DRUG FRAUD ALERT: DISTRIBUTOR/CUSTOMER PRODUCT ORDERING SCHEME

• Trusted Board-approved California Designated Representative online training programs for wholesaler, 3PL, and reverse distributor license applicants. Learn more & buy.

"Since December 2020, there have been reports of both distributors as well as several of their pharmacy customers receiving telephone calls and/or emails as part of a sophisticated “phishing” scam to unlawfully divert pharmaceutical goods in transit."

"RECOMMENDED ACTIONS TO PROTECT DISTRIBUTORS: RISK MITIGATION

There are several ways to validate correspondences with what appear to be legitimate distributor customers: ... "

Go to the following source document to view the complete list of recommended actions.

Source:   FRAUD ALERT: DISTRIBUTOR/CUSTOMER PRODUCT ORDERING SCHEME Version 2 (Updated June 2022) - HDAPCSC (PDF)

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For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training 
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Keeping the U.S. Prescription Drug Supply Chain Among the Safest in the World | FDA Voice

Read the full article: Keeping the U.S. Prescription Drug Supply Chain Among the Safest in the World | FDA Voice:

"I’m pleased to share an important new advancement to help protect the U.S. and global supply chain for prescription drugs and other medical products. Over the past four years, FDA led a team of international partners to create the Supply Chain Security Toolkit for Medical Products. "

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Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

FDA to Drug Compounders: Inspection Changes Coming in August | RAPS

• Recommended FDA cGMP online training courses, classes, and programs sold by SkillsPlus International Inc.

Updated October 8, 2022

You might also be interested in:

Human Drug Compounding - FDA.gov

---  the original post follows below  ---

Read the full article: FDA to Drug Compounders: Inspection Changes Coming in August | RAPS:

"For companies that compound human drugs in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (i.e., human drug compounders that are not registered with FDA as outsourcing facilities under section 503B), effective 1 August 2016, “FDA investigators will make a preliminary assessment of whether such entities are compounding their human drugs in accordance with certain conditions of section 503A before closing the inspection.”"

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Read the details of the FDA Notice (PDF)

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Major shift ahead in how FDA regulates drug quality: PwC

• Recommended FDA cGMP online training programs and courses by SkillsPlus Intl Inc.

Updated June 27, 2022

The link to the original source article broke.

---  the original post follows below  ---

FDA Drug Quality Report - Major shift ahead in how FDA regulates drug quality: PwC:

"Parts of the pharmaceutical industry continue to struggle with drug quality. A major shift in the way the FDA oversees drug quality could pose new challenges for companies with inadequate control over their manufacturing facilities and supply chains."

'via Blog this'

Read the PwC report:
Major shift ahead in how FDA regulates drug quality (PDF)

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Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

FDA Amends Drug Shortage Regulations

Read the full text final rule: Federal Register | Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products:

"The rule requires all applicants of covered approved drugs or biological products—including certain applicants of blood or blood components for transfusion and all manufacturers of covered drugs marketed without an approved application—to notify FDA electronically of a permanent discontinuance or an interruption in manufacturing of the product that is likely to lead to a meaningful disruption in supply (or a significant disruption in supply for blood or blood components) of the product in the United States."

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FDA slaps U.S. drugmaker over drug testing issues - FiercePharma Manufacturing

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

Read the full article: FDA slaps U.S. drugmaker over drug testing issues - FiercePharma Manufacturing:

"Inspectors were particularly troubled with batch testing after inspectors found "multiple incidents of inaccurate batch production records containing erroneous statements, including results that were not derived from analytical testing" or from certificates of analysis (CoAs) of its suppliers."

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You might also be interested in the following GMP training course:

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Ex-Homeland Security cyber chief warns of threats to outsourcing firms - Outsourcing Pharma

Read the full article: Ex-Homeland Security cyber chief warns of threats to outsourcing firms - Outsourcing Pharma:

. . . "drug companies should consider the weaknesses in all their relationships, from research contracts to materials supply, big data, logistics, cloud solutions such as SalesForce used by sales and marketing companies, and file-sharing services."

