February 19, 2024
Cell and gene therapies represent a new medical frontier, offering hope for treating rare, orphan, and challenging diseases. However, the journey from development to market approval for these personalized medicines is intricate and multifaceted. With this new medical frontier, it is vital that we properly navigate the future of CAR T Cell Therapy and the […]
February 12, 2024
In the realm of quality and compliance within pharmaceuticals, biopharmaceuticals, and combination products, I’ve frequently been asked about the crucial steps to pass an FDA Pre-Approval Inspection (PAI). It brings to mind Steven Covey’s timeless advice from “The 7 Habits of Highly Effective People” – “Begin with the End in Mind.” This principle aligns perfectly […]
February 5, 2024
The highly anticipated FDA Decision on the Harmonization of the Medical Device Quality System Regulations with ISO 31485-2016 has been released, marking a significant development for the industry. Here are the key highlights and insights into the Final Proposed Rule of the ISO 31485-2016 harmonization. Highlights of the Proposed Rule Two-Year Compliance Period Industry stakeholders […]
March 21, 2023
Compliance Architects is proud to be Silver Sponsor of this year’s RIC inaugural annual meeting! Our team will be attending the event March 22-23 at Covene in Arlington, VA. We can’t wait to meet you! RIC Inaugural Annual Meeting Details The REMS Industry Consortium fosters collaboration and innovation to advance patient safety, appropriate access, and […]
October 4, 2022
The following transcript is taken from a PMWS interview with Compliance Architects CEO Jack Garvey. Jack discusses the current talent trends and what he thinks the industry will need in the next 5-10 years. Watch the full interview discussing talent trends and industry need here: 2022 PMWS by Executive Platforms Talent Trends- The Crisis The […]
August 17, 2022
Attention life science quality and compliance professionals. Mark your calendars for this Thursday, August 18th at 2PM ET! Our colleague Teresa Gorecki is presenting with four other outstanding experts on the Essentials of Post-Inspection Actions: From FDA Notices to Criminal Prosecution. This program is part of FDLI’s Summer Learning Series, and will be an exceptionally important […]
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