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Faculty: Michael Esposito ‎ ‎ ‎ ‎ ‎‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ Code: FDB3584

  • Date: 1/8/2024 11:00 AM - 1/8/2024 02:00 PM
  • Time zone: Eastern Time (US/Canada) Online Event


Standard Operating Procedures (SOPs) are necessary to demonstrate compliance with regulations and operational practices. It also serves as a documented roadmap which ensures consistency. This is integral to a strong quality system. If you want to improve SOPs writing and training materials that create more effective training as well as help in the reduction of errors, this webinar is for you.

  • Learn to define the parameters of an effective SOP
  • How your foundation keeps subsequent steps from going awry-preventing “garbage in”
  • What interactions are necessary with the SOP process owner/author to improve the writing of procedures •
  • How can we translate the SOP into effective curriculum development and training execution
  • Considerations related to curricula and Learning Management Systems (LMSs) o 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

Areas Covered in the Session :

  • 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
    • 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 Should Attend:
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.

  • Pharmaceutical industry- particularly those areas that develop SOPs for the manufacturing or quality monitoring of pharmaceutical products, which would also include Information Technology (IT) employees who manage systems training
  • Quality Departments
  • Production Departments
  • Compliance Departments
  • Engineering Departments
  • R & D Departments
  • Management – essentially everyone in the organization who is tasked with creating or reviewing procedures


Michael Esposito has 30 years experience in the pharmaceutical industry and 13 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 organization GMP TEA and is fully fluent in Spanish. His areas of interest include systems training, training effectiveness, post-training user support, process improvement, and sustainable packaging.