cGMP Procedure (SOP) Writing Course

Updated October 28, 2022

The mentioned course is no longer available.

The list of online courses offered by SkillsPlus International Inc. has been expanded. 

Learn more >>  CGMP Online Training Courses by SkillsPlus International Inc.

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483 Observation Gotchas!

 

1. Firm's procedures lack sufficient detail.

2. Employees perform significant steps not included in procedures.

3. Firm lacks procedures for a variety of production, maintenance, and quality assurance activities.

Planning for Training 2014!

 2014 is just around the corner! 

• Does your company constantly update and revise procedures, or
• Are procedures the root cause of many deviations, or
• Are procedures ignored, being replaced by word-of-mouth guidance from colleagues?

If you answered "Yes" to one or more of these questions, then you need to take a look at our Writing Standard Operating Procedures workshop.

Featured Course

Writing Procedures: This course is as much about consulting as training. In this course, Allan reviews and consults on a firm's procedure for writing procedures, and then coaches employees on procedure writing. Employees work with existing or needed procedures in this workshop.

Tools addressed in this very popular workshop:
1. Readability analysis

2. Task analysis

3. Decision-making through procedures

4. Determining the appropriate level of detail

5. Task grouping for greater comprehension

6. Procedure reviews and more!

 

If your firm is not satisfied with the quality of procedures, then you need to look into our Writing Procedures workshop!

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Ideas For 2014 GMP Training - Deviation Investigation Report Writing Clinic

483 Observation Gotchas!

 

1. Deviation reports failed to include a discussion of product impact.

2. Investigation reports stated this was an isolated incident, yet the database revealed 13 similar incidents.

3. Investigation reports failed to provide data to support the root cause determination

 

Planning for Training 2014!  2014 is just around the corner!  Do your investigation reports wander all over and never get to the point, or Do deviation reports fail to document a sound root cause conclusion, or Do deviation report writers never seem to know what Quality Assurance wants discussed in the report? If you answered "Yes" to one or more of these questions, then take a look at our Investigations Report Writing clinic.

 

Featured Course Deviation Investigation Report Writing Clinic: This course is hands-on and personal. In this clinic, students: learn about each section of your company's investigation report; write each section of the report for a real investigation report, and then; receive personal coaching privately from Allan. This course is not the typical spelling and grammar checking training program often offered.   Common sections addressed in this very popular workshop: 1. Deviation Description 2. Previous Related Investigations 3. Product Impact Assessment 4. Root Cause Investigation Discussion 5. Root Cause Determination 6. Risk Assessment 7. Corrective and Preventive Actions and more!   If your firm is not satisfied with the quality of deviation investigation reports, then you need to look into our Deviation Investigation Report Writing Clinic!   Examine The SkillsPlus Investigation Report Writing Clinic Outline

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SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

2014 GMP Training Recommendation - Root Cause for Deviation Investigations Workshop

Do your firm's   Planning for Training 2014!  2014 is just around the corner!  Do your firm's investigations conclude no assignable root cause, or Do your firm's investigations conclude the root cause was human error, or Do your investigations fail to identify product impact? If you answered "Yes" to one or more of these questions, then take a look at our Root Cause for Deviation Investigations workshop.

 

Featured Course Root Cause Analysis of Deviations: This course is more than idle chat. In this workshop, students apply root cause analysis tools to real in-plant deviations.   Tools addressed in this very popular workshop: 1. 5-Whys In-depth Map 2. Sequence of Events 3. Distinctions 4. Walk Through Analysis 5. Change Analysis 6. Control Barrier Analysis 7. Fishbone Diagrams and more!   If your firm is not satisfied with the quality of deviation investigations, then you need to look into our Root Cause Analysis of Deviations workshop!   Examine The Root Cause Analysis - Investigation of Deviations Outline      Allan Dewes, President.   About Your Instructor Allan Dewes Allan Dewes has worked on deviation investigations and trained others to do the same for over 30 years. Allan understands CGMP regulations, the FDA expectations, and how to make deviation training effective and fun.   Email today to request a quotation

 

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SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

Stop Blaming The Same Old "False" Root Causes

Updated May 19, 2022

Now offered as an online training program!

View advanced cGMP training courses taught by SkillsPlus International Inc.

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Pinpointing the wrong cause (for example, a "false" root cause) can result in ineffective immediate, corrective, and preventive actions.

• Throwing fixes at the wrong things might not fix the problem.
• Blaming and overusing human error as the root cause can result in incomplete and ineffective root cause analysis.

By taking our courses, you'll more confidently identify the real root causes, and craft clearer and more concise investigation reports.

.

These highly popular cGMP & QSR training classes are taught at the location of your choice, as a client on-site in-house training. You might be interested in two of our highly inter-related courses.

1. Root Cause Analysis for Better Investigations, and
2. Deviation Investigation Reports

- - - FIRST - - -

Root Cause Analysis for Better Deviation Investigations: On-site Training by SkillsPlus International Inc.:

"Purpose:

• To conduct or facilitate an individual or team-based investigation that solves problems and gets results, and complies with FDA expectations in the pharmaceutical and biotech industries. 

