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 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

Interactive dashboards & analytics in Excel

Copilot and HR: An Introduction for HR Professionals

4-Hour Virtual Seminar on Bootcamp on Excel

Leading Across Generations: 5 Challenges & 10 Strategies to…


I-9 Audits: Strengthening Your Immigration Compliance Strat…

Fair Lending in 2025: New Regulations, Examinations and Enf…


Tattoos, hijabs, piercings, and pink hair: The challenges …

Using Emotional Intelligence to Elevate Your Leadership

ChatGPT & HR: How HR Recruiting Professionals Can Leverage …

FDA Trends in Compliance and Enforcement in Computer System…

Elevate Your Workplace Wellness: 10 Critical Wellness Facto…

How to Manage the Legal Landmine of the FMLA, ADA and Worke…

How to Write a Successful Job Hazard Analysis


How to Write Right for Better Business Communication

How to Prepare For and Host a FDA Inspection and Respond to…

Public Speaking: Overcoming The Fear of Public Speaking

From Good to Great: The Secrets to an Optimized LinkedIn Pr…



Workplace Investigations 101: How to Conduct your Investiga…

Policy Pops: Navigating DEI in the 2025 Workplace: Strategi…

The Five Cs Of Commercial Credit: The Basic Elements Of Cre…

Transforming Anger And Conflict Into Collaborative Problem …


Navigating Alcohol and Drug Addiction Protections Under the…


Reduce Stress in the Workplace: Effective Ways to Handle Co…



Transforming HR with AI: Unlocking Excellence and Innovation

Creating Employee Handbooks that Protect You and Support th…

FDA Technology Modernization Action Plan (TMAP) and Impact …


Transform Data into Insights: A Beginners Guide to Excel Pi…


Mindful Communication:The Key to Meaningful Conversations i…

FDA Proposes Framework to Advance Credibility of AI Models

50+ new Excel features so far this decade

FMLA Compliance in 2025: A Comprehensive Guide & Strategies…

Excel - 10 Key Worksheet Functions to Skyrocket Your Produc…

Managing Toxic Employees: Strategies For Leaders To Effecti…

Hiring and Retaining Employees in this Crazy Economy

Harassment, Bullying, Gossip, Confrontational and Disruptiv…