We are Proud to Announce
Congratulations to one of our clients - VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center - for receiving the Malcolm Baldrige National Quality Award. We are privileged to share in your success!
The Malcolm Baldrige National Quality Award is the most prestigious Quality Award in the USA. Read a Press Release with details of their accomplishment. VA Cooperative Studies Program Clinical Research
Three Key Considerations in Developing Written Procedures That Work - This article describes three critical gaps to identify and overcome in developing effective written procedures
Good Written Procedures = Compliance - This article describes how to prepare effective written procedures and get everyone to follow them
A Time-tested and Classic Approach to Problem Solving and Problem Prevention - This article describes the application of the Plan-Do- Study-Act cycle to Corrective and Preventive Action activities.
Audit Preparation: A Key Element of an Effective GMP Training Process - This article describes an interactive exercise where groups prepare an audit checklist
Taking Preventive Action: How Asking Good Questions Leads to the Root Cause of Problems - This article describes a method for getting to the root cause(s) of problems when conducting a Corrective and Preventive Action analysis
GMP Compliance: Start with the Basics This article outlines twelve fundamentals of GMP upon which to build an effective GMP Training Program
Turning Problems into GMP Learning Points This article discusses timely GMP training sessions focused on recent problems and issues
Have a Safe Flight This article discusses parallels between the FDA regulated industries and the airline industry. All our customers expect a "Safe Flight" when they buy and use our products
Think Before You Act This article provides strategies for improving your GMP training by incorporating the concept of Thinking before taking Action.
GMP and Quality, Responsibility, Integrity, and Accountability This article describes how to instill these important character traits into your people to assure commitment to GMP
Using Stories, Anecdotes, and Metaphors to Makes Your GMP Training Come Alive This article describes techniques for making your training become memorable experiences
Creating a Culture of Quality and GMP Compliance - This article describes characteristics of companies where Quality and GMP Compliance have become a Lifestyle
GMP Training in a Down Economy: Why It's More Critical Now Than Ever - This article will help you make the case for NOT cutting back on training in tough financial times
GMP Training: Keep it Fresh by Making it Real - This article contains tips on keeping your GMP fresh
GMP and Safety: Employee Safety and Customer Safety - This article discusses how to integate GMP training into your safety training sessions
Practical Preparation for Effective GMP Training Six Steps to Success! - First published in the Journal of GXP Compliance, this article is the first of three parts aimed at developing an effective GMP training process.
Conducting Effective GMP Training: Do’s and Don’ts for Success! - First published in the Journal of GXP Compliance, this is the second of three parts.
Effective Follow-up Strategies to GMP Training - First published in the Journal of GXP Compliance, this is the final of three parts.
A Risk-based Approach to GXP Training: One Size Does Not Fit All - First published in the Journal of GXP Compliance, this article explores developing an effective GMP training process in sync with FDA's new risk-based approach.
A System of Leadership for the 21st Century Lessons from Theodore Roosevelt - An unique perspective building on David's innovative approach of bringing Teddy Roosevelt Back to Life.
Problem Solving is Not Good Enough! Problem Prevention is the Key to Success - Effective use of After Action Reviews.
