FDA complicates 'chaotic' federal COVID-19 response with pledge to resume domestic inspections - Fierce Pharma

• FDA cGMP QSR GMP Online Training Courses - presented by SkillsPlus International Inc.

Read the full source article:

FDA complicates 'chaotic' federal COVID-19 response with pledge to resume domestic inspections - Fierce Pharma

According to the article:

"The FDA will resume "prioritized" domestic manufacturing inspections the week of July 20 after a four-month moratorium on most on-site walkthroughs, FDA Commissioner Stephen Hahn, M.D., said in a release Friday. 

However, a troubling uptick in new COVID-19 cases and deaths means the agency will weigh local virus activity when deciding which sites to inspect, and that fact had analysts questioning the FDA's announcement."

Read the FDA Statement, Coronavirus (COVID-19) Update: FDA prepares for resumption of domestic inspections with new risk assessment system - FDA.gov

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-------------------

SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Free GMP Training Tips
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

GMP Training Tips For Modern Learners

cGMP Training - Free Tips For Training Modern Learners

GMP trainers need to be ready for the students of today.

Here are a few training strategy tips for teaching "modern learners."

• They've got so much to do, they're pulled in many directions, and they can't pay attention to you - TIP:  Craft topics & course titles that are truly useful and valuable to these students. Design courses that are shorter, concise, and to the point. 
• They're glued to their devices, constantly pinged & pinging - TIP: Grab and keep their attention through interaction and activities.
• They absorb information quickly - TIP: Try to share information visually and graphically for better recall.

Need more help? Then call Allan Dewes (principal trainer at SkillsPlus Intl Inc.) because of his:

1. established track record (working with myriad pharma-biotech clients)
2. subject matter expertise (cGMPs, QSR, and more)
3. mastery of the classroom and students

#FDA #cGMP #QSR #GMP #training #courses #classes #live #onsite

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SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around

WHO Training Guide To GMPs - FREE

• People also search for Current Good Manufacturing Practice Training: A New Generation Series - CGMP Online Courses - GMP online training classes offered by SkillsPlus International Inc.

This is a wonderful free resource for those involved in or responsible for delivering GMP training or classroom sessions. The World Health Organization (WHO) published this guide, so that it could "help both trainers and supervisors solve some of the problems they face involving training, such as how to make the training interesting to adult learners or how to effectively use a variety of instructional methods."

A WHO Guide To Good Manufacturing Practice (GMP) Requirements, Part 3: Training (PDF), is organized by the following major chapters:

1. Introduction and purpose of this guide
2. The importance of training
3. Types of training and content areas
4. Developing and implementing training
5. Assessment and evaluation
6. Administrating a training programme
7. Questionnaire

#FDA #cGMP #GMP #training #WHO

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

Choose Live On-Site Instructor-Led GMP Training - - Benefits

Updated March 10, 2021

Given the COVID-19 pandemic, people also search for CGMP online training such as:

Current Good Manufacturing Practice Training: A New Generation Series - CGMP Online Courses

- - -  the original post follows below  - - -

On-site training, taught live by an instructor, is the perfect choice for companies that need to train groups of employees.

The Benefits of Live On-Site Instructor-Led cGMP Training:

You'll . . .

1. Get a maximum number of employees trained in new skills in a minimal amount of time on the date, and location of your choice. 
2. Be able to deliver the same customized message & course content at the same time, ensuring everybody gets on the same page. 
3. Ensure knowledge & skills transfer from classroom to workplace.
4. Get an expert trainer's insights and hear real-world examples.
5. Experience face-to-face interaction with real-time feedback.
6. Get a more comfortable training environment that supports the learning of complex material.

Taking advantage of onsite instructor-led training classes gives you the optimal balance of facilitation, group exercises, case studies, and practical application exercises. Learn more, call: (415) 948-5220.


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Root Cause Analysis for Better Deviation Investigations - Onsite Courses - Popular

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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SkillsPlus Intl Inc. - GMP & QSR Compliance Training Experts website

In-Plant On-Site GMP Training & QSR Training Courses

Updated March 10, 2021

Given the COVID-19 pandemic, people are also searching for CGMP online training courses:

Current Good Manufacturing Practice Training: A New Generation Series - CGMP Online Courses

- - -

We offer onsite, in-plant GMP training & QSR training courses.

If you've got training needs, we've got the courses and classes for you!

1. Our live classes span QSR and cGMPs, and more! 
2. We're training experts with experience! 
3. Avoid boring courses. Students love our exciting, energizing, and engaging classes! 

Learn more about our training offerings that can be delivered at the location of your choice:
Live, in-plant, on-site, GMP training & QSR training courses taught by SkillsPlus Intl Inc.