'via Blog this'

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CGMP Training - GMP Essentials for Drug Manufacturers

Updated Febrruary 27, 2026:

The original link broke.

People also need basic FDA CGMP online training courses taught by SkillsPlus International Inc.

---  the original post follows below  ---

GMP Essentials for Drug Manufacturers - An Onsite GMP Training Course

Intended for: 

• new employees and non-cGMP transfers who need basic cGMP training, or
• current staff or those individuals needing refresher training.

This highly interactive course gets everybody talking about current CGMP practices, underlying laws and regulations, the consequences of non-compliance, and recent trends. Many CGMP principles are experienced hands-on in this session. This course is usually customized to meet the needs of the organization, and can be designed to run over 1-3 days. Call (415) 948-5220, to discuss your specific needs. 

Read the feedback:

• The exercises were great! 
• The lack of excessive breaks was a great time saver.
• Lively and friendly
• The instructor's experience was very helpful. 
• Group activities helped in the learning. 
• It never dragged on. 
• Allan seems to know when to move on. 
• Teacher was great! 
• Content explained clearly 
• A nice balance of PowerPoint and activities 
• This class helped me see where we need to make changes in what we are doing. 

Learn more about this onsite cGMP training course, GMP Essentials for Drug Manufacturers - GMP training by SkillsPlus Intl Inc. 

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Obama: Let's Take Food Regulation out of FDA | RAPS

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

Read the full article: Obama: Let's Take Food Regulation out of FDA | RAPS:

"The proposal, contained within Obama's budget proposal for fiscal year 2016, would consolidate all regulatory authority for food under a "single new agency within The Department of Health and Human Services," according to the budget.

"This new agency would be independent from FDA and have primary responsibility for food safety inspections, enforcement, applied research, and outbreak response and mitigation," the White House explains in the budget. "The new agency would be charged with pursuing a modern, science-based food safety regulatory regime drawing on best practices of both agencies, with strong enforcement and recall mechanisms, expertise in risk assessment, and enforcement and research efforts across all food types based on scientifically supportable assessments of threats to public health. The agency would also serve as the central point for coordinating with State and local entities and food safety stakeholders.""

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Poor Quality Drugs and Global Trade: A Pilot Study - NBER.org

Read the rest of the abstract: Poor Quality Drugs and Global Trade: A Pilot Study - NBER.org:

"Experts claim that some Indian drug manufacturers cut corners and make substandard drugs for markets with non-existent, under-developed or emerging regulatory oversight, notably Africa. This paper assesses the quality of 1470 antibiotic and tuberculosis drug samples that claim to be made in India and were sold in Africa, India, and five mid-income non-African countries. We find that 10.9% of those products fail a basic assessment of active pharmaceutical ingredients (API), and the majority of the failures are substandard (7%) as they contain some correct API but the amount of API is under-dosed. The distribution of these substandard products is not random: they are more likely to be found as unregistered products in Africa than in India or non-African countries."

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Read the study paper:
Poor Quality Drugs and Global Trade: A Pilot Study (Roger Bate, Ginger Zhe Jin, Aparna Mathur, Amir Attaran). NBER Working Paper No. 20469. Issued in September 2014 (PDF)

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FDA > Drug Supply Chain Integrity > Verify Wholesale Drug Distributor Licenses

• Buy California Designated Representative Training:
     Wholesaler Course | 3PL Course | Reverse Distributor Course

Follow the link below to see a list of the U.S. state agencies responsible for drug wholesaler licensing. The list is organized by: State, Agency Name, and Website Link or Contact Info.

Drug Supply Chain Integrity > Verify Wholesale Drug Distributor Licenses - FDA:

"U.S. State Agencies Responsible for Licensing Wholesale Prescription Drug Distributors" ...

