I Like GMPs - PharmaManufacturing.com

I Like GMPs: Even if regulators didn’t require GMPs, I would follow the practices - PharmaManufacturing.com:

"Yes, regulators have set clear expectations for those of us in pharmaceutical manufacturing about calibrating and validating equipment; maintaining clean facilities; training qualified employees; and demonstrating that our processes are reliable and reproducible, and that our validation methods have been tested and re-tested.

But even if those expectations weren’t regulated, GMP is simply good business practice. We need to know what we are doing, how we are doing it, be able to document it, and then figure out how to make it all better. This is what any good businessperson does to keep the enterprise running smoothly and in the most profitable way possible. So in response to my fair colleague, who would abandon GMP if possible, I must humbly disagree."

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ASTD Reboots With New Name (ATD) and Logo

ASTD Reboots With New Name and Logo | 2014-05-06 | ePublishing:

"The American Society for Training and Development is changing its name to the Association for Talent Development. The announcement came from ASTD president and CEO Tony Bingham in a Tuesday afternoon event at the 2014 ASTD International Conference and Exposition in Washington, D.C.

“Now is the time for ASTD to adapt and meet you where you are, to align to where the profession is and where it’s going,” Bingham said. “This is a journey of redefining our brand and widening a path to a future that is grounded in the work you do in developing the talent of today and tomorrow.”"

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What To Do 15 Minutes Before A Presentation - Business Insider

Click the link below to see the 10 things you can do . . .

What To Do 15 Minutes Before A Presentation - Business Insider:

"Whether you're stepping to the front of the room to speak to just a few people, or making a grand entrance in a ballroom to address thousands, you can effectively use the time immediately before you go up to prepare your body and mind for peak performance, Price says.

Here are 10 things you can do in the 15 minutes before a big presentation to optimize your speaking success:"

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FDA - Product Requirements, Marketing & Labeling > Extending Authorities to Additional Tobacco Products

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

Updated July 1, 2025

The original link broke.

You might also be interested in:

FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements

Guidance for Industry: 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-deems-certain-tobacco-products-subject-fda-authority-sales-and-distribution-restrictions-and

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Product Requirements, Marketing & Labeling > Extending Authorities to Additional Tobacco Products - FDA:

"Currently FDA regulates cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco. Proposed newly “deemed” products would include electronic cigarettes, cigars, pipe tobacco, certain dissolvables that are not “smokeless tobacco,” gels, and waterpipe tobacco.

Once the proposed rule becomes final, FDA will be able to use powerful regulatory tools, such as age restrictions and rigorous scientific review of new tobacco products and claims to  reduce tobacco-related disease and death."

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Regulatory Explainer: Why and How is FDA Regulating Mobile Apps? - Regulatory Focus

Regulatory Explainer: Why and How is FDA Regulating Mobile Apps? - Regulatory Focus:

"In Brief, What's This Issue About?

In the US, the Food and Drug Administration (FDA) regulates many products to ensure that they are safe and effective, including medical devices such as wheelchairs and pacemakers. However, the definition of "medical device" also includes software, and in recent years FDA has moved to regulate software found on mobile phones, what most people refer to as "mobile apps."

Critics have raised the point that strict regulation of medical mobile apps could stifle innovation in the sector, while others have pointed to spurious or faulty apps to make the point that regulation is sorely needed."

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Hamburg to PhRMA: If you don't have quality, the rest doesn't matter - FiercePharma

Hamburg to PhRMA: If you don't have quality, the rest doesn't matter - FiercePharma:

"she said, high-risk products like sterile injectables need to be produced with proper attention for sterile procedures. Advances in science and technology can make a difference, too: Pharma can use quality by design, continuous manufacturing and other approaches to help improve both quality and efficiency in the production process, rooting out preventable problems that create shortages and compromise patient trust.

"It's just so fundamentally important," she said. "If you don't have quality, all the rest of it really doesn't matter.""

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GMP Trainers - Ensure That They Are Qualified Individuals

Updated March 14, 2021

You might also be interested in our online version of the course:

GMP Trainer Awareness, Certification, & Master Trainer Course. This online self-study course leads participants through many different ways to teach cGMPs and QSRs. Learn how your class instructor thinks about delivering a training session to students, so you can repeat that training approach in your own organization.

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GMP trainers must be "qualified individuals," according to 21 CFR 211 Subpart B.

Do you want to make sure your GMP trainers are qualified?

If you said yes, then consider this highly recommended course:

CGMP/QSR Trainer Certification Program - May 5-9, 2014 - Public Seminar in Fort Lauderdale, FL

Reference:  21 CFR 211 Subpart B:

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER C--DRUGS: GENERAL

PART 211 -- CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS

Subpart B--Organization and Personnel

Sec. 211.25 Personnel qualifications.