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Qualstar Simulation - Advanced QSR & GMP Training Onsite

Qualstar Simulation: CGMP or QSR Advanced Onsite Training Course by SkillsPlus Intl Inc

This highly interactive on-site training class is action packed and keeps students energized. Students actually have fun while learning!

This is an instructor led course taught onsite, in-house, at client locations.  Students learn about the importance of documentation, procedures, change control and QA.

By the end of class, participants will be able to:

1. demonstrate proper documentation practices. 
2. experience the value of well-written procedures. 
3. demonstrate proper actions when procedures contain errors. 
4. experience the value of the quality unit.

Get your employees excited about learning and training with this exciting and engaging class!

Learn more about this live training class:

Qualstar Simulation: CGMP or QSR Advanced Onsite Training Course by SkillsPlus Intl 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

---  the original post follows below  ---

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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• 2012 Onsite cGMP & QSR Compliance Courses by SkillsPlus Intl Inc. (skillsplusinfo.blogspot.com)

Olympics for Medical Device Manufacturers - Onsite QSR Training Class

This class gets students engaged, energized, and so excited that they'll be up out of their seats!

Olympics for Medical Device Manufacturers - Onsite QSR Training by SkillsPlus International Inc.

This course takes QSRs to a deeper level of understanding through a series of challenging activities. Past students would say this training is fun!  This instructor led class is taught on-site in-house at client plant locations.

By the end of class, students will be able to:
1. List the hottest issues in QSR compliance.
2. Locate items of interest in 21CFR820.
3. Explain the 21CFR211 rationale for specific 483 observations.
4. Demonstrate knowledge of common CGMP practices and details.
5. State the consequences of not following QSR.

For more information, visit:
Olympics for Medical Device Manufacturers - Onsite QSR Training by SkillsPlus International Inc.

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Onsite cGMP Training - Olympics for Pharmaceutical & Biotech Manufacturers

Updated June 5, 2021

Given the COVID-19 pandemic, people are also interested in:

FDA GMP Online Training - respected FDA CGMP online training courses presented by SkillsPlus International Inc.

---  original post follows below  ---

Onsite cGMP Training -  Olympics for Pharmaceutical & Biotech Manufacturers - by SkillsPlus International Inc.

How many boring training classes have you and your colleagues been through?!

Say NO to boring training. Experience exciting, energizing, and engaging training!

Take a deep dive to a deeper level of understanding through a series of challenging activities.

By the end of this class, energized students will be able to:
1. List the hottest issues in CGMP compliance.
2. Locate items of interest in 21CFR211.
3. Explain the 21CFR211 rationale for specific 483 observations.
4. Demonstrate knowledge of common CGMP practices and details.
5. State the consequences of not following CGMPs.

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SkillsPlus Intl Inc. - GMP & QSR Compliance Training Experts website

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ISO 17025: Calibration Laboratories - Onsite Training Class

If you need to understand the expectations of a metrology lab from the global perspective, and not just from the US perspective, then you need this course:

 ISO 17025: Calibration Laboratories - live on-site training by SkillsPlus International Inc.

In this class, you'll learn the details of ISO 17025 as it relates to calibration laboratories. This class is instructor-led, and taught on-site in-plant, at client locations.

Upon class completion, students will be able to:

1. Explain the rationale for ISO 17025. 
2. Explain the management requirements from a regulatory perspective. 
3. Explain the technical requirements from a regulatory perspective.

For more information, and to view a list of the topics covered, visit:

 ISO 17025: Calibration Laboratories - live on-site training by SkillsPlus International Inc.

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Human Errors: Overcoming the Challenges - Onsite cGMP & QSR training

Human Errors: Overcoming the Challenges - live on-site cGMP & QSR training by SkillsPlus International Inc.

Humans make errors, AND, more likely, there are processes and systems that are root causes of setting people up to fail.

Purpose:
This class teaches how to overcome human errors as a root cause to deviations.

Objectives:  upon class completion, students will be able to . . .
1. State what the CGMPs imply regarding human errors.
2. State the FDA's current thinking about human errors and deviations.
3. Describe the basics of root cause determination.
4. List the possible root causes to human errors.

Topics Covered:

• Overview of 483 observations
• Psychology of human failures
• Investigating human errors
• Preventing human errors

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Executive Session: What Leadership Needs to Know - cGMP training

Updated February 18, 2025

The Executive Session course is no longer available.

You might also be interested in:

The best and recommended choice for FDA GMP QSR cGMP Online Training: 

FDA cGMP QSR GMP Online Training - popular online training courses by SkillsPlus Intl Inc. 

#FDA #cGMP #GMP #QSR #training | Recommended | Respected | Popular | The best choice for FDA CGMP online training courses and programs.

---  the original post follows below  ---

Executive Session: What Leadership Needs to Know - live onsite cGMP & QSR training by SkillsPlus International Inc.

Executives and top leadership teams need to be knowledgeable, in order to lead the troops!

