Guest Commentary


guest commentaries

Guest Commentaries

This page features some knowledgeable people writing on current topics of interest. I am pretty proud of the impressive list of Guest Contributors that have graced the pages of GxP Perspectives. One of the philosophies of this blog is that a lot of the common problems facing public health and drug & device development could be solved by those of us who do the work. That’s why I want to hear from GxP professionals on areas of their expertise. If you have a topic you wish to write about, please let me know!

Our newest Guest Commentary comes from Judith Lynn in her second contribution to GxP Perspectives. This one is on:
FDA Draft Guidance on Risk-Based Monitoring, Part II

Lorraine Ellis. kicked off discussion on the August 2011 FDA Draft Guidance on Risk-Based Monitoring (Part I).

Veteran GxP Consultants Len Grunbaum and Emma Barsky wdiscuss auditing best practices:
Audit Techniques and Etiquette.

Then we have former FDAer and President of Moriah Consulting, Michael Hamrell, PhD on
Proposed User Fees for Biosimilars

Kathie Clark discusses EU & FDA cGMP Documentation Requirements for Approvals and Signatures

The SOP Doctor, Dr. Marie McKenzie Mills MICR, CSci, CBiol, MSB, a clinical scientist and trainer from the United Kingdom. on
SOP Requirements for GCPs in Europe.

Mark Stecker, the Wheelchair Kamikaze, writes on a
Patient Perspective on Medical Research

Steven Steinbreuck discusses Informed consent: New Rule on Informed Consent

Len Grunbaum and Emma Barsky from Practical Solutions discuss, GxP Quality: Building A Culture of Compliance.

Here is a topic that I know almost nothing about, by Jill Petro of Aureus Research. She discusses contracts for clinical sites. That is why it is exciting to have Guest Commentaries. I get the chance to learn!

We have the Compliance Zen himself on Upcoming FDA Guidance Documents, by John Avellanet fron Cellereun Research.

The good professor, Sid Olufs, has a recent Guest Commentary out on REACH: The European Regulation of Chemicals

TMF Reference Model: Everyone wants to know about the work Karen Reddy, co-chair of the TMF Reference workgroup for DIA, is doing. She writes about: The TMF Reference Model Explained.

Veteran GxP Consultant Len Grunbaum of Practical Solutions NJ discusses:

Part 11: How Will FDA Enforce?

Also: Building a culture of GxP Compliance

Our most popular commentary is by Barb Immel on corrective and preventive actions: CAPA Basics

The highest ratings belong to Mikki O’Neal who writes about GCP Training on Informed Consents

Here is a two-part commentary on the importance of training and education in our profession and also highly rated. In fact, the guest commentaries get higher ratings than Carl:( This Commentary was reprinted in GxP Lifeline Master Control Newsletter!

Part One of Nancie Celini’s treatise on GxP Education-

Part Two, which, logically follows part one

A special commentary from Germany by Professor Gerhard Fortwengel on a study showing Bias in Clinical Trials Sponsored by the Pharmaceutical Industry

Judith Lynn talks about managing studies and: Keeping Protocol Deviations in Check

Louise Johnson explains the ins and outs for Ten Tips for Regulatory Submissions

Louise’s second commentary is on Drug Names

Sarah Wilson continues the discussion on Protocol Adherence: Part II

Sid Olufs, our very own book reviewer, has the first Guest Commentary that the Blog posted in January on changes in FDA’s regulation of food:

FDA Has a New Look for Food

guest commentary

Your Name Here

I enjoy reading what other GxP professionals have to say. If you have a topic you would like to see the Blog discuss, by all means let me know. GxP Perspectives has a few rules: You need to know what you are talking about; You can’t say nasty things about people; and your Commentary needs to be of interest to others working in the life sciences. No pontificating or self-promotion. There are no ads on the Blog, just basic contact info. I welcome submissions between 350-650 words. I never change content so say exactly what you think. Let me know the topic and I will be happy to discuss it with you.

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Carl is solely responsible for the content of the Blog. Guest contributions are the viewpoints of the guest contributors. Please inform Carl if there are any errors that need correcting. Although this blog is commentary, I hope that the commentary is based on an accurate understanding of events. Please let me know your views.

One Response to Guest Commentary

  1. Patti Young says:

    Hello Carl:

    I just finished up an extensive review of the FDA’s 2011 investigator warning letters (total of 6)and I found the Warning Letter issued to Martin Zaiac, MD on 3/21/2011 to be an interesting case analysis.

    This PI managed to commit 5 major violations, including the inability to identify a full-term pregnancy, peripartum cardiomyopathy, pneumonia, morbid obesity and substance abuse resulting in the patient’s death. This investigator was terminated from the study, and he failed to report his site closure to the IRB until after the FDA inspection.

    I would love to hear your expert opinion on this case as it is apparent this investigator did not take heed to his signature on the Form 1572.

    I noted this investigator states on his website that he is one of the top dermatologists in Miami Beach, FL.

    My question is, what impact does a for-cause site close-out and ultimately a for-cause FDA inspection have on an MD’s private practice?

    Looking forward to your commentary on this case.

    Thank you.

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