Two-day online seminar: Writing and implementing a standard operating procedure (SOP) in a compliant laboratory: US FDA, US EPA and OSHA Focus


Dublin, December 22, 2021 (GLOBE NEWSWIRE) – The “Writing and implementing a standard operating procedure (SOP) in a compliant laboratory (US FDA, US EPA and OSHA Focus)” training has been added to ResearchAndMarkets.com offer.

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

The SOP is one of the essential elements within a compliant laboratory. Any action in the lab should be performed following a SOP, no matter how common or seemingly insignificant the action may be. Under GLP or ISO 17025, the SOP must guide those performing the tasks in such detail that there is no chance of unacceptable variation, no chance of non-compliance. It is a very high bar to respect.

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

An SOP is a meticulous, step-by-step description of how to perform a task that leaves no chance for errors and discrepancies. Writing a good SOP is no easy task. It requires a solid understanding of the task to be described, an ability to describe in the details that are unique to this laboratory. Writing, implementing, maintaining, evaluating and reviewing an SOP are different and necessary tasks. Many people must be continually involved in these stages. Individual roles will be described for each.

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

The steps required both within the laboratory and in the support areas for the implementation and revision of a SOP are complex and will be described. These include record keeping, security, training and other areas.

Learning objectives:

  • Know the roles within the laboratory of each individual in the creation, implementation, monitoring, training, documentation and updating of a SOP.

  • Understand how the tasks of a methodology define the structure and details of the POS.

  • Understand the interrelation of SOPs and how to incorporate them into a SOP method.

  • Know a cross-training approach to assess possible variations.

  • Know how to implement updates and when the changes are sufficient for a new, revalidated version of the protocol.

  • Know the requirements and possible protocols for archiving.

Main topics covered:

Day 01 (9:30 a.m. – 5:30 p.m. EST)

Session 1 (90 minutes)

  • What is the intention and role of SOPs?

  • What tasks require SOPs?

  • How does the SOP network within the Lab support itself?

  • How is a SOP structured / formatted?

Session 2 (90 minutes)

Session 3 (90 minutes)

  • Description of the different standard methods.

  • The method of regulatory compliance.

  • The method of published scientific literature.

  • The standard industrial method (ASTM and ISO methods).

  • How to assess whether a standard method can be used as is as an SOP?

  • Converting to an acceptable SOP from a standard method.

Session 4 (90 minutes)

Day 02 (9:30 a.m. – 5:30 p.m. EST)

Session 1 (90 minutes)

  • Interaction within the laboratory to improve the SOP project.

  • Review the first try.

  • Iterations and how to assess the achievement of compliance.

Session 2 (90 minutes)

  • The implementation of the SOP.

  • Training, documentation of initial training and continuing proficiency testing as a requirement.

Session 3 (90 minutes)

  • POS monitoring and evaluation for changes.

  • Modification, update and revision of an SOP. When should a SOP be reviewed?

  • Review the POS, its documentation and approval.

  • Using a method timeline to track changes.

Session 4 (90 minutes)

  • Archiving and documentation requirements.

  • Which SOP should be used when?

  • Other requirements that should be included: facility requirements, purchasing guidelines, methods of reporting safety concerns (and standard reporting forms and information).

For more information on this training, visit https://www.researchandmarkets.com/r/izb461

CONTACT: CONTACT: ResearchAndMarkets.com Laura Wood, Senior Press Manager [email protected] For E.S.T Office Hours Call 1-917-300-0470 For U.S./CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900


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