Purpose:
Addresses CGMP and QSR issues directly relevant to the executive leadership and executive teams of manufacturers.

Objectives:   upon class completion, leaders will be able to . . .
1. State the common 483 observations issued by the FDA.
2. List the basic requirements of CGMP or QSRs that require the attention of the leadership team.
3. Identify gaps in compliance.
4. Identify the issues that needs to be rectified.

For more information, visit:
Executive Session: What Leadership Needs to Know - live onsite cGMP & QSR training by SkillsPlus International Inc.

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Essentials for Pharmaceutical Manufacturers - Live onsite cGMP training

Updated July 16, 2021

Links in the original post broke.

You might also be interested in:

CGMP Training: A New Generation - Course Descriptions

---   the original post follows below   ---

Essentials for Pharmaceutical Manufacturers is a SkillsPlus International Inc. course - it's a live onsite cGMP training class taught on-site, in-house, at client plant locations.

It's the perfect introductory class for employees new to the pharma-biotech industry, and also serves as a wonderful refresher course for staff needing continuing education.

By the end of this engaging interactive class, students will be able to:
1. State the historical development of CGMP regulations.
2. Explain the role and function of standard operating procedures.
3. Describe the personal role for contamination control.
4. Identify the sources of contamination.
. . . and much more!

For more information, go to:
Essentials for Pharmaceutical Manufacturers is a SkillsPlus International Inc. course

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Essentials for Medical Device Manufacturers - QSR training class

Updated June 5, 2025

This specific course is no longer offered.

You might also be interested in these online training programs:

https://skillsplusinc.com/cbpresent.htm

---  the original post follows below  ---

In this original or refresher training, experience fun learning the regulations.

Essentials for Medical Device Manufacturers by SkillsPlus International Inc. is an instructor-led training class, taught on-site in-house at client plant locations.  This is useful as a new employee basics course, and can be used as a refresher course.

Purpose:
This class teaches employees how to identify the essential elements of QSR for beginning work in the medical device industry.

Objectives:
Upon class completion, students will be able to . . .
1. State the historical development of QSR regulations.
2. Explain the role and function of standard operating procedures.
3. Describe the personal role for contamination control.
4. Identify the sources of contamination.
5. List the common QSR documentation practices.
6. Explain material controls.
7. State the common practices of production and process controls.
8. Explain the importance of an adequate, appropriate, and sufficient building design.
9. State the requirements of equipment design and construction.
10. List the requirements for building, and equipment cleaning and maintenance.
11. Explain the role of the quality management system.
12. Explain the role of the laboratory.

Topics:

• Heard on the street
• Past, present, and future
• Legal issues
• Personnel responsibilities
• Standard operating procedures
• Contamination
• Personal hygiene
• Cleaning
• Documentation
• Materials
• Process control
• Buildings and facilities
• Equipment
• Validation
• Calibration
• Laboratory
• Quality management system

For more information about this class:
Essentials for Medical Device Manufacturers by SkillsPlus International Inc

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Additional Keywords: biotech, cGMP, class, compliance, course, device,energizing, engaging, exciting, FDA, GMP, instructor, interactive, international, manufacturer, medical, QSR, seminar, SkillsPlus,trainer,training

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Deviation Investigation Reports - Live onsite cGMP & QSR training class

Deviation Investigation Reports is a live on-site cGMP & QSR training class taught by SkillsPlus International Inc.

This class is instructor-led, and is taught at client manufacturing plant locations.

Purpose:
This class teaches students how to use the data collected in an investigation to write a report and answer management and FDA questions. Students learn how to summarize the important points of the investigation that support the root causes.

Objectives:
Upon class completion, students will be able to:

1. Increase investigation report suitability for FDA review. 
2. Decrease the number 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. 

Class Topics:

• Incident description 
• Investigations and affected materials 
• Deviation investigations 
• Corrections (path forward) 
• Corrective actions 
• Preventive actions 
• Background information

For more information, visit:

Deviation Investigation Reports is a live on-site cGMP & QSR training class taught by SkillsPlus International Inc. 

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Additional Keywords: cGMP, GMP, QSR, live,onsite,on-site,in-plant,plant,instructor-led,training,class, course, FDA, deviation, investigation,reports, CAPA, SkillsPlus

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Root Cause Analysis for Better Investigations - Live onsite cGMP & QSR training class

Root Cause Analysis for Better Investigations - onsite cGMP & QSR training by SkillsPlus International Inc.

Learn how to conduct better investigations and address CAPA regulatory requirements.  This is an instructor-led live training class, taught on-site at client locations.

Purpose of this live class: 

• Teaches students how 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 for this onsite training: 
     Upon course completion, students will be able to . . .

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. 