(a) Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee's functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.

(b) Each person responsible for supervising the manufacture, processing, packing, or holding of a drug product shall have the education, training, and experience, or any combination thereof, to perform assigned functions in such a manner as to provide assurance that the drug product has the safety, identity, strength, quality, and purity that it purports or is represented to possess.

(c) There shall be an adequate number of qualified personnel to perform and supervise the manufacture, processing, packing, or holding of each drug product.

FDA Reduces GMP Inspections by 40 Percent, Focuses on Imports - PharmaManufacturing

• FDA GMP online training programs, courses, and classes by SkillsPlus International Inc.

FDA Reduces GMP Inspections by 40 Percent, Focuses on Imports - PharmaManufacturing:

"The FDA plans to conduct 591 domestic good manufacturing practice (GMP) inspections in fiscal 2014 and 2015, down from the 967 performed last year. The agency in turn hopes to perform 30 percent more foreign GMP inspections, conducting 843 inspections each year, up from last year’s 604. Companies will be chosen for inspection based on the agency’s risk-based inspection model that grants leeway to high-quality companies. The FDA takes into account risk factors including Class I recalls and adverse events, as well as compliance history, in applying the risk-based inspections model to its decision making."

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GMP Trainers - Why You Should Get Training

GMP Training Certification Course: GMP Trainer Awareness, Certification, and Master Trainer Course - Online Self-Study

• It's important to learn the most effective ways to train your employees
• Never stop learning! Train & be trained as often as possible
• Your training toolbox should have a ton of things in it. 

FDA GMP Trainer Certification Course

"The mediocre teacher tells. The good teacher explains. The superior teacher demonstrates. The great teacher inspires." - William Arthur Ward

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Become A Better GMP Trainer

Updated October 26, 2022

You might also be interested in this course offering.

GMP Trainer Awareness, Certification, and Master Trainer Courses

This online self-study course leads participants through many different ways to teach cGMPs and QSRs. Learn what a class instructor thinks while delivering a training session to students, so you can repeat that training approach in your own organization. 

Pricing | Questions? - Call us:  (415) 948-5220

How This Course Is Implemented

This course is implemented in three phases: Awareness, Certification, and Master Trainer. This is NOT a public seminar workshop. Our public seminar was so popular; we turned it into an online self-study course that fits into your busy schedule.

• GMP Trainer Awareness – Students view presentations covering the course objectives below.
• GMP Trainer Certification – Students view the “Awareness” presentations. Students then prepare elements of a training session demonstrating the application of the content taught in the awareness course, or in some cases, capture and submit video segments of an actual or practice training session. All information submitted will be reviewed and critiqued by a team of Master Trainers. This course is taken simultaneously with the Awareness course.
• GMP Master Trainer – Learn GMP content to assure you know the basic GMP rules. This phase of the program is under development.

In this course, you will learn how to:

• Apply a Participant Centered Approach to training
• Write course objectives
• Development a course assessment
• Describe the difference between ice breakers and activities
• Describe and develop ice breakers for a class
• Describe and develop activities for a class
• Explain the role of the instructor during activities
• Develop an activity debriefing strategy
• Describe various strategies for forming groups
• Design a course presentation
• Identify and demonstrate effective presentation skills
• Develop stories for a class and how to deliver the story
• Develop discussion questions
• Develop and implement discussion follow-up strategies
• Demonstrate the management of disruptive behavior
• Identify the elements of a course assessment validation plan
• Identify the elements of a course evaluation form
• Develop a course evaluation form

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Trainers must be skilled!

• They must be expert course designers and facilitators
• They must pay attention to the experiential learning process
• They must keep students involved, engaged, and energized

It’s a given that GMP & QSR trainers must have mastery over the regulations that they are teaching. Mastering applicable laws, regulations, directives, standards, guidance, and compendia for manufacturing biologics, drugs, dietary supplements, and medical devices is essential for raising your company’s employees and management team compliance competency.

GMP & QSR trainers must also be able to help others expand their knowledge of relevant regulatory requirements, and to help others apply that knowledge in the workplace.

What does that mean?

It means that trainers must have the skills needed to teach others. We often find that trainers, program designers, training supervisors, training managers, and others who conduct GMP or QSR training in the pharmaceutical, biotech, medical device or dietary supplement industries need help in developing their training skills.

Expert GMP & QSR trainers:

1. Focus on experiential learning processes
2. Teach in a facilitation and learning style that’s appropriate to particular regulatory topics
3. Design and facilitate learning activities
4. Facilitate meaningful discussions, and create safe environments through the debrief process
5. Model different teaching strategies
6. Tell compelling case stories
7. Keep students involved, engaged, and energized

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