Objectives
1. Use tools and techniques to effectively identify the deviation statement.
2. Identify the root cause of the deviation.
3. Generate and objectively select the best corrective and preventive actions.
4. Assess the risk of implementing the corrective action and preventive action.
5. Develop a contingency plan to preventive action implementation.
6. Create corrective actions and preventive action metrics. 

About the Class
1. This class uses current deviations to practice the techniques taught.
2. The optional final exam is approximately 25 questions.
3. Each student receives a student guide containing a representation of the program's
slides and graphics with space provided for note taking.
4. This class can accommodate up to 25 people.
5. Duration: 8 hours."

'via Blog this'

- - - SECOND - - -

Deviation Investigation Reports: On-Site Training by SkillsPlus International Inc.:

Purpose:

• To use the data collected in an investigation to write a report and answer management and FDA questions.

 Objectives 

1. Increase investigation report suitability for FDA review. 
2. Decrease the number of reports returned by internal reviewers. 
3. Write supported deviation statements. 
4. Provide a detailed background statement to include related information, investigations, affected materials and references. 
5. Document deviation investigation findings. 
6. State the root cause with supporting facts. 
7. Generate supported, plausible, and defensible corrective actions. 
8. Develop effectiveness measures for the corrective actions. 
9. Generate realistic preventive actions. 
10. Develop effectiveness measures for the preventive actions. 
11. Develop a follow up plan for corrective and preventive actions. 
12. Write accurate executive summary statements. 

 About the Class

1. In-house deviation reports will be used to demonstrate and practice the skills and principles of this class.
2. This course is best taught in a computer lab. We can ship computer labs to your site if needed.
3. This course is customized to reflect your company procedure on writing deviation investigation reports. As we review that document we will make any recommendations to for change that we feel would be helpful.
4. The optional final exam is approximately 25 questions.
5. Each student receives a student guide containing a representation of the program's  slides and graphics with space provided for note taking.
6. This class can accommodate up to 12 people.
7. Duration: 8 hours as a minimum.

For more information:

• Root Cause Analysis for Better Deviation Investigations: On-site Training by SkillsPlus International Inc.
• Deviation Investigation Reports: On-Site Training by SkillsPlus International Inc.

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Onsite QSR & GMP Training - Procedure Writing for Greater Process Control

Updated October 11, 2025

This course is currently offered as an online e-learning course:

Writing SOPs:

https://skillsplusinc.com/sopclass.htm

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Procedure Writing for Greater Process Control - an on-site QSR & cGMP training class by SkillsPlus International Inc.

This instructor led course is taught onsite, in-house, at client plant locations. This class teaches how to develop more useful procedures that truly guide performance.

By the end of class, participants will be able to:
1. State the role of procedures.
2. Conduct a task analysis and knowledge assessment.
3. Determine appropriate procedure content.
4. Evaluate consistency and functionality of procedure format.
5. Write SOP statements and instructions.
6. Identify the procedures intended target audience.
7. State the regulatory guidelines for writing procedures.
8. Describe the procedure change control process.
9. Use procedures for training.

For more information, visit:
Procedure Writing for Greater Process Control - an on-site QSR & cGMP training class by SkillsPlus International Inc.

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CA HMDR Facilities Must Have Policies and Procedures

• California HMDR Exemptee Training Certification Course (accepted by the California Department of Public Health - Food and Drug Branch) - Buy Now!

Updated July 6, 2021

Pricing – Standard Operating Procedures Course

• $100 per student when co-purchased with our California Exemptee training course.
• Select our Writing Standard Operating Procedures (SOP) Couse as an optional “add-on” course when you purchase our California HMDR Exemptee license training certification course. In other words, buy this course, then add the optional SOP course during registration.

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Policies & Procedures Required For CA HMDR Facilities

The CA Home Medical Device Retailer (HMDR) licensing program is governed by law sections found in the California Sherman Food, Drug and Cosmetic Law. The Sherman Law was amended in the 1999-2000 legislative session to establish the HMDR licensing program. The applicable sections can be found in an abstract of the Sherman Law.

Section 111656.3 starts out with:

"Each home medical device retail facility shall have written policies and procedures related to home medical device handling and, if authorized by the department pursuant to Section 111656.4, the dispensing of prescription devices. Those written policies and procedures shall be adequate to assure compliance with this article and shall include, but not be limited to . . . "

Notice the phrase, " . . . shall have written policies and procedures . . . "

Not quite sure how to begin, and start writing them?

Then you might be interested in:
Buy Now: Writing Procedures: Drug and Device Wholesalers and HMDR 
 - an online training course from SkillsPlus International Inc.

Learn to write procedures quickly and thoroughly. Allan shares his experiences and techniques for writing procedures. This class is based on 30 years of experience writing procedures and teaching others to write them. This class is only for drug and device wholesalers, DME's and home medical device retailers. Pharmacists and pharmacy technicians responsible for procedures in their firm may also benefit. 

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Training program for California Home Medical Device Retailer (HMDR) Exemptee license applicants

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