Bad Standard Operating Procedures (SOPs) = Bad Training: Garbage In, Garbage Out

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Standard Operating Procedures (SOPs) are a vital component of ensuring compliance with regulatory agency requirements for pharmaceutical manufacturing.

Why attendees  should register:

To learn the parameters of an effective SOP
To distinguish a well-written SOP from a poorly written one
To define processes better by effective interaction with the SOP process owner and/or author

To integrate the SOP effectively into the position curricula of employees
To explore the connection between SOPs and job performance, and measure retention of SOP content at the training stage

Description of the topic:

Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform. Still, it is not widely understood how the writing of a procedure can have a positive or negative impact on training. In this course you will learn the vital connection between the documentation and training spheres, and how to maximize this connection to improve the quality of both SOPs and training.

Areas Covered in the Session:

• Regulatory requirements for SOPs - consequences for inadequate SOPs or failure to follow SOPs
• Define the parameters of an effective SOP – how your foundation keeps subsequent steps from going awry…preventing “garbage in”
          Why bad procedures have a negative impact on training
          What identifies a bad procedure
          Identify appropriate level of detail for document
•Interact with the SOP process owner/author to improve the writing of 

Using process excellence tools to create a robust process and procedure

Basics of grammar and style

How the training department needs to be in the loop at the start of the SOP development process
What SOP writers and approvers need to keep in mind for retention of the content at the training stage
•Translate the SOP into effective curriculum development and training execution
            The implications of good training for successful SOP execution
            How the SOP wording can be "translated" into language that is appropriate for learners if a presentation, computer-based training or classroom session is to be developed
•Perform an ongoing assessment of the knowledge retention of learners for continuous improvement
             Use several different methods
             Take advantage of tools that already exist in your organization
•Review of learning objectives

Who will benefit: 

Pharmaceutical industry, particularly those areas that develop SOPs for the manufacturing or quality monitoring of pharmaceutical products, as well as Information Technology (IT)

Webinar Events
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Michael Esposito, Principal, TrainReach Consulting, LLC

Michael Esposito has over 30 years experience in the pharmaceutical industry and 17 years experience in GMP training and document management. He has worked for Wyeth Pharmaceuticals, Pfizer and Johnson & Johnson's McNeil Consumer Healthcare Division in a variety of areas including Packaging, project administration, Quality Assurance, Government Contracts, translations, systems training, and international operations. He collaborated in the development and implementation of the training portion of the Consent Decree workplan for McNeil and revised their introductory GMP course. He is a member of the training organizations GMP Training Educators Association and Association for GXP Excellence and is fully fluent in Spanish. His areas of interest include systems training, training effectiveness, post-training user support, process improvement, and sustainable packaging.

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