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

Duration: 90 Minutes
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.
Writing Good Standard Operating Procedures
Instructor: Michael Esposito
Product ID: 506162
Objectives of the Presentation
  • Define the parameters of an effective SOP
  • How your foundation keeps subsequent steps from going awry…preventing "garbage in"
  • Interact with the SOP process owner/author to improve the writing of procedures
  • Translate the SOP into effective curriculum development and training execution
  • Considerations related to curricula and Learning Management Systems (LMSs)
  • Considerations for training: reading of SOPs with assessments and/or classroom training
  • Perform an ongoing assessment of the knowledge retention of learners for continuous improvement
Why Should you Attend
To improve the writing of both SOPs and training materials for more effective training and reduction of errors.

Areas Covered
  • Regulatory requirements for 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 procedures
  • 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
This course will be of benefit to anyone who is an owner of a process, responsible for writing or reviewing procedures, and/or managing training in a GMP environment.
  • Quality
  • Production
  • Compliance
  • Engineering
  • R & D
  • Management - essentially everyone in the organization that is tasked with creating regulatory documentation
$200
Recorded Session for one participant
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  $250.00 Training CD
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
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 Consumer Healthcare Division (formerly McNeil)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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