ASQ Poster Session

In 2023 I start my leadership cycle through the Food, Drug and Cosmetic division, starting as chair-elect. This means time to do some content creation! Here’s the first thing I have planned.

The Food, Drug, and Cosmetic Division will be hosting a poster share on February 28th from 3-5 pm in Boston, with a cocktail hour afterwards (5-6). The event is being sponsored by Veeva Systems and will be free (big shout out to Veeva!)

We are looking for individuals and companies to share a poster on the theme of “What are you proud of in your eQMS? What about your implementation or continued use stands out and that you want to share?”

If interested in presenting a poster, please complete this form.

We ask that all posters be completed by the 22nd of February so we can get them printed.

We will record the poster presentation and make them available through my.ASQ after the event. Poster presenters must sign a standard ASQ waiver (we will make it available before the event).

An event sign-up will come out in January.

The event is open to all. While I’m thinking the focus will be heavily focused to FD&C and medical device members, other quality professionals will get value.

So please present a poster! I am very excited about this sort of sharing of ideas. I want to keep experimenting with alternative ways to share information and network, and I think the old poster session is something that has renewed utility in this day-and-age. Sort of a speed conference. Easier to create a poster and can be a compact event.

EMA Publishes 2021 GCP Compliance Report

The EMA has published the Annual Report of the Good Clinical Practice (GCP) Inspectors Working Group (IWG) 2021.

Beyond wishing for an 11 month cycle of writing and approval on my annual reports, there is some valuable information there.

In 2021, three CHMP GCP inspections were conducted entirely remotely, and three inspections were conducted in a hybrid setting. A total of 286 deficiencies, comprising 24 critical, 152 major and 110 minor findings were recorded for the 27 CHMP requested inspections conducted in 2021. This represents an average of 10-11 findings per site inspected. The three top categories were: “General”, “Trial Management” and “Computer System”. An increase in findings related to computer systems (e. g. Audit Trail and Authorized Access, Computer Validation, Physical Security System and Backup) is noted compared to the last reports.

More information is available at EMA´s Good Clinical Practice Inspectors Working Group website.

Under organisation and personel we see “Delegation of tasks to inappropriate team members.” This reinforces the needs for strong cv and job descriptions, and linking to both hiring and personnel qualification.

The computer systems observations are the greatest hits of data integrity, and should be a wakeup call to any company that treats GCP and GMP computer systems differently.

Let the 2022 annual GCP training development begin. And make sure you get that training done on time!

Sunscreen is a drug

Folks often forget that in the United States the active ingredient in sun screen is a drug and needs to meet appropriate quality system requirements. This Warning Letter to Kari Gran, Inc is a case in point.

The whole warning letter is a result of a company not realizing (or thinking they can get away with not having) the need for GMP compliance.

I’m not sure I would draw broader trends around data integrity or anything else from it.

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