementing the correct means of writing SOPs for a laboratory will be taught at a seminar that GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing.

The seminar will have John C. Fetzer, who is Founder and Principal Consultant, Fetzpahs Consulting, as Director. John brings over 30 years of experience in HPLC methods development. He has authored or co-authored over 50 peer-reviewed papers on liquid chromatography and has served on the editorial advisory boards of the Journal of Chromatography, Analytical Chemistry, and Analytical and Bio analytical Chemistry.

To gain clear understanding of how to write SOPs that are effective in both helping those working in the laboratory understand how to put it to effective use and are capable of passing compliance requirements, please enroll for this seminar by visiting Writing and implementing effective SOP’s. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Description of all the steps

At this seminar, John will describe the complex, but necessary steps both within the laboratory and within the supporting areas for implementation and revision of an SOP. Recordkeeping, safety and training are some of these steps.

John will also describe the reasons for which even standardized methods get insufficiently written. He will explain the steps needed to convert a standard method into an SOP. Laboratory workers, supervisors, managers of a laboratory seeking or under GLP or ISO 17025, and other involved in SOPs, such as Research Associates, Lab Chemists, Lab Supervisors and Quality Officers will derive high value from this seminar.

Over the two days of this seminar, John will cover the following areas:

o  What is the intention and role of SOPs? What tasks require SOPs? The network of SOPs within the Lab

o  What are the compliance requirements for an SOP? Roles and responsibilities. Can a Standard method be used as an SOP?

o  Creating an SOP. For a new task. For a Standard method. Reviewing the first attempt

o  Creating an SOP. For a new task. For a Standard method. Reviewing the first attempt (continued)

o  Interplay within the lab to improve the draft SOP Iterations?

o  Implementation of the SOP

o  Monitoring and Assessing the SOP. When should an SOP be revised? Revising the SOP.

o  Archiving and documentation. Which SOP to use when? Other requirements.