Course "Writing and implementing effective SOP's" has been pre-approved by An SOP is a meticulous step-by-step description of how to do a task that leave 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 specific unique to that laboratory

RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

An SOP is a meticulous step-by-step description of how to do a task that leave 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 specific unique to that laboratory. Writing, implementing, maintaining and assessing, revising an SOP are all different and necessary jobs. Many people must continuously be involved in these steps.

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 an 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.

Why should you attend:

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?

Who will benefit:

·Anyone that creates / maintains SOPs

·VP, Director, Manager of any dept that writes SOPs or performs training

·QA / QC

·Regulatory Affairs

Agenda:

Day 1 Schedule

Lecture 1: What is the intention and role of SOPs. What tasks require SOPs? The network of SOPs within the Lab.

Lecture 2: What are the compliance requirements for an SOP? Roles and responsibilities. Can a Standard method be used as an SOP?

Lecture 3: Creating an SOP. For a new task. For a Standard method. Reviewing the first attempt.

Lecture 4: Creating an SOP. For a new task. For a Standard method. Reviewing the first attempt (continued)

Day 2 Schedule

Lecture 1: Interplay within the lab to improve the draft SOP. Iterations?

Lecture 2: Implementation of the SOP.

Lecture 3: Monitoring and Assessing the SOP. When should an SOP be revised? Revising the SOP.

Lecture 4: Archiving and documentation. Which SOP to use when? Other requirements.

Speaker:

John C. Fetzer,

Founder and Principal, Consultant Fetzpahs Consulting

John C. Fetzer, has had over 30 year experience in HPLC methods development. He has authored or co-authored over 50 peer-reviewed papers on liquid chromatography, has served on the editorial advisory boards of the Journal of Chromatography, Analytical Chemistry, and Analytical and Bio analytical Chemistry.

Location: Baltimore, MD Date: September 21st & 22nd, 2017 and Time: 9:00 AM to 6:00 PM

Venue: The DoubleTree Baltimore-BWI Airport 890 Elkridge Landing Road - Linthicum, MD 21090

Price:

Register now and save $200. (Early Bird)

Price: $1,295.00 (Seminar Fee for One Delegate)

Until August 10, Early Bird Price: $1,295.00 From August 11 to September 16, Regular Price: $1,495.00

Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*

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