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

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

"Michael Esposito has over 30 years experience in the pharmaceutical industry and 17 years experience in GMP training and document management"

How to maximize this connection to improve the quality of both SOPs

Description

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.

Why should you attend

•     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 authorTo 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
•     To explore the connection between SOPs and job performance, and measure retention of SOP content at the             training stage

Areas Covered

 •     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 procedures

      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 objective

Who will Benefit

•     Documentation Specialist
•     Documentation Manager
•     Technical Writer
•     Trainer
•     Training Manager
•     Quality Assurance Specialist
•     Quality Assurance Manager

Industries who can attend

This 90-minute online course is intended for professionals in the Pharmaceutical, Clinical Data Management SaaS companies, and medical device companies . Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Michael Esposito

Michael Esposito has over 30 years experience in the pharmaceutical industry and 18 years experience in GMP training and document management. He has worked for Wyeth Pharmaceuticals, Pfizer and Johnson & Johnson's 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 Johnson & Johnson Consumer Healthcare 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, product security, and sustainable packaging.

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