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 the extent of the commitments we make when we write an SOP or how the writing of the SOP can have a positive or negative impact on training or job performance. For example, there is an expectation that procedures describe the most critical processes for product manufacturing and will be followed consistently, with few if any deviations. In this course you will learn the keys to writing effective SOPs, the vital connection between the documentation and training spheres, and how to maximize this connection to improve the quality of both SOPs and training.

To accomplish these goals, we will review regulatory agency expectations when an SOP is written, provide suggestions for uncovering the process in its entirety and describe it clearly and concisely, indicate how to break portions of the process(es) into logical chunks, and show how the SOP and the training program can work together harmoniously.

Understanding how the average employee is swamped with more work than they can manage, we will also provide tips for shortening this process and take advantage of tools that probably already exist in the systems that you use on a day-to-day basis. We will provide valuable insights and examples that reflect the extensive experience of the instructor in the documentation and training fields., and which can assist you in writing and implementing SOPs with maximum efficiency and effectiveness.

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

Areas Covered :

  • 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

In-Person Seminar going Virtual with increased learner satisfaction.

Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:

Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:

  • The real-time and live presentation as in in-person events
  • Private chat for company-specific conversation – the same as you would get in an in-person seminar
  • Opportunities to connect with your peers to share knowledge at a different time and have group discussions
  • Live workshop activities
  • Live Q&A during the event and offline Q&A assistance after the event
  • As usual more content, activities and case studies and now adding homework for a comprehensive understanding
  • Certification
  • 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
  • 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
  • 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
  • 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)

    Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
    Day 01(9:00 AM - 4:30 PM PDT)
    • 09.00 AM - 10.00 AM:
      • Seminar objectives review, expectations and scope.
      • Interview attendees re their specific responsibilities and needs
      • Agreement on focus
    • 10.00 AM - 11.00 AM:
      • 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 - 12.00 PM:
      • Parameters of an effective SOP (scope, length, conciseness, responsibilities)
      • Distinguishing good SOPs from poor SOPs
      • Practice exercise
    • 12.00 PM - 01.00 PM: Lunch
    • 01.00 PM - 02.00 PM:
      • 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:
      • 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:
      • Keeping training in mind while writing procedures
      • Simulation of a discussion between training and documentation
      • Attendee practice
    • 04.00 PM - 04.30 PM:
      • Knowledge check for day
    Day 02(0:00 AM - 4:30 PM PDT)
    • 09.00 AM - 10.00 AM:
      • Seminar objectives review, expectations and scope.
      • Review of Day 1 topics, feedback and conclusions
    • 10.00 AM - 11.00 AM:
      • 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 - 12.00 PM:
      • Exercise in creating training curricula with existing SOPs - breakout groups and flip charts
      • Group review
    • 12.00 PM - 01.00 PM: Lunch
    • 01.00 PM - 02.00 PM:
      • Curriculum completion and qualification to perform tasks
      • Special circumstances of systems training roles and curricula
      • Demo and practice of evaluating qualification
    • 02.00 PM - 03.00 PM:
      • 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
    • 03.00 PM - 04.00 PM:
      • Course review
      • Questions and feedback
    • 04.00 PM - 04.30 PM:
      • Knowledge assessment
    Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
    Michael Esposito

    Michael Esposito
    Principal, TrainReach Consulting, LLC

    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 work plan 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.

    Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

    Register Now

    Online using Credit card

    $1,699.00

    (One Dial-in One Attendee)

    October 25-26, 2021, Virtual Seminar

    $8,665.00

    Group-Max. 10 Attendees

    October 25-26, 2021, Virtual Seminar



    Other Registration Option

    By order form / PO#

    Payment Mode

    By Check -
    Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

    ComplianceOnline (MetricStream, Inc),
    6201 America Center Drive Suite 240
    San Jose, CA 95002
    USA

    By Wire -

    Register / Pay by Wire Transfer

    Please contact us at +1-888-717-2436 to get details of wire transfer option.

    Terms & Conditions to Register for the Seminar/Conference/Event

    Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ [email protected]

    Payment:

    Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

    Cancellations and substitutions for In-person Seminars:

    Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

    On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

    Substitutions may be made at any time. No-shows will be charged the full amount.

    We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

    In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

    Cancellations and Substitutions for Virtual Seminars & Webinars:

    Written cancellations through fax or email (from the person who has registered for the training) received at least 10 calendar days prior to the start date of the event will receive a refund — less a 30% administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event. On request by email or fax (before the training) a credit for the amount paid minus administration fees (30%) will be transferred to any future ComplianceOnline event and a credit note will be issued. Substitutions may be made at any time. No-shows will be charged the full amount. Some topics and speakers may be subject to change without notice.
    Offers:
  • Early bird seats are limited and based on first-come, first-serve.
  • Multiple offers cannot be combined.
  • We need below information to serve you better

     

    +1-888-717-2436

    6201 America Center Drive Suite 240, San Jose, CA 95002, USA

    Follow Us

    facebook twitter linkedin youtube

     

    Copyright © 2021 ComplianceOnline.com MetricStream
    Our Policies: Terms of use | Privacy

    PAYMENT METHOD: 100% Secure Transaction

    payment method