PDF Good Leaders Are Good Learners - Short article on leadership
PDF How to Make Work More Meaningful for Your Team - Short article on managing your team
PDF Training Your People Pays Off - Short article on the benefits of training
PDF Want Your Employees to Trust You? Show You Trust Them - Short article on management
PDF How to Have Difficult Conversations When You Don't Like Conflict - Short article on leadership
PDF Good Managers Give Constructive Criticism - but Truly Masterful Leaders Offer Constructive Praise - Short article on leadership
PDF Changing Company Culture Requires a Movement, Not a Mandate - Good article on Culture Change using Dr. Reddy's (pharmaceutical manufacturer) as an example of how to accomplish it effectively
PDF Want to Be a Great Leader? Ask Yourself These Questions Weekly - Short article on leadership
PDF 7 Leadership Habits That Are Demoralizing Your Team Without You Realizing It - Short article on leadership
PDF Motivating People Starts with Having the Right Attitude - Short article on motivation
PDF Overcome Resistance to Change with Two Conversations - Short article on change management
PDF 3 Ways to Get More Done Right Now - Short article on time management
PDF 3 Ways to Make Time for the Little Tasks You Never Make Time For - Interesting short article on time management
PDF Playing Well with Others - Teamwork Onstage - Interesting short article on teamwork from the perspective of a rock band
PDF Six Innovation Leadership Skills Everybody Needs to Master - Excellent short article with tips to help you thrive in your career
PDF How to Make Your Employees Masters, and Not Just Workers - Excellent short article with three succinct tips
PDF 20 Things the Most Respected Bosses Do Every Day - Excellent short article on being a successful boss
PDF Why Smart People Don't Multitask - Excellent short article on the perils of multitasking
PDF 7 Reasons the Best Employees Quit, Even When They Like Their Job - Excellent short article on retaining your employees
PDF The Most Important Leadership Competencies, According to Leaders Around the World - Excellent article from Harvard Business Review
PDF Leading Without a Common Why - Excellent short article on engaging your employees
PDF What Bosses Should Never Make Employees Do: The 7 Lamest Moves - Excellent short article published in Inc.
PDF 8 Ways to Become Everyone's Favorite Boss - Excellent short article published in Entrepreneur
PDF Leadership Lessons from Theodore Roosevelt - Excellent short article by James Strock
PDF 9 Things That Makes Good Employees Quit - Excellent article from Inc 42 Magazine
PDF How to be a Rock-Star Employee - Excellent article from inc. Magazine
PDF Your Late Night Emails Are Hurting Your Team - Excellent article from Harvard Business Review
Nelson Mandela's Lessons of Leadership - Excellent article from Time
Are Funny People More Successful in Business? - Forbes article which can be applied to your career and to adding humor to your training sessions
The Shallows - news item about Nicholas Carr's book, The Shallows, about what the Internet may be doing to our brains
Is Google Making Us Stupid? - article by Nicholas Carr
Wooden's Pyramid of Success - John Wooden's Pyramid of Success
The Wisdom of Wooden - Selected quotes from John Wooden
Change is the New Constant: Leading Organizations That (Can) Thrive in Crises - This short ebook describes seven steps for thriving in an unpredictable environment
100 Ways to Kill a Concept: Why Most Ideas Get Shot Down - This short e-book will help you become better at "selling" your ideas and creating a culture of innovation in your workgroup.
Innovation: More Than a New Year's Resolution - This short e-book will help you defy complacency in your work and career.
The Six Core Values of Innovation - This short e-book describes the six core values, or contexts, of innovation.
A Major Mistake That Managers Make - Article by Russ Ackoff, Ph.D.
A Little Book off-Laws: 13 common sins of management - Article by Russ Ackoff, Ph.D.
Transforming the Systems Movement - Article by Russ Ackoff, Ph.D.
From Mechanistic to Social Systems Thinking - Article by Russ Ackoff, Ph.D.
Questionating - This short e-book will help you develop your skill in asking questions. It was W. Edwards Deming who said, "The questions are more important than the answers."
PDF FDA Announces New Steps to Empower Consumers and Advance Digital Healthcare July 2017 - Read this article by Scott Gottlieb, MD, FDA Commissioner
PDF FDA Working to Lift Barriers to Generic Drug Competition June 2017 - Read this article by Scott Gottlieb, MD, FDA Commissioner
PDF Scott Gottlieb, MD confirmed by the US Senate as FDA Commissioner May 2017 - Read an article with details
PDF America's Got Talent - Regulatory Science Style April 2017 - Read about this exciting initiative by the US FDA
PDF FDA in India: Championing a Culture of Quality March 2017 - Read an article from FDA with details
PDF Scott Gottlieb nominated as next FDA Commissioner March 2017 - Read an article with details
PDF Mutual Recognition promises new framework for pharmaceutical inspections for United States and European Union March 2017 - Read FDA's Press Release
PDF Harvey Wiley's Poison Squad and the FDA February 2017 - Read this article published by FDA for a glimpse of the beginnings of the FDA
PDF FDA doesn’t approve companies January 2017 - FDA does not “approve” health care facilities, laboratories, or manufacturers. FDA does have authority to inspect regulated facilities to verify that they comply with applicable good manufacturing practice regulations. Read this notice published by FDA.