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You might also be interested in drug wholesaler-related training & resources:

• California Designated Representative online training by SkillsPlus Intl Inc 
• Florida Certified Designated Representative (CDR) online exam prep course
• The Designated Representative Institute

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Related articles

• FDA - Drug Integrity and Supply Chain Security - Another counterfeit cancer medicine found in U.S. - Illegal practice puts patients at risk (drughealth.blogspot.com)
• FDA Awards Two New Regulatory Research Centers (drughealth.blogspot.com)

Make A New Year Resolution - Take A GMP Trainer Certification Course

Updated December 19, 2025

You might also be interested in the online distance learning version of our highly popular GMP Trainer Certification Course - taught by SkillsPlus International Inc:

GMP Trainer Awareness, Certification, and Master Trainer Courses

. 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.

- - -   original post follows below   - - -

SkillsPlus Intl Inc.'s next public seminar of the highly popular GMP Trainer Certification Course is May 5-9, 2014 in Fort Lauderdale, FL.  Learn more: http://www.skillsplusinc.com/Pub_Sem.htm

This is a life-changing five-day class in which participants experience many different ways to teach CGMPs and QSRs. Learn what your instructor is thinking about during sessions, so that you can repeat that training approach in your organization.

Students make 2 presentations demonstrating their skills during the class. This class is suitable for food and dietary supplement manufacturers also.

1. Upon course completion, participants will be able to:
2. Explain the essentials of the CGMP/QSR regulations. 
3. Use the philosophical basis for the rules and interpretation to respond to CGMP/QSR related questions. 
4. Demonstrate techniques to present CGMP/QSR content in memorable ways.
5. Design and conduct activities that reinforcement learning. 
6. Facilitate discussions and questions like a pro. 
7. Respond to difficult questions.
8. Deal successfully with difficult students. 
9. Manage class room media. 

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FDA Prepares Compounding Blacklist of Banned Products - RAPS RF

• People also ask about FDA GMP Online Training - respected FDA CGMP online training courses provided by SkillsPlus International Inc.

FDA Prepares Compounding Blacklist of Banned Products - RAPS RF:

"In a Federal Register announcement on 2 December 2013 — just days after the DQSA was signed into law — FDA said it wanted public input on which drugs should comprise such a list.

"To identify candidates for the difficult-to-compound list, FDA is seeking public input in the form of specific drug products or categories of drug products that are difficult to compound," the agency wrote."

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The Best GMP Trainers are . . .

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.

--- original post follows below  ---

If you're a trainer, here's some food for thought.

Rob Packard of the Medical Device Academy was quoted on LinkedIn, "that there are four prerequisites for a great Instructor:

1. The instructor must be an expert.
2. The instructor must inspire participation.
3. The instructor must provide practical examples for each student.
4. The instructor must get everyone’s attention – and keep it."

If Rob's wise words resonate with you, then consider joining us for our highly recommended, and extremely popular GMP Trainer Certification Public Seminar (click to learn more). 

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FDA Proposal - Head Off More Drug Shortages

Updated December 19, 2020

You might be more interested in this:

Drug Shortages - FDA.gov

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FDA proposal aims to head off more drug shortages:

"The Food and Drug Administration announced a new proposal Thursday to try and head off more shortages of crucial medications that have disrupted care at hospitals and clinics nationwide.

Under the proposed rule, companies that make medically important prescription medicines would have to notify the FDA six months ahead of any changes that could disrupt the U.S. supply. That includes plans to discontinue a product or manufacturing changes that could slow production."

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Food or Dietary Supplement - Therapeutic Claims = Drugs

FDA Law Blog: Using Scientific Literature in Food or Dietary Supplement Marketing? Proceed with Caution:

"Recent actions by FDA and the FTC serve as reminders that both agencies will consider the use of scientific literature in determining whether marketing for a food or dietary supplement conveys disease treatment or prevention.

FDA recently issued a warning letter to a company that sells eye health dietary supplements. FDA alleged that the company’s website included “therapeutic claims” that established that its products were unapproved new drugs."

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How To Become A Better GMP Trainer

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.

