DUBLIN–(BUSINESS WIRE)–The “SOP Writing, Training and Compliance in the Pharmaceutical Industry” training has been added to ResearchAndMarkets.com’s offering.
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
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
Key Topics Covered:
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 (9:00 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
For more information about this training visit https://www.researchandmarkets.com/r/y0sm44.