Course topics include: 

• Deviation statement 
• Deviation investigation 
• Root cause analysis 
• Corrective actions 
• Preventive actions 
• Risk analysis 
• Metrics 

For more course information: 
Root Cause Analysis for Better Investigations - onsite cGMP & QSR training by SkillsPlus International Inc.

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Additional Keywords: biotech, cGMP, class, compliance, course, device, drug, FDA, GMP, instructor, interactive, International, manufacturer, medical, pharmaceutical, QSR, seminar, SkillsPlus, training

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Creating CGMP and QSR Responsibility and Accountability - Training Class

Updated July 1, 2025

The original link broke.

People also buy FDA CGMP Online Training - recommended FDA GMP online training courses offered by SkillsPlus International Inc.

---  original post follows below  ---

Live onsite GMP & QSR training class:
  Creating CGMP and QSR Responsibility and Accountability - training by SkillsPlus International Inc.

This is instructor-led, and taught on-site at client locations.

Giving feedback can be challenging, and doing so in a regulated industry makes it even more interesting. Don't get stymied, learn how to do it easily and effectively.

Purpose of this class:
To raise the standard of CGMP and QSR compliance throughout the organization, and to provide strong and positive coaching techniques.

Objectives:
Upon completion of this class, studenst will be able to:

1. Review the CGMP/QSR Regulations. 
2. Set climate for a compliance discussion. 
3. Create a compliance message. 
4. Provide behavioral feed back. 
5. Create responsibility for CGMPs and performance. 
6. Establish an atmosphere of accountability. 
7. Hold non-threatening discussions with employees as a part of a corrective action plan.

Topics include:

• Direct reports
• Communication skills for supervisors and leaders
• Motivation
• Goals
• Delegation
• The compliance message

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Additional Keywords: biotech, cGMP, class, compliance, device, drug, FDA, GMP, instructor, manufacturer, medical, pharmaceutical, QSR, SkillsPlus, training,

Faster Product Release Through Efficient Batch Record Review - Onsite cGMP & QSR Training Class

Updated March 17, 2023

The batch record review course is no longer available.

You might also be interested in FDA cGMP online training programs and courses offered by SkillsPlus International Inc.

---  the original post follows below  ---

Faster Product Release Through Efficient Batch Record Review - Live onsite cGMP & QSR training by SkillsPlus International Inc.

This is a live on-site class. It is instructor-led and taught at the client location of your choice.

Purpose:
This live on-site GMP & QSR training class teaches students how to competently review batch records to identify errors and issues.

Objectives:
Upon course completion, students will be able to:
 1. State the source of batch record requirements for both US and EU
 2. Distinguish between the production and QA batch record review
 3. List best practices in Batch Record Review
 4. Demonstrate at least 5 different batch record review activities.

Topics include:

1. Regulation review 
2. US & EU Requirements and Regulatory Expectations 
3. Best Practices 
4. BPR Regulations Background 
5. BPR Audit Items: Skills Practice 
6. Trending

For more information, visit:

Faster Product Release Through Efficient Batch Record Review - Live onsite cGMP & QSR training by SkillsPlus International Inc.

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Additional Keywords: biotech, cGMP, class, compliance, device, DME, drug, energizing, engaging, exciting, FDA, GMP, instructor, interactive, manufacturer, medical, ,pharmaceutical, QSR, SkillsPlus, trainer, training,

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Auditing: Internal and External Customers and Suppliers - Onsite GMP & QSR Class

Updated October 29, 2022

The "Auditing" course is no longer available.

You might also be interested in:

FDA cGMP online training courses, programs, and classes offered by SkillsPlus International Inc.

---  the original post follows below  ---

Auditing: Internal and External Customers and Suppliers - is a live on-site cGMP and QSR class by SkillsPlus International Inc.  This training is delivered as an in-house class taught at the client's location.

Purpose:
This class teaches students how to:

• apply an auditing model that applies to a wide-variety of situations
• qualify suppliers, to assure that they meet your specifications and appropriate GMPs

Objectives:
Upon class completion, students will be able to:

1. State the regulatory requirements for audits. 
2. Identify common reactions to the audit process. 
3. Manage adverse reactions to audits. 
4. Plan an efficient and thorough audit. 
5. Apply the Quality System inspection approach for audit planning. 
6. Review relevant regulations applicable to the audit area. 
7. Gather evidence of compliance/noncompliance. 
8. Report results to affect change and build relationships. 
9. Manage the corrective action and preventive action process

Topics covered in class include:

• Managing audits
• Pre-audit questionnaire
• Audit focus
• Gathering evidence
• Ratings
• Auditing report

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- - -

• 2012 Onsite cGMP & QSR Compliance Courses by SkillsPlus Intl Inc. (skillsplusinfo.blogspot.com)
• FDA Audit Preparation (drughealth.blogspot.com)
• Batch Record Review Training - a live cGMP class (skillsplusinfo.blogspot.com)