--- original post follows below  ---

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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FDA Final Rule on Combo Product CGMPs - New!

Fda (Photo credit: Wikipedia)

Hot off the press!

This final rule clarifies which CGMP requirements apply when drugs, devices, & biological products are combined to create combination products:

Current Good Manufacturing Practice Requirements for Combination Products - A Rule by the Food and Drug Administration on 01/22/2013

In a nutshell:

The FDA is issuing this regulation on the current good manufacturing practice (CGMP) requirements applicable to combination products. This rule is intended to promote the public health by clarifying which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products. In addition, the rule sets forth a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with CGMP requirements for "single-entity" and "co-packaged" combination products.

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Related articles

• FDA - Proposed Rules To Implement FSMA (skillsplusinfo.blogspot.com)

FDA Adopts ICH Q11 (Development & Manufacture of Drug Substances)

• FDA GMP Online Training - respected cGMP online training classes offered by SkillsPlus International Inc.

The Food and Drug Administration (FDA) posted a guidance entitled “Q11 Development and Manufacture of Drug Substances.” The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes approaches to developing and understanding the manufacturing process of a drug substance and provides guidance on what information should be provided in certain sections of the Common Technical Document (CTD). The guidance is intended to harmonize the scientific and technical principles relating to the description and justification of the development and manufacturing process of drug substances (both chemical entities and biotechnological/biological entities). The discussion of principles in the guidance is intended to apply only to the manufacture of drug substance, not the manufacture of finished drug products.

Related Links:

• FDA Guidance for Industry - Q11 Development and Manufacture of Drug Substances (PDF)
• ICH Q11 - Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological Biological Entities)  (this links navigates to a page containing Q11-related documents)

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• FDA - ANDA Stability Testing - New Draft Guidance Document (skillsplusinfo.blogspot.com)

Consider On-Site Training - Popular GMP Classes and QSR Courses

Updated March 10, 2021

Given the COVID-19 pandemic, you might also be interested in CGMP online training:

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

- - -

Comprehensive master training plans often take advantage of a 'blended' training approach . That is, a mixture of multiple training modalities, including online training and live instructor-led classes.

As 2013 approaches, you might want to consider and/or justify bringing in SkillsPlus Intl Inc. to deliver your on-site in-person training classes.

Learn more about SkillsPlus Intl Inc On-Site QSR Classes & GMP Training Courses

Consider these features and benefits of live, on-site, in-person training.

Convenient, Flexible, & Interactive 

• You get to pick the date, time, & location – adjust for shifts, or number of days that works best for your employees; select your facility, plant, training center, or other desired location 
• In-person training engages students – with the right instructor on-site training encourages interaction according to class size and level of training, ensures consistent messages, and fosters team building 

Content That Fits Your Needs 

• Your training needs are addressed - training content & activities are adjusted, based on students’ prerequisite & current skill levels, and the organization’s specific needs, objectives, issues, and challenges. Tailoring the content ensures that training is unique & relevant. 
• Confidential issues can be covered - Training on-site means you can candidly discuss your organization's unique challenges and opportunities. Sensitive company information can be shared by participants and used as concrete examples during interactive and workshop sessions in complete confidence. 

Great Value 

• Avoid having to leave the building - Without ever leaving the building, staff can gain new skills, boost their confidence, and improve their productivity. Since on-site training takes place at client’s premises, there is no travel, no time away from the plant, and no unrelated expenses that are often associated with public courses (e.g. travel, hotel, subsistence, etc.). 
• You get live in-person expert instruction! The best on-site teachers are skilled facilitators and/or consultants. With the right instructor, you get the added advantage of getting expert advice alongside the training.

You won't be disappointed by selecting SkillsPlus Intl Inc. to deliver your on-site training. Our past students say that they love our interactive style, learn a lot that they can put into immediate use, and recommend us to their industry friends.

Learn more about SkillsPlus Intl Inc On-Site QSR Classes & GMP Training Courses

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