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 how the writing of a procedure can have a positive or negative impact on training or employee performance, and as a result, training often misses the mark or employees make mistakes that could have been avoided with better synchronization between the activities of the documentation and training groups.
WHY SHOULD YOU ATTEND?
This session is designed to assist learners with the following 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
- To make better use of existing tools to evaluate the effectiveness of both SOPs and training
AREA COVERED
In this course, you will learn the vital connection between documentation and training, and how to maximize this connection to improve the quality of both SOPs and training, as well as job performance. This course is geared toward the pharmaceutical industry, particularly those areas which develop SOPs for the manufacturing or quality monitoring of pharmaceutical products, as well as Information Technology (IT).
The content will be especially beneficial for anyone who is an owner of a process, is responsible for writing or reviewing procedures, and/or manages training in a GMP environment. The course aims to provide practical information, which has already been used on the job effectively, and suggests similar actions that learners can apply to their job situations quickly.
LEARNING OBJECTIVES
- Regulatory requirements for SOPs
- Define the parameters of an effective SOP – How your foundation keeps subsequent steps from going awry
- Interact with the SOP process owner/author to improve the writing of procedures
- Translate the SOP into effective curriculum development and training execution
- Perform an ongoing assessment of the knowledge retention of learners for continuous improvement
- Review of learning objectives
WHO WILL BENEFIT?
- Documentation specialist
- Documentation manager
- Technical writer
- Trainer
- Training manager
- Quality Assurance specialist
- Quality Assurance manager
This session is designed to assist learners with the following 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
- To make better use of existing tools to evaluate the effectiveness of both SOPs and training
In this course, you will learn the vital connection between documentation and training, and how to maximize this connection to improve the quality of both SOPs and training, as well as job performance. This course is geared toward the pharmaceutical industry, particularly those areas which develop SOPs for the manufacturing or quality monitoring of pharmaceutical products, as well as Information Technology (IT).
The content will be especially beneficial for anyone who is an owner of a process, is responsible for writing or reviewing procedures, and/or manages training in a GMP environment. The course aims to provide practical information, which has already been used on the job effectively, and suggests similar actions that learners can apply to their job situations quickly.
- Regulatory requirements for SOPs
- Define the parameters of an effective SOP – How your foundation keeps subsequent steps from going awry
- Interact with the SOP process owner/author to improve the writing of procedures
- Translate the SOP into effective curriculum development and training execution
- Perform an ongoing assessment of the knowledge retention of learners for continuous improvement
- Review of learning objectives
- Documentation specialist
- Documentation manager
- Technical writer
- Trainer
- Training manager
- Quality Assurance specialist
- Quality Assurance manager
Speaker Profile
Michael Esposito
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 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 Johnson & Johnson Consumer Healthcare and revised their introductory GMP course. He is a member of the training organizations GMP Training Educators Association and Association for GXP Excellence and …
Upcoming Webinars
Microsoft Excel - Data Validation Techniques
Using Claude in Excel for Productivity, Automation & Data A…
2026 Form I-9 Changes & New ICE Penalties: What Every Emplo…
AI for Excel Professionals: Enhancing Productivity with Cha…
Leadership: Strategic Planning and Decision Making
Human Factors Usability Studies Following ISO 62366 and FDA…
Implementing an Effective Succession Plan to Identify, Deve…
FDA Compliance for Regulated Systems using COTS, Cloud, and…
Boost Financial Analysis with Claude in Excel
ChatGPT for HR - Build HR Policy Framework and Strategy
Unlock Employee Loyalty: Stay Interviews Will Keep Them Eng…
The Anti-Kickback Statute: Enforcement and Recent Updates
Emotional Intelligence: Mastering the Emotions of Great Lea…
Wage & Hour Laws: Ensuring Compliance with the Fair Labor S…
I-9 Enforcement & Compliance: A 5-Step Plan for Employers t…
Expense Reimbursements 2026 - Proper Recordkeeping and Acco…
Dealing With Difficult People: At Work & In Life
Claude AI For CPAs & Finance Professionals: Best Practices …
Construction Lending And Real Credit Administration: Evalua…
Mastering the Prompt: How Every Professional Can Use AI to …
Secrets Of The Staffing Fix - Solving The Employee Training…
Setting SMART Goals & Leveraging Storytelling for Reporting
Eliminate Harmful And Unproductive Drama In The Workplace
Using Copilot to Format Legal Documents in Microsoft Word
Discover how Emotional Intelligence turns AI from a technic…
Excel Spreadsheets; Develop and Validate for 21 CFR Part 11…
Major cGMP Issues: FDA Concerns in 2026
Elevate Your Workplace Wellness: 10 Critical Wellness Facto…
Maximizing Productivity with ChatGPT: AI Solutions for HR, …
2-Hour Virtual Seminar on In-Person Onboarding Your New Hir…
HR Auditing - New Update on Important Issues for 2026
Managers/Supervisors: New Role, Same Team - How to Lead Wit…