Course "SOP Writing, Training and Compliance in the Pharmaceutical Industry" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Overview:
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 articulate 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 revise SOPs effectively and avoid unnecessary complications in procedures
To improve the writing of SOPs for more effective training and reduction of errors
To integrate the SOP effectively into the training curricula of employees
To identify different types of training curricula
To distinguish curricula from modules and individual training items
To structure curricula to facilitate qualifying employees to perform functions independently
To evaluate an employee's qualification to perform tasks using position curricula data
To take advantage of the connection between SOPs and job performance
To measure retention of SOP content at the training stage
To use data from training software to drive continuous improvement and stay ahead of deviations
Areas Covered in the Session:
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 Will Benefit:
Pharmaceutical industry, particularly those areas that develop SOPs for the manufacturing or quality monitoring of pharmaceutical products (Product Development, Production Planning, Manufacturing, Quality Assurance), as well as Information Technology (IT)
Pharmaceutical companies such as Pfizer, Johnson & Johnson and its associated companies (e.g. Janssen, DePuy-Synthes, Ethicon, Vistakon), Abbott, Merck, Bristol-Myers Squibb, Lilly, Novartis, Novo Nordisk, Amgen, Sanofi, AstraZeneca, Glaxo Smith Kline, Mylan, Almac, Hisamitsu, Cardinal Health, Baxter, Roche, Bayer, Boehringer Ingelheim, Takeda, Teva, Amgen, Biogen, AbbVie, Astellas, Daiichi-Sankyo
Parenteral Drug Association (PDA), GMP Training Educators' Association (GMP TEA), Institute of Packaging Professionals (IoPP), Association for Talent Development (ATD), Association for GMP Excellence (AGXPE)
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.
Agenda:
Day 1 Schedule
Registration Process - (8:30am - 9:00am)
Session will begin by - (9:00am)
8:30-8:59 Registration, Meet & Greet.
9:00 - 10:00
Lecture 1:
Seminar objectives review, expectations and scope.
Interview attendees re their specific responsibilities and needs
Agreement on focus
10:00 - 11:00
Lecture 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 - 12:00
Lecture 3:
Parameters of an effective SOP (scope, length, conciseness, responsibilities)
Distinguishing good SOPs from poor SOPs
Practice exercise
12:00 - 1:00 Lunch
1:00 - 2:00
Lecture 4:
Using process excellence tools to create a robust process and procedure
Brief process excellence exercise using areas of expertise in room
2:00 - 3:00
Lecture 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
3:00 - 4:00
Lecture 6:
Keeping training in mind while writing procedures
Simulation of a discussion between training and documentation
Attendee practice
4:00 - 4:30
Lecture 7:
Knowledge check for day
Day 2 Schedule
8:30-8:59 Registration, Meet & Greet.
9:00 - 10:00
Lecture 1:
Seminar objectives review, expectations and scope.
Review of Day 1 topics, feedback and conclusions
10:00 - 11:00
Lecture 2:
Relationship between SOPs and training curricula
Basics of training curricula
Structuring courses and modules
Demo of creating a curriculum with existing SOPs
11:00 - 12:00
Lecture 3:
Exercise in creating training curricula with existing SOPs - breakout groups and flip charts
Group review
12:00 - 1:00 Lunch
1:00 - 2:00
Lecture 4:
Curriculum completion and qualification to perform tasks
Special circumstances of systems training roles and curricula
Demo and practice of evaluating qualification
2:00 - 3:00
Lecture 5:
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
3:00 - 4:00
Lecture 6:
Course review
Questions and feedback
4:00 - 4:30
Lecture 7:
Knowledge assessment
Speaker
Michael Esposito
Principal, TrainReach Consulting, LLC & Life Science Training Institute
Michael Esposito has over 30 years experience in the pharmaceutical industry and 17 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 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, and sustainable packaging.
Location: Washington, DC Date: October 22nd & 23rd, 2018 and Time: 8:30 AM to 4:30 PM
Venue: Courtyard Arlington Crystal City/Reagan National Airport 2899 Jefferson Davis Hwy, Arlington, VA 22202, USA
Price:
Price: $1,295.00 (Seminar Fee for One Delegate) Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)* Register now and save $200. (Early Bird)
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