2-Day Seminar
2-Day Seminar

NOVEMBER 7 - 8 | MICHAEL ESPOSITO


$1200 

Seminar Registration Options: *

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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, and are a vital component of ensuring compliance with regulatory agency requirements for pharmaceutical manufacturing.

Pharmaceutical employees often do not realize that by putting their processes in writing, they are making commitments to regulatory agencies. To achieve the goal of an SOP that has adequate but not excessive detail, the course will define the parameters of an effective SOP and provide a solid foundation that will have a positive impact on training and job performance. Conversely, the negative impact of poorly written procedures on production and compliance will also be explored. To achieve these ends, the course will explain the use of process excellence tools, as well as interaction with the SOP process owner and/or author to create a robust process and procedure. In addition, the course will demonstrate how to avoid common pitfalls in revising existing procedures.

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 also 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. The training department needs to be in the loop at the start of the SOP development process, so that the SOP and training content can be written with the learner in mind, using adult learning principles and consistent terminology.

There is a relationship between SOPs, training curricula and employees’ qualification to perform their tasks. Through this course you will also learn how to integrate SOPs effectively into these curricula, which is the proof to internal auditors and regulatory agencies that job positions are correctly identified and documentation exists to demonstrate employees’ qualification to perform their tasks independently.

This course will also show you how to perform ongoing assessments of learners’ retention of knowledge of SOP content for continuous improvement and avoidance of procedural deviations, using the tools already available in your company’s training software.

Learning Objectives:
To improve the writing of SOPs for more effective training and reduction of errors.
To understand the regulatory implications of what is written in an SOP
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.


SEMINAR OBJECTIVES
WHO SHOULD ATTEND
  • Regulatory requirements for SOPs
  • Using process excellence tools to create a robust process and procedure
  • What commitments you make when you put your process in writing
  • Keeping training in mind while writing procedures
  • Consequences of noncompliance
  • Define the parameters of an effective SOP
  • How your foundation keeps subsequent steps from going awry
  • Why poorly written procedures have a negative impact on production
  • What identifies a poorly written procedure
  • Compliance risks with ambiguity or excessive detail
  • Avoiding pitfalls in revising SOPs
  • Interact with the SOP process owner/author to improve the writing of procedures
  • Integrate the SOP effectively into the position curricula of employees
  • Relationship between SOPs and employees’ training curricula
  • Why the training department needs to be in the loop at the start of the SOP development process
  • Relationship between SOPs, curricula and qualification to perform tasks
  • Retention of the content at the training stage
  • The implications of good training for successful SOP execution
  • Perform an ongoing assessment of knowledge retention of SOPs for continuous improvement
  • Review of learning objectives
  • Knowledge assessment

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
  • IT Departments
  • Management – essentially everyone in the organization who is tasked with creating or reviewing procedures


AGENDA

DAY 1 (9 AM to 4 PM)

09:00 AM - 10:00 AM Session 1

  • Seminar objectives review, expectations and scope.
  • Interview attendees re their specific
  • responsibilities and needs
    Agreement on focus

10:00 AM - 11:00 AM Session 2

  • Regulatory requirements for SOPs
  • What commitments you make when you put your process in writing
  • Consequences of noncompliance
  • Review or knowledge check

11:00 AM - 01:00 AM Session 3

  • Parameters of an effective SOP (scope, length, conciseness, responsibilities)
  • Distinguishing good SOPs from poor SOPs
  • Practice exercise

    * includes lunch break

01:00 PM - 02:00 PM Session 4

  • Using process excellence tools to create a robust process and procedure
  • Brief process excellence exercise using areas of expertise in room

02:00 PM - 03:00 PM Session 5

  • Pulling out the process from process owners and subject matter experts
  • Simulation of interview with stakeholders
  • Revision of procedures – avoiding pitfalls
  • Brief exercise to revise a process

03:00 PM - 04:00 PM Session 6

  • Keeping training in mind while writing procedures
  • Simulation of a discussion between training and documentation
  • Attendee practice
  • Knowledge check for day


DAY 2 (9 AM to 4 PM)

09:00 AM - 11:00 AM Session 7

  • Seminar objectives review, expectations and scope
  • Review of Day 1 topics, feedback and conclusions
  • Relationship between SOPs and training curricula
  • Basics of training curricula
  • Structuring courses and modules
  • Demo of creating a curriculum with existing SOPs

11:00 AM - 01:00 PM Session 8

  • Exercise in creating training curricula with existing SOPs – breakout groups and flip charts
  • Group review

    * includes lunch break

01:00 PM - 02:00 PM Session 9

  • Curriculum completion and qualification to perform tasks
  • Special circumstances of systems training roles and curricula
  • Demo and practice of evaluating qualification

02:00 PM - 04:00 PM Session 10

  • Measurement of SOP and training effectiveness (e.g. knowledge assessment questions)
  • Tools in Learning Management Systems (LMSs)
  • How you as an SOP writer can access these tools
  • Exercise in evaluating training data
  • Course review
  • Questions and feedback
  • Knowledge assessment


COURSE DIRECTOR: MICHAEL ESPOSITO

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.