2-Day Virtual Seminar on SOP Writing, Training and Compliance in the Pharmaceutical Industry

  • Product Id : SEM2886
  • Category :
  • Presenter :
  • Scheduled On : January 31 2022 9:00 am
  • Duration : 2 Days

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

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
    • 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

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

SEM2886

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.

DAY 1 : (11 AM – 4 PM)

Session 1
– Seminar objectives review, expectations and scope.
– Interview attendees re their specific responsibilities and needs
– Agreement on focus

Session 2
– Regulatory requirements for SOPs
– What commitments you make when you put your process in writing
– Consequences of noncompliance
– Review or knowledge check

Session 3
– Parameters of an effective SOP (scope, length, conciseness, responsibilities)
– Distinguishing good SOPs from poor SOPs
– Practice exercise

Session 4
– Using process excellence tools to create a robust process and procedure
– Brief process excellence exercise using areas of expertise in room

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

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 : (11 AM – 4 PM)

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

Session 8
– Exercise in creating training curricula with existing SOPs – breakout groups and flip charts
– Group review

Session 9
– Curriculum completion and qualification to perform tasks
– Special circumstances of systems training roles and curricula
– Demo and practice of evaluating qualification

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

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 at +1-416-915-4458 or email us at info@webinarcompliance.com

Payment Policy:

Payment is required to be made at least 2 business days prior to the date of the conference. We accept American Express, Visa and MasterCard.

To make payment by Wire Transfer, kindly call our Customer Support to assist you with completing your registration. Registrations by Wire are required to be made at least 7 business days before the date of the conference. Payments to be made in full.

To make payment through a check, please draw a check to FutureCorp Consulting INC. (our parent company), and kindly call Customer Support to assist you further. Registrations by Check payments are required to be made at least 12 days before the date of the conference. Your check needs to be cleared before your registration is confirmed. A letter of confirmation (along with an electronic event pass) will be e-mailed to you once payment is received. Payments to be made in full. Post-dated checks shall not be accepted.

Customer Support: +1-416-915-4458
Email: info@webinarcompliance.com

Attendance Confirmation and required documents:

After we receive the payment from the registered attendee, an electronic event pass (eTicket) will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the event venue.

Substitution Policy:

If a registered delegate is unable to attend, substitutions can be made at any time at the prevailing rate. However, it has to be confirmed a day prior, in writing with proper identification of the substitute person you plan to send on your behalf. No show will be charged the complete amount.

On-the-spot Registration:

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

Cancellation & Refund Policy:

Written cancellations through 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 – minus 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 (before the seminar) a credit for the amount paid minus administration fees ($300) could be transferred to any future Compliance Trainings event and a credit note will be issued.

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

Compliance Trainings reserves the right to change/modify some topics, material or speakers/instructors without notice.

If an event dates and/or venue is changed/cancelled, registrants are required to opt for alternate dates and/or venue provided by Compliance Trainings.

If an event is cancelled altogether, without alternate dates or venue, Compliance Trainings will issue a full refund.

Compliance Trainings will not be responsible for travel/accommodation or any other costs incurred due to changes/cancellation.

Compliance Trainings reserves the right to change event/seminar dates, venues or cancel altogether. Registrants will be notified by Compliance Trainings in writing as soon as possible.

Compliance Trainings will not be responsible for travel/accommodation or any other costs incurred due to changes/cancellation.

Conference photograph / video:

By registering and attending Compliance Trainings conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to Compliance Trainings using these photos and videos for marketing, archiving or any other conference related activities. You agree to release Compliance Trainings from any kind of claims arising out the use of the photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership.

membership
  Go PRIME   🛈 $ 240 SELECT
  Personal Plan 🛈 $ 3000 SELECT
  Business Plan 🛈 $ 9000 SELECT


  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance