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
Surviving and Thriving Organizational Change and Loss: The …
Impact Assessment and Risk Management for Change Control
Excel Deep Dive: Advanced Tips & Techniques – A 3-hour Work…
How to Write Effective Audit Observations: The Principles f…
Coming Soon - New Minimum Salary Levels for Exempt Employee…
Marijuana: Compliance and Safety in the Workplace
FDA Regulation of Artificial Intelligence/ Machine Learning
Stressed Out: How to Handle Conflict, Difficult People and …
2025 Top Employment Regulations That Will Impact Employers!
How to Handle Workplace Conversations Around Politics and R…
Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud,…
How to Give Corrective Feedback: The CARE Model - Eliminati…
Improving Employee Engagement & Retention Through Stay Inte…
SOPs - How to Write Them to Satisfy those Inspectors
Why EBITDA Doesn't Spell Cash Flow and What Does
With Mandatory Paid Leave Gaining Ground Is It Time To Do A…
Marketing to Medicare or Medicaid Beneficiaries - What You …
Human Error Reduction Techniques for Floor Supervisors
Documenting Misconduct that Will Stand Up in Court
Trial Master File (TMF)/eTMF, & FDAs Draft Guidance for Ele…
Tattoos, hijabs, piercings, and pink hair: The challenges …
Project Management for Non-Project Managers - How to commun…
OSHA Requirements for Supervisors, Project Leaders & HR - W…
Humane Layoffs: How to Let People Go with Compassion and De…
Unlock Employee Loyalty: Stay Interviews Will Keep Them Eng…
Sunshine Act Reporting - Clarification for Clinical Research
FFIEC BSA/AML Examination Manual: What Compliance Officers …
Female to Female Hostility @Workplace: All you Need to Know
Onboarding is NOT Orientation - How to Improve the New Empl…
FDA Technology Modernization Action Plan (TMAP) and Impact …
Excel - Pivot Tables - The Key To Modern Data Analysis and …
Managing Toxic & Other Employees Who Have Attitude Issues
Building GMP Excellence: A Guide to Implementing Compliant …
Excel Power Skills: Master Functions, Formulas, and Macros …