PDF FDA issues Guidance for Food Industry - What You Need to Know About the FDA Regulation: GMP, Hazard Analysis, and Risk-based Preventive Controls October 2016 - Read this Guidance Document
PDF FDA issues Guidance on Insanitary Conditions at Compounding Facilities August 2016 - Read this Guidance Document
PDF FDA releases Foods and Veterinary Medicine Program's new Strategic Plan for 2016 - 2025 July 2016 - Read FDA's announcement
PDF FDA celebrates the 40th Anniversary of the Medical Device Amendments June 2016 - These amendments led to the development of GMP for the medical device industry. Read an article and a speech by FDA's Director of the Center for Devices and Radiological Health
PDF FDA issues new draft Guidance on 3D Manufacturing of Devices May 2016 - Read this new draft Guidance Document
PDF FDA issues new draft Guidance on Data Integrity and Compliance with cGMP April 2016 - Read this new draft Guidance Document
PDF FDA issues new Guidance promoting Continuous Manufacturing April 2016 - Read this article by FDA explaining the new Guidance Document
PDF FDA issues new draft guidance - “Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development” March 2016 - Read FDA's announcement with a link to the Guidance Document
PDF FDA making progress on enforcing GMP for Dietary Supplements January 2016 - Read this report by FDA Acting Commissioner Stephen Ostroff, MD
PDF Former CEO of OtisMed Corp. gets prison time July 2015 - Read FDA's Press Release
PDF FDA issues Consent Decree to Medtronic, Inc. April 2015 - Read FDA's Press Release
Commemorating 100 Years of Biologics Regulation - Read this article with relevant history you can use in your GMP training sessions
Small Business Guide to FDA - Download FDA's Small Business Guide
PDF Cellex-C International Inc. Warning Letter August 2017
Read this Warning Letter issued to this Toronto, Canada pharmaceutical company. FDA recommends they hire a CGMP consultant.
PDF Federal judge enters Consent Decree against Utah outsourcing facility Isomeric Pharmacy Solutions August 2017
Read FDA's Press Release with details
PDF National Biological Corporation Warning Letter July 2017
Read this Warning Letter issued to this Ohio medical device firm
PDF Dr. Reddy's Laboratories statement July 2017
Read news article with details - US FDA's observations are "unmistakably" beneficial in the long run and have helped the company accelerate the pace of quality reforms
PDF Raritan Pharmaceutical, Inc. Warning Letter June 2017
Read this Warning Letter issued to this New Jersey pharmaceutical manufacturing firm. Very serious cGMP and misbranding observations.
PDF ChemRite CoPac, Inc. Warning Letter June 2017
Read this Warning Letter issued to this Wisconsin Ohio pharmaceutical manufacturing firm
PDF Magellan Diagnostics, Inc. FDA 483 Observation Report June 2017
Read this Observation Report issued to this Massachusetts medical device firm
PDF New England Compounding Center Exec Sentenced to Prison June 2017
Read news articles with details
PDF FDA Press Release about England Compounding Center June 2017
Read FDA's Press Release
PDF Warning Letter issued to Vikshara Trading and Investments Ltd April 2017
Read this incredible Warning Letter where FDA had to conduct their inspection with flashlights in the dark
PDF Abbott Cardiovascular and Neuromodulation Warning Letter April 2017
Read this Warning Letter
PDF Abbott Cardiovascular and Neuromodulation news article April 2017
Read this article with details
PDF Delta Pharma, Inc. FDA-483 Observation Report March 2017
Read this Observation Report with twelve serious violations
PDF PCM - Pharmacuetical Continuous Manufacturing March 2017
Read an article by USP regarding this technology and applications
PDF Hospira (a Pfizer, Inc. company) Warning Letter February 2017
Read this Warning Letter with citations for Repeat Violations at Multiple Sites
PDF Regeneca Consent Decree February 2017
Read this FDA Press Release announcing a Consent Decree against Regeneca, a California company, for selling products with unsafe ingredients
PDF Regeneca Warning Letter August 2012
Read this Warning Letter that preceded the 2017 Consent Decree
PDF Biocompatibles, Inc. pleads guilty to misbranding November 2016
Read this Press Release from FDA's Office of Criminal Investigations
PDF Nippon Fine Chemical Co. Ltd. Warning Letter September 2016
Read this Warning Letter where the company impeded an FDA inspection
PDF Frontida BioPharm, Inc. Warning Letter August 2016
Read this Warning Letter with major integrity issues
PDF Megafine Pharma Limited Warning Letter May 2016
Read this Warning Letter with major data integrity issues
PDF Emcure Pharmaceuticals Ltd. Warning Letter March 2016
Read this nine-page Warning Letter with multiple violations of GMP
PDF Chemolee Lab Corp. Warning Letter February 2016
Read this Warning Letter with citations for water system failures and lack of cleaning procedures
PDF FDA shifts inspection strategy for drug manufacturers February 2016 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
PDF Two more execs from Peanut Corporation of America get prison terms October 2015
Read the Department of Justice Press Release
PDF Peanut exec in salmonella case gets 28 years September 2015
Read a news article with details
PDF Endoscope deaths investigation extends to cleaning equipment September 2015
Read this news article with details
PDF Update on Endoscope deaths at UCLA August 2015
Read these news articles
PDF More deaths related to contaminated endoscopes Mar 2015
Read this news article with details
PDF FDA weighs in on contaminated endoscopes Feb 2015
Read this article with FDA's thinking on contaminated endoscopes
PDF Contaminated Endoscopes lead to Patient Deaths Feb 2015
Read this article with details about a defective design
PDF New England Compounding Center owners and employees arrested and charged with killing 64 people Dec 2014
Read this disturbing news account
PDF Deerland Enzymes CEO speaks about GMP compliance and the value of third-party audits Nov 2014
Read this article with interesting insights from an industry CEO
PDF Prison time for GMP violators Sept 2014
Read this article regarding the Peanut Corporation of America salmonella contamination case and trial
PDF Draft Guidance: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues August 2016 - Read FDA's Press Release with details and a link to the Guidance Document
PDF Warning Letter issued to Desert Stream Inc. June 2015
Read this 8 page Warning Letter citing very serious violations of GMP
PDF Health One Pharmaceuticals, Inc. Consent Decree Jan 2015
Read FDA's Press Release with details
FDA 483 Observation Report issued to San Francisco Herb and Natural Food Company July 2012 - Read this five page report outlining extensive pest control problems
Reporting an Adverse Event for Dietary Supplements - August 2011 - Updated regulatory information from FDA
FDA New Guidance Document for Dietary Supplements Dec 2010 - cGMP for Dietary Supplement Small Entity Compliance Guide
Public comments accepted by FDA on recordkeeping issues with Dietary Supplement GMP - Read this public notice published in the Federal Register on July 8, 2010
FDA Guidance - Adverse Event Reporting and Recordkeeping June 2009 - FDA's new guidance
cGMP for Dietary Supplements Final Rule June 22, 2007 - FDA's Preamble and Final Rule to the Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
cGMP for Dietary Supplements 21CFR Part 111 - Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
FDA Press Release announcing cGMP for Dietary Supplements June 22, 2007 - FDA's Press Release
FDA's Background info on cGMP for Dietary Supplements June 22, 2007 - FDA's Backgrounder document
FDA Consumer article on new Safe Use of Dietary Supplements June 22, 2007 - FDA Consumer Health Information article
Definition of Adulteration- Section 402 of the Federal Food, Drug, and Cosmetics Act