Articles by David Markovitz
Personal Productivity
FDA Resources
Timely Resource Articles
cGMP for Dietary Supplements
 

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

 

 

Articles authored by David Markovitz  to top

NEW!
Three Key Considerations in Developing Written Procedures That Work - This article describes three critical gaps to identify and overcome in developing effective written procedures

NEW!
Good Written Procedures = Compliance - This article describes how to prepare effective written procedures and get everyone to follow them

NEW!
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.

NEW!
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.


 

Personal Productivity  to top

PDF  Why Do So Many Managers Forget They're Human Beings? - Short article on effective management

PDF  Your New Hires Won't Succeed Unless You Onboard Them Properly - Short article on bring new hires on board

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."


 

FDA Resources  to top
Most recent are at the top

PDF  FDA's Statement on Strengthening the regulation of Dietary Supplements - Read this statement by Scott Gottlieb, MD, FDA Commissioner February 2019

PDF  FDA's New Efforts to Advance Biotechnology Innovation - Read this article by Scott Gottlieb, MD, FDA Commissioner June 2018

PDF  Is It Really 'FDA Approved?' - Read this article by FDA on what is approved and the FDA approval process

PDF  FDA proposes new, risk-based enforcement priorities to protect consumers from potentially harmful, unproven homeopathic drugs December 2017 - Read this Press Release with details

PDF  FDA Takes Steps to Build a Stronger Workforce November 2017 - Read this article by Scott Gottlieb, MD, FDA Commissioner

PDF  FDA Promotes Continuous Manufacturing September 2017 - Read this article by Michael Kopcha, FDA Director Office of Pharmaceutical Quality

PDF  FDA's plan to engage the public in the agency's new effort to strengthen and modernize FDA's regulatory framework September 2017 - Read this article by FDA's Deputy Commissioner for Policy, Planning, Legislation, and Analysis

PDF  New Steps to Strengthen FDA's Inspection and Oversight of Drug Manufacturing August 2017 - Read this article by Scott Gottlieb, MD, FDA Commissioner

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 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

 

 


 

Timely Resource Articles  to top
Most recent are at top

PDF Ipca Laboratories Limited FDA 483 Observation Report August 2019
Read this FDA 483 Observation Report with essentially a breakdown in the Quality Control function

PDF AveXis, Inc. FDA 483 Observation Report August 2019
Read this FDA 483 Observation Report with serious lab issues

PDF Strides Pharma Science Limited receives Warning Letter July 2019
Read this Warning Letter with numerous serious violations of GMP

PDF Deb USA Inc receives Warning Letter June 2019
Read this Warning Letter citing a breakdown of the Quality Control function

PDF Torrent Pharmaceuticals Limited FDA 483 Observation Report April 2019
Read this 17-page FDA 483 Observation Report with significant violations of cGMP

PDF Nutra Pharma Corp receives Warning Letter March 2019
Read FDA's Press Release with details

PDF USPlabs Ceases Operations in Plea Agreement March 2019
Read an article with details

PDF Ranier's Rx Laboratory Inc. Consent Decree February 2019
Read FDA's Press Release announcing a Consent Decree against this company

PDF Actavis Laboratories FL, Inc.  Warning Letter February 2019
Read this seven page Warning Letter with significant violations of cGMP

PDF Lupin Ltd. FDA 483 Observation Report January 2019
Read this twenty-page FDA 483 Observation Report with significant violations of cGMP

PDF Samson Pharmaceuticals Inc. receives Warning Letter December 2018
Read this Warning Letter witn numerous contamination issues

PDF Pharmedium Services, LLC FDA 483 Observation Report April 2018
Read this FDA 483 Observation Report with significant violations of cGMP related to Out of Specification investigations

PDF Lijiang Yanghua Biochemical and Pharmaceutical Co., Ltd. Warning Letter April 2018
Read this Warning Letter with significant violations of cGMP related to Data Integrity

PDF Dr. Scott Gottlieb is making Progress at FDA April 2018
Read this article about the current FDA Commissioner's accomplishments and goals at FDA

PDF Cantrell Drug Company FDA 483 Observation Report March 2018
Read this FDA 483 Observation Report with significant violations of cGMP

PDF Cantrell Drug Company ordered by FDA and courts to cease manufacturing and distribution March 2018
Read FDA's Press Release with details

PDF Malladi Drugs & Pharmaceuticals Limited Warning Letter March 2018
Read this Warning Letter with significant violations of cGMP issued to an API manufacturer in India

PDF Dr. Scott Gottlieb's Leadership at FDA February 2018
Read this article about the current FDA Commissioner's tenure at FDA

PDF C. O. Truxton, Inc. Warning Letter December 2017
Read this Warning Letter with significant violations of cGMP issued to a repackager of drug products

PDF Prosana Distibuciones S.A. de C.V. Warning Letter December 2017
Read this comprehensive Warning Letter with several issues and a recommendation to hire a consultant

PDF Bayer AG Warning Letter November 2017
Read this six-page Warning Letter with significant violations of cGMP issued to a company in Germany

PDF  New England Compounding Center Pharmacist convicted - faces prison October 2017 - Read FDA's Press Release

PDF Magellan Diagnostics, Inc. Warning Letter October 2017
Read this eleven-page Warning Letter with several issues following an extensive FDA 483 Observation Report issued in June 2017

PDF Magellan Diagnostics, Inc. FDA 483 Observation Report June 2017
Read this Observation Report issued to this Massachusetts medical device firm

PDF Flawless Beauty LLC (New Jersey company) gets Consent Decree after U.S. Marshals seized products September 2017
Read FDA's Press Release with details

PDF New England Compounding Center executive goes on trial for murder in meningitis contamination case September 2017
Read this article about the continuing saga of the New England Compounding Center

PDF Quality Control Meltdown at Meridian Medical Technologies September 2017
Read this article about the manufacturer of EpiPen with serious problems and patient deaths

PDF Homeolab USA Inc. Warning Letter August 2017
Read this Warning Letter issued to this drug manufacturer where they prevented FDA from taking photographs

PDF Bicooya Cosmetics Ltd Warning Letter August 2017
Read this Warning Letter issued to this drug manufacturer with major contamination issues

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 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 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 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 New England Compounding Center owners and employees arrested and charged with killing 64 people Dec 2014
Read this disturbing news account

PDF Prison time for GMP violators Sept 2014
Read this article regarding the Peanut Corporation of America salmonella contamination case and trial

 


 

cGMP for Dietary Supplements  to top

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