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Clinical Research Solutions
It is amazing to me that more C-Level Executives do not perceive their Quality Systems as a powerful vehicle to reduce costs, improve productivity, and benefit their bottom line. Rather than embrace...
Clinical Research Solutions
Following extensive marketing of Lovenox® (enoxaparin sodium), a low-molecular weight heparin, a number of biosimilar versions of enoxaparin and one ANDA-approved formulation (enoxaparin sodium,...
Clinical Research Solutions
Next week I’ll be in San Francisco conducting an ISPE training class on Risk Based Approach to GxP Process Control Systems. Attendees will include employees from a variety of regulated life cycle...
Clinical Research Solutions
Today we have the next phase of the Nine Gate Transfer Process: Gate 8 Process Validation. To review the previous steps before continuing, examine Gates 1-7 here: Gate 1: Assessment Gate 2:...
Clinical Research Solutions
How robust are your cleaning validation measures? Could your storage procedures withstand the impacts of a fire within your facility, or would such a disaster set back your production time...
Clinical Research Solutions
Unverified Design – An Example For those of us who travel routinely, one of the most sought-after treasures in the typical airport terminal is an electrical outlet. With our dependency on mobile...
Clinical Research Solutions
At the recent Pharmaceutical Compliance Congress (PCC), Zane Memeger, U.S. Attorney for the Eastern District of Pennsylvania stated that one of the key questions that a company should ask about its...
Clinical Research Solutions
For most drugs, the process of developing and obtaining FDA approval of a generic version is simple and well-defined: sponsors must only prove that their product is pharmaceutically equivalent and...
Quality & Compliance
Today, Bob Beall is back with the next gate in the Nine Gate Transfer Process. If you have missed any of the previous steps in this process, you can review them here: Gate 1: Assessment Gate 2:...