Quality and Compliance Due Diligence in Pharmaceutical Transaction
Regulatory compliance and quality assurance must be thoroughly evaluated in the fast-paced world of pharmaceutical transactions, mergers, acquisitions, and partnerships. Due diligence plays a pivotal
PMWS 24: New Pharma Manufacturing Insights
From May 13th to 15th, Compliance Architects attended the 2024 Pharma Manufacturing World Summit. The event gathers SVPs and VPs of Manufacturing, Quality, Supply Chain,
GxP Best Practices Part 4: Regulatory Compliance Risks
In session 4 of our Executive GxP Training program, Teresa Gorecki discusses understanding and managing the regulatory compliance risks to your business. The two provide
GxP Best Practices Part 3: GMP Compliance in Outsourced Manufacturing
In session 3 of the Executive GxP Training, Teresa Gorecki and Jamie Colgin discuss how GMP compliance applies to companies that have outsourced all manufacturing
GxP Best Practices Part 1: Outsourced Operations
In this 4 part series, we are talking through GxP Best practices This article reviews the key highlights from Teresa Gorecki's Executive GxP training, Session
The Loper Bright v. Raimondo Decision: Navigating the Double-Edged Sword of Reduced Federal Regulatory Power
Based on my recent discussions with clients and industry stakeholders, the consequences of the Supreme Court's recent Loper Bright v. Raimondo decision have become significant
How To Operationalize a Quality Agreement for FDA Success
The business term "Operationalize a Quality Agreement" stems from my dual background as an attorney and an engineer, with extensive experience in contract work. Contracts
Current Talent Trends, and Industry Needs in the Next 5-10 Years
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
Essentials of Post-Inspection Actions: From FDA Notices to Criminal Prosecution | August 18, 2022 | 2:00–3:30 PM ET | Live Webinar | FDLI
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
Welcome Randy Lumia, SPHR