SOP Writing, Training and Compliance in the Pharmaceutical Industry
View: 108
Website https://www.complianceonline.com/sop-writing-in-pharma-gmp-environment-seminar-training-80560SEM-prd |
Edit Freely
Category Pharmaceutical, Drug, Laboratory
Deadline: February 26, 2025 | Date: February 26, 2025-February 27, 2025
Venue/Country: Washington, DC, U.S.A
Updated: 2024-10-25 16:01:07 (GMT+9)
Call For Papers - CFP
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 SOPTo learn the parameters of an effective SOPTo distinguish a well-written SOP from a poorly written oneTo define processes better by effective interaction with the SOP process owner and/or authorTo integrate the SOP effectively into the position curricula of employeesTo explore the connection between SOPs and job performance, and measure retention of SOP content at the training stageAreas Covered :Regulatory requirements for SOPsUsing process excellence tools to create a robust process and procedureWhat commitments you make when you put your process in writingKeeping training in mind while writing proceduresConsequences of noncomplianceDefine the parameters of an effective SOPHow your foundation keeps subsequent steps from going awryWhy poorly written procedures have a negative impact on productionWhat identifies a poorly written procedureCompliance risks with ambiguity or excessive detailInteract with the SOP process owner/author to improve the writing of proceduresIntegrate the SOP effectively into the position curricula of employeesRelationship between SOPs and employees’ training curriculaWhy the training department needs to be in the loop at the start of the SOP development processRetention of the content at the training stageThe implications of good training for successful SOP executionPerform an ongoing assessment of knowledge retention of SOPs for continuous improvementReview of learning objectivesWho 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)
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.