Showing posts with label gmp training. Show all posts
Showing posts with label gmp training. Show all posts

Monday, August 18, 2014

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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Tuesday, July 15, 2014

FDA Gives Guidance On Compounding For Human Use - mondaq

Updated April 19, 2022

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---  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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Wednesday, June 25, 2014

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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Friday, June 6, 2014

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

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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Wednesday, May 21, 2014

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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Friday, May 16, 2014

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

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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Thursday, May 8, 2014

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

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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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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Wednesday, May 7, 2014

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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Friday, April 25, 2014

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

Updated July 1, 2025

The original link broke.

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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

- - -  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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Wednesday, April 16, 2014

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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Wednesday, April 9, 2014

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.

Wednesday, March 19, 2014

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

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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Friday, March 14, 2014

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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Tuesday, February 25, 2014

Executive Session - An Advanced GMP Training Course


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.

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


Monday, February 24, 2014

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

Updated December 19, 2025

You might be interested in:

---  the original post follows below  ---

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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Thursday, February 20, 2014

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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Thursday, February 6, 2014

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

Updated February 27, 2026:

The GMP Olympics course is no longer available.

You might also like the best and recommended choice 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 | Recommended | Respected | Popular | The best choice for FDA CGMP online training courses and programs.

---  the original post follows below  ---
Upd
  • 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! 

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