34th SQA Annual Meeting and Quality College

Z-1  How the Poison Squad contributed to the 1906 Pure Food and Drug Act 

Abstract:
Dr. Harvey Wiley’s concern for pure food led him to question the safety of chemical preservatives in the public food supply.  At that time, it was common to preserve meats with saltpeter, ketchup with benzoic acid, and milk with formaldehyde, just to name a few.  Starting in 1902, he formed the Poison Squad, to test the effects of some of the most commonly used food additives on human volunteers.  Young men volunteered for these trials, pledging one year of service to receive three square meals a day of intentionally poisoned food.  The information generated by these ‘human lab rats’ led, in part, to the promulgation of the 1906 law.

Category:
Other

Level of Content:
Basic

Z-2 GLP Test, Control and Reference Substance Preparation and Characterization: The Roles of the Study Director, Test Facility Management and the Quality Assurance Unit

Abstract:
Vincella Erickson, Carol Lee and Margaret Coyle-Rees, Ph.D, RQAP-GLP
Under the Final Rule of the Federal Insecticide, Fungicide and Rodenticide Act, the EPA clearly states that characterization of test, control and reference substances intended to be used in studies meant to support research and marketing permits under 40 CFR Part 160 is necessary to ensure the integrity of studies. Characterization testing is typically conducted at the production or synthesis phase and must therefore be available on or before a study is initiated. Requirements for the production or synthesis are not addressed in the regulation in the same manner as is the characterization; however, the accuracy and retention of such records to support the preparation of test, control and reference substances are critical to support the reconstruction of the study. This presentation provides a framework for good documentation practices on test, control and reference substance preparation, and the importance of such documentation for the US EPA GLP requirement of characterization. Further, the impact of the OECD GLP Draft Advisory Document 19 on the Management, Characterization and Use of Test Items will be discussed, as well as the roles and responsibilities of the Study Director, Test Facility Management and the Quality Assurance Unit.

Category:
Good Laboratory Practices - EPA

Level of Content:
Basic

Z-3  Quality Systems for Small Companies: The Struggle is Real ...  and so is the Cost of Nonquality

Abstract:
I can't take it anymore. Well, I can but I don't want to. I'm seeing a disturbing trend in my travels around the country as a quality assurance (QA)/systems consultant. It has to do with small pharma and biotech companies as well as small vendor companies that provide services to them.  It also involves QA professionals. I'm seeing small companies that: 1) have no true QA presence 2) are giving QA responsibilities to staff members who have little to no QA experience, and/or 3) have QA staff who don't have the right type of QA experience. There are several reasons for this trend including but not limited to: 1) Small companies don't often have the budget to hire a QA Director with big pharma experience or over ten years of experience that counts and 2) They love to promote from within. This presentation will explore this trend and provide specific tips and strategies small companies can use to build the robust quality system needed to successfully operate in the pharmaceutical and biotech industry.  Your product may be stellar! Your company's technical expertise may be outstanding! You may deliver fantastic clinical results! However, if your quality system is weak; if it causes issues for a sponsor company; if it introduces gaps and concerns for regulators; if clinical trials can't be reconstructed; if data quality is questionable; if patient safety suffers .... the ultimate kick in the gut will happen in your financials. That's called the cost of nonquality ... and it's real.

Category:
Other

Level of Content:
Intermediate