FDA Studying How it Can Use Drones to Conduct Inspections | RAPS

Read the full article: FDA Studying How it Can Use Drones to Conduct Inspections | RAPS:

"While there is currently "no formal drone program in development," the agency is currently "conducting preliminary feasibility testing on possible applications for drone technology in fulfillment of the agency's mission," Andrea Fischer, an FDA spokeswoman, told Focus.

Using drones during FDA inspections of manufacturing facilities could have far-ranging implications. Inspections could, for example, much more easily survey an entire manufacturing site, which can sometimes span several acres and include difficult-to-access sections, such as rooftops. In agricultural settings, in particular, the use of drones might allow FDA to survey an entire site much more easily."

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The DSCSA Standards Guidance is here! « Ag/FDA Blog

Read the full article: The DSCSA Standards Guidance is here! « Ag/FDA Blog:

"With trading partners required on January 1, 2015, to begin exchanging transaction data when covered pharmaceuticals change owners, guidance from the agency was imperative. FDA specifically recognizes that, although the guidance is a “draft,” “the DSCSA clearly intends for stakeholders to rely upon this draft guidance document before finalization.”  As such, FDA is immediately implementing the Draft Guidance."

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Read the draft guidance:
DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information (PDF - 85KB)

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FDA Law Blog: DOJ Announces Another GMP Consent Decree for a Dietary Supplement Manufacturer

Read the full article: FDA Law Blog: DOJ Announces Another GMP Consent Decree for a Dietary Supplement Manufacturer:

"These cases show that FDA will aggressively pursue violators of the dietary supplement GMP requirements.   Because the consent decrees include a recall provision, a shut-down provision, and a requirement that FDA confirm that they are in compliance before they can reopen, the companies may well end up being put out of business permanently.

FDA does not bring a lot of injunction cases per year.  Four (or more) injunctions related to dietary supplement GMP suggests that this area is a high enforcement priority for the Agency."

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• 
   

FDA - News & Events > From our perspective: Assessing, safeguarding pharmaceutical quality

• People also search for FDA GMP QSR cGMP Online Training: FDA cGMP QSR GMP Online Training - popular online training courses by SkillsPlus International Inc. #FDA #cGMP #GMP #QSR #training
  

Updated March 25, 2021

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The Collection | From Our Perspective - FDA.gov

---  original post follows below  ---

Read the full article: News & Events > From our perspective: Assessing, safeguarding pharmaceutical quality - FDA.gov

"Lucinda Buhse, PhD, acting director, Office of Testing and Research, Office of Pharmaceutical Science, discusses efforts underway in FDA’s laboratories to help assure high-quality drug products are available for the public."

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The article covers:

• Assessing pharmaceutical quality
• Measuring pharmaceutical quality across the drug lifecycle
• FDA’s additional roles in safeguarding quality
• Research and innovation in CDER’s drug quality testing program
• Continuing to help protect consumers from harm

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FDA - Constituent Updates > New CFSAN Center Director Announced

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Read the full article: Constituent Updates > New CFSAN Center Director Announced - FDA.gov:

"The U.S. Food and Drug Administration today announced a change in leadership at the Center for Food Safety and Applied Nutrition. In January 2015, Dr. Susan T. Mayne will take the reins from Michael M. Landa, who has led the Center since 2010, providing critical leadership on major food safety and nutrition initiatives.

Mayne is an internationally recognized public health leader and scientist, who is also known as an outstanding administrator and coalition builder. With rigorous training in nutrition, toxicology, and epidemiology, she understands the fundamental relationship between science and FDA’s public health mission"

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It's Not Just You: FDA Regulatory Requirements Really Are Increasing | RAPS

Read the full article: It's Not Just You: FDA Regulatory Requirements Really Are Increasing | RAPS:

"According to data made available by George Mason University's Mercatus Center and analyzed by Regulatory Focus, the number of regulatory requirements imposed by the US Food and Drug Administration (FDA) increased by 15% between the years 2000 and 2012.

While regulatory professionals working with FDA needed to know just 16,329 requirements in 2000, they needed to know 18,777 in 2012, according to the data."

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Federal Register | FDA Guidance for Industry on Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection; Availability

Federal Register | Guidance for Industry on Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection; Availability:

"FDA is announcing the availability of a guidance for industry entitled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection.” On July 9, 2012, FDASIA (Pub. L. 112-144) was signed into law. Section 707 of FDASIA adds 501(j) to the FD&C Act to make a drug adulterated that “has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.” As required by Section 707, FDA is issuing this guidance to define the types of action, inaction, and circumstances that FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of Section 501(j) of the FD&C Act."

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Read the FDA Final Guidance:
Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection (PDF - 106KB)

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Reports > FDA Strategic Priorities: 2014 - 2018 - FDA.gov

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Read the full article: Reports > FDA Strategic Priorities: 2014 - 2018 - FDA.gov:

"This Strategic Priorities document articulates the goals and priorities that guide our Agency. It creates a framework that will allow us to integrate and achieve our five strategic priorities – regulatory science, globalization, safety and quality, smart regulation, and stewardship.

While the priorities are individually important, they are also interconnected and cannot be addressed in isolation. Thus, for example, regulatory science is at the core of everything FDA does and therefore it influences and in turn is affected by any actions taken involving the other priorities. The cross-cutting nature of this plan will help FDA achieve the greatest benefits.

This document also sets forth FDA’s core mission goals and objectives, such as improving and safeguarding access to – and making better informed decisions about – the products FDA regulates. It describes in detail key strategies to help the Agency fulfill its public health mission."

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The FDA takes steps to strengthen cybersecurity of medical devices - FDA.gov

Read the full press release:  Press Announcements > The FDA takes steps to strengthen cybersecurity of medical devices - FDA.gov:

"To strengthen the safety of medical devices, the U.S. Food and Drug Administration today finalized recommendations to manufacturers for managing cybersecurity risks to better protect patient health and information.

The final guidance, titled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” recommends that manufacturers consider cybersecurity risks as part of the design and development of a medical device, and submit documentation to the FDA about the risks identified and controls in place to mitigate those risks. The guidance also recommends that manufacturers submit their plans for providing patches and updates to operating systems and medical software."

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Guidance Outlining Up to 10 Quality Metrics Expected by Year’s End: FDA Official | 2014-09-26 | FDANews

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Guidance Outlining Up to 10 Quality Metrics Expected by Year’s End: FDA Official | 2014-09-26 | FDANews:

"The FDA is honing in on roughly eight to 10 quality metrics that the agency plans to collect from drugmakers starting in 2015, and expects to publish a guidance that names them by the end of the year."

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Foresight is 20/20: The Need For Pharmaceutical Companies to Implement Robust Anti-Corruption Programs - Pharmaceutical Compliance Monitor

Updated September 4, 2024

Unfortunately, the original link broke.

---  the original post follows below  ---

More insights in the full article: Foresight is 20/20: The Need For Pharmaceutical Companies to Implement Robust Anti-Corruption Programs - Pharmaceutical Compliance Monitor:

"In the wake of the recent FCPA enforcement activity, the government has signaled its renewed attention to pharmaceutical companies. It is therefore imperative that pharmaceutical companies doing business abroad assess their individual risks, develop compliance goals, and create and implement a comprehensive compliance program that evolves in conjunction their risk profile and ever-changing enforcement trends."

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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 could be source of innovation, Hamburg says - Denver Business Journal

Read the full article: FDA could be source of innovation, Hamburg says - Denver Business Journal:

"The FDA, in the course of approving new drugs and devices and overseeing their safety and effectiveness, gains broad knowledge of what companies are doing, what researchers are discovering about disease and how that relates to medical outcomes.

Hamburg’s vision is for the FDA to use that position to help researchers and companies make more effective new treatments and prove new medical advances more quickly, she said.

“We have a lot more to offer than has historically been appreciated,” said Hamburg, U.S. Commissioner of Food and Drugs since 2009. “The regulator has a very different role than the innovator or the academic researcher, but we can be a very effective partner for both.”"

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FDA - Biosimilars > Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations

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Read the full announcement: Biosimilars > Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations - FDA.gov:

"The Purple Book will also enable a user to see whether a biological product licensed under section 351(k) of the PHS Act has been determined by FDA to be biosimilar to or interchangeable with a reference biological product (an already-licensed FDA biological product). Biosimilar and interchangeable biological products licensed under section 351(k) of the PHS Act will be listed under the reference product to which biosimilarity or interchangeability was demonstrated.

Separate lists for those biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) will be updated periodically."

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Virulent Chinese Hacking Group Mows Through U.S. Medtech, Pharma - Washington Post

Updated February 26, 2021

Links in the original post broke.

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Virulent Chinese hacking group mows through U.S. health industries - SCNOW

- - -  original post follows below  - - -

Read the full article: Virulent Chinese Hacking Group Mows Through U.S. Medtech, Pharma - Washington Post Business Page, Business News:

"The breaches have forced companies to boost efforts to protect their computer banks. On average, health-care companies spent $2.2 million on information security in 2013, a more than 20 percent increase from the prior year, according to a PwC, CIO and CSO magazine survey.

“I recently met with three CEOs in health care and in most cases they had come to the conclusion that they definitely did under-invest,” said Mick Coady, a partner at PwC’s health information privacy & security group. “Health care is at least a decade, if not more, behind.”"

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FedEx Faces Money-Laundering Charge in Revised Indictment - Bloomberg

Read the full article: FedEx Faces Money-Laundering Charge in Revised Indictment - Bloomberg:

"The allegations of a conspiracy to launder money were included in a revised indictment against the company filed today in federal court in San Francisco. FedEx and individuals who ran the illicit pharmacies “knowingly and intentionally” schemed to launder more than $630,000 in shipping payments that were derived from drug sales, federal prosecutors said in the indictment.

The government has said that FedEx and its co-conspirators could face a fine of twice the gains from the conduct, alleged to be at least $820 million."

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FDA Abroad - Pharmaceutical Executive

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Read the full article: FDA Abroad - Pharmaceutical Executive:

"In India, America's second largest global source of API and finished drug products, some 1,965 manufacturing facilities export to the US, but only around 600 sites are registered with CDER, said Atul Agrawal, supervisory consumer safety officer at FDA's India office. Drug manufacturing capability in India doubled to represent 12% of total US drug imports in 2012, up from 6% in 2008. "India is a major player in the prescription drugs Americans take on a daily basis," said Agrawal, much to the envy of Chinese nationals everywhere. And yet, FDA's operation in India currently consists of five full-time Americans, and two locally employed staffers, spread across two offices, one in New Delhi and one in Mumbai."

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U.S. Seeks Legislation to Curb Offshore Tax Deals - Bloomberg

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

Read the full article: U.S. Seeks Legislation to Curb Offshore Tax Deals - Bloomberg:

"In a letter calling for a “new sense of economic patriotism,” Treasury Secretary Jacob J. Lew said Congress should approve tax changes retroactive to May.

“We should prevent companies from effectively renouncing their citizenship to get out of paying taxes,” Lew wrote in the letter to top congressional tax writers, which was dated yesterday and obtained by Bloomberg News. “We should not be providing support for corporations that seek to shift their profits overseas to avoid paying their fair share of taxes.”

The mergers used to legally avoid taxes, known as inversion transactions, have become increasingly popular over the past year, particularly in the pharmaceutical industry. "

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FDA Gives Guidance On Compounding For Human Use - mondaq

• Buy FDA GMP Online Training - trusted FDA CGMP online training classes delivered by SkillsPlus International Inc.

Updated April 19, 2022

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Compounding Quality Center of Excellence On-demand Training - FDA.gov

---  the original post follows below  ---

Read the full article: FDA Gives Guidance On Compounding For Human Use - Food, Drugs, Healthcare, Life Sciences - United States - mondaq:

"In July 2014, the U.S. Food and Drug Administration (FDA) released five documents containing policies and proposals that affect both traditional compounding pharmacies and outsourcing facilities that compound drugs for human use. These documents are:

• Draft Interim Guidance setting forth FDA's current thinking as to its interim expectations for outsourcing facilities regarding compliance with Current Good Manufacturing Practices (CGMP) until regulations are developed; 
• A Proposed Rule adding 25 new drug products to the "do-not-compound" list, for both traditional compounders and outsourcing facilities; 
• Final Guidance for traditional compounders; and 
• Two separate requests, one for 503A and one for 503B, to nominate bulk drug substances for FDA lists of active bulk substances that traditional compounders and outsourcing facilities are permitted to use."

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Nanotechnology > FDA Issues Three Final Guidances Related to Nanotechnology Applications in Regulated Products, Including Cosmetics and Food Substances

Follow the link below to a webpage that contains links to the 3 final guidances.

Read the full article: Nanotechnology > FDA Issues Three Final Guidances Related to Nanotechnology Applications in Regulated Products, Including Cosmetics and Food Substances - FDA.gov:

"In June 2014, FDA issued three final guidance documents reflecting FDA’s current thinking on certain issues related to the use of nanotechnology in FDA-regulated products. FDA prepared these final guidances after taking into account public comment received on the corresponding draft guidance documents previously issued in 2011 and 2012. These guidance documents are being issued as part of FDA’s ongoing implementation of recommendations from FDA’s 2007 Nanotechnology Task Force Report."

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Pure Food and Drug Act passes in Congress, June 23, 1906 - POLITICO.com

English: Theodore Roosevelt, circa 1902 (Photo credit: Wikipedia)

Read the full article: Pure Food and Drug Act passes in Congress, June 23, 1906 - Andrew Glass - POLITICO.com:

"On this day in 1906, the Pure Food and Drug Act cleared a hurdle toward its passage when the House and Senate both endorsed a joint conference committee report favoring the bill. The House vote was 240-17. President Theodore Roosevelt signed the landmark Progressive Era legislation into law on June 30.

The statute for the first time regulated food and drugs that moved in interstate commerce and forbade the manufacture, sale or transportation of poisonous patent medicines. It arose, with strong White House support, in the wake of exposés by such muckrakers as Upton Sinclair and Samuel Hopkins Adams."

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SecuringIndustry.com - USP starts field trials of FDA fake drug screening device

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Read the full article: SecuringIndustry.com - USP starts field trials of FDA fake drug screening device:

"The US Pharmacopeial Convention has started field testing a new low-cost screening device designed to detect counterfeit and poor quality medicines quickly.

The handheld CD-3+ unit - originally developed by the US Food and Drug Administration (FDA) - uses multiple light sources to look at packaging using different wavelengths and provide images that can be interpreted by the user to differentiate between genuine and falsified medicines. The approach may also be applicable to individual tablets."

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FDA launches openFDA to provide easy access to valuable FDA public data

• Respected FDA CGMP online training courses and programs taught by SkillsPlus International Inc.

Updated October 7, 2021

The original link broke.

You can still read about the same topic here:

FDA launches openFDA to provide easy access to valuable FDA public data - WorldPharmaNews

---  the original post follows below  ---

Read the full article: Press Announcements > FDA launches openFDA to provide easy access to valuable FDA public data:

"Today, the U.S. Food and Drug Administration launched openFDA, a new initiative designed to make it easier for web developers, researchers, and the public to access large, important public health datasets collected by the agency.

In alignment with the recent Presidential Executive Order on Open Data and the Department of Health and Human Services Health Data Initiative, openFDA will make the FDA’s publicly available data accessible in a structured, computer readable format that will make it possible for technology specialists, such as mobile application creators, web developers, data visualization artists and researchers to quickly search, query, or pull massive amounts of public information instantaneously and directly from FDA datasets on an as needed basis."

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Go to: openFDA

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Improving Documentation of GMP Procedures - Natural Products Insider

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

Follow the link below to read Richard Soltero's full article, written for dietary supplement manufacturers.

Improving Documentation of GMP Procedures - Natural Products Insider:

"Here are a few key GMP guidelines that help manufacturers avoid FDA citations and sanctions:

• Document all procedures in manufacturing operations.
• Maintain all records for plant and equipment cleaning processes.
• Mandate techniques for product sampling.
• Ensure approval by QC personnel for all procedures, tests, controls and deviations.
• Implement a control process for product labeling.
• Require QC personnel to provide results of initial or final products.
• Provide a procedure to follow if documented specifications are not met.
• Retain all written documentation for at least one year past the shelf life of the product or two years past the dissemination date of the last batch of dietary supplements."

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FDA warning letter says Sun Pharma plant hid batch failures - FiercePharma Manufacturing

Sun Pharmaceutical wants to buy long-troubled Ranbaxy Laboratories.

FDA warning letter says Sun Pharma plant hid batch failures - FiercePharma Manufacturing:

"A warning letter for a now banned Sun Pharmaceutical plant in India, posted today by the FDA, shows employees routinely deleted records of batch failures then retested drugs, reporting they met the standards that they previously couldn't hit. In fact, FDA inspectors fished torn and partially destroyed raw data cGMP records out of the trash."

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Warning Letters (2012 – Q1 2014) Show FDA’s GMP Enforcement Shifting Overseas | IPQ Newsletter

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Warning Letters from 2012 – Q1 2014 Show FDA’s GMP Enforcement Focus Shifting Overseas; Foreign Labs Draw Particular Attention | IPQ Newsletter:

"In 2012, for the first time, foreign warnings began outpacing those issued domestically. Between 2012 and the first quarter of 2014, 48 drug GMP warning letters were issued internationally compared to 44 in the U.S. [Editor's Note:  At the end of the story is a chronological listing of all 92 of the drug GMP warning letters issued between the beginning of 2012 and the first quarter of 2014, categorized into U.S. and International. The key concerns that each of the warning letters address and links to the letters themselves are provided.]"

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17 Awesome Resources on Micro-Learning - eLearning Industry

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17 Awesome Resources on Micro-Learning - eLearning Industry:

"Micro learning is learning in small steps (contrary to the traditional approach of learning through hour-long courses). It is made possible with the aid of small, well planned, bite-sized chunks of units or activities (also called learning nuggets) that are short-term, digestible, and easily manageable. ...

Micro learning is going to be the future of learning. It is all set to transform how we learn both for our personal as well as our professional needs. We foresee micro learning tools evolving into an essential component of any enterprise learning toolbox. "

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Root Cause Analysis - GMP Training

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

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     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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• 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)

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 December 8, 2020

The original link broke.

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FDA’s Proposed Regulation of Additional Tobacco Products Missing Critical Components - Public Health Law Center at Mitchell Hamline School of Law

- - -  original post follows below  - - -

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.

--- original post follows below  ---

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."

'via Blog this'


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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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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!

 

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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Executive Session - An Advanced GMP Training Course

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

Updated July 30, 2024

Sadly, "Executive Session" is no longer available.

- - -

EXECUTIVE SESSION - a cGMP training course
- #FDA #GMP #cGMP #QSR #advanced #training #course

Executive Session is an advanced course that addresses CGMP & QSR issues directly relevant to the executive leadership and executive teams of manufacturers.

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Related articles

• Do You Have SOP Compliance Problems? (drughealth.blogspot.com)
• 2014 GMP Training Ideas - Executive Session (2014 cGMP Updates) (drughealth.blogspot.com)
• GMP Training - Olympic-Style (drughealth.blogspot.com)

Analytical Procedures and Methods Validation for Drugs and Biologics - New FDA Draft Guidance

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

Updated September 6, 2022

Here's the latest version of the guidance:

Analytical Procedures and Methods Validation for Drugs and Biologics - Guidance for Industry - FDA.gov

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FDA Guidance for Industry Analytical Procedures and Methods Validation for Drugs and Biologics - DRAFT GUIDANCE (February 2014 - PDF):

"This revised draft guidance supersedes the 2000 draft guidance for industry on Analytical Procedures and Methods Validation and, when finalized, will also replace the 1987 FDA guidance for industry on Submitting Samples and Analytical Data for Methods Validation. It provides recommendations on how you, the applicant, can submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products. It will help you assemble information and present data to support your analytical methodologies."

Source:

• Guidance for Industry: Analytical Procedures and Methods Validation for Drugs and Biologics (PDF - 359KB)

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Root Cause Investigations Workshop - GMP Training

ROOT CAUSE INVESTIGATIONS WORKSHOP
#FDA #GMP #QSR #cGMP #training #course #class

Learn how to dig deeper and discover what's really below the surface. In this course, students apply root cause analysis tools to real in-plant deviations.

Learn more: http://www.skillsplusinc.com/root_cause.htm

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Certified Designated Representative

Florida Certified Designated Representative (CDR)

 CERTIFIED DESIGNATED REPRESENTATIVE
"All prescription drug wholesale distributor and out-of-state prescription drug wholesale distributor permittees and applicants must designate in writing at least one natural person to serve as the designated representative for a given establishment.  Such person must have an active certification from the department (a “certified designated representative” or “CDR”)." [Source: Florida Certified Designated Representative: - 'via Blog this']

Go to:  The Designated Representative and Exemptee Blog

FL Certified Designated Representative online e-Learning exam preparation by SkillsPlus Intl Inc.
CA Designated Representative online web-based training certification by SkillsPlus Intl Inc - Available around-the-clock 24 x 7 
The Designated Representative Institute

CA HMDR Exemptee online internet-based training certification by SkillsPlus Intl Inc 
The Exemptee Institute

SkillsPlus Intl Info Blog

FDA Orange Book 2014 - 34th Edition

The 2014 FDA Orange Book (34th Edition) is hot off the press.

This 34th edition of the FDA Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) is current through December 31, 2013.

View the Orange Book:
FDA Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) - PDF

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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!

 

Tired Of Boring Training? Then Feel The Thrill of the GMP Olympics!

#FDA #GMP #QSR #cGMP #training #course #class

• Do your employees avoid CGMP training, claiming they've heard it all? 
• Do they resist attending CGMP training because "their" job is never discussed? 
• Do some employees "drift off" in CGMP training because it is too theoretical? 

If you answered "Yes" to any of these questions, then you need to take a look at our GMP Olympics Refresher course.

Featured Course: GMP Olympics 
Participate in the Olympics! This course challenges even the most seasoned employee's knowledge of CGMPs. This course is definitely not for employees who are new to the industry.

Activities from this highly interactive workshop include:

• Heard on the Street 
• Team-based regulation review 
• GMP Challenge 
• Inspection Detection, and more! 

This course can be customized to meet a variety of content and time constraints.

Learn more: GMP Olympics – Course Outline

Allan Dewes, President. About Your Instructor Allan Dewes    Allan Dewes has been training employees for over 40 years, with 30 years in the pharmaceutical industry. Allan understands CGMP regulations, the FDA expectations, and how to make training fun to maximize retention. Email today to request a quotation

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Related articles

• GMP Training 2014 - Look at this GMP Olympics Refresher Course (drughealth.blogspot.com)
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• Do You Have SOP Compliance Problems? (drughealth.blogspot.com)

Do You Have SOP Compliance Problems? Need Help?

Updated 12/26/2022

The original post got outdated.

You might also be interested in:

FDA cGMP online training courses by SkillsPlus International Inc.

---  the original post follows below  ---

• Do CGMP documents contain many errors, or
• Are change controls often side-stepped, or 
• Is the Quality Unit often side-stepped, or 
• Are procedures not always followed?

If you answered "Yes" to any of these questions, then take a look at our Qualstar: A CGMP Training Simulation course.

Featured Course:   Qualstar - A CGMP Simulation
Designed to teach and to change the culture of companies in order to focus on quality and compliance. This competitive simulation is an eye-opener for participant and executive staff observers alike. Issues addressed in this exciting simulation:

1. Documentation problems
2. Procedures not being followed
3. Change control not practiced
4. QA not consulted on deviations 

If this describes some of your issues, then you need to experience Qualstar!
Examine The Qualstar Outline

Ready? Set? Go! and feel the high energy of this popular and exciting course.

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Related articles

• 2014 GMP Training Recommended: The Qualstar Simulation (drughealth.blogspot.com)
• Once Again, Lack of SOP Compliance Tops List of 483 Observations - BioProcess Blog (drughealth.blogspot.com)

GMP Training Needs To Be Conducted By Trained & 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.

--- original post follows below  ---

English: Training Français : Formation (Photo credit: Wikipedia)

Act now to avoid these common deficiencies:

• Failure to ensure that each person has the education, training and experience to perform their assigned functions
• Failure to document that all personnel are trained to adequately perform their assigned responsibilities

Food For Thought On GMP Trainers:

• cGMP trainers should be trained and qualified instructors who have the required background and experience in the subject matter. 
• Be aware that when “repeated” errors are noted in documents, inspectors will look at training records to see if the trainers have been trained. 
• One documentation approach is to keep resumes of all trainers on file permanently, so that they are available for FDA inspection. 

What Now?:

• Perform an assessment of all trainers against policies and procedures applicable to trainer qualifications.
• If GMP trainers need more training, consider this highly popular workshop:  GMP Trainer Certification Workshop - A Public Seminar offered by SkillsPlus International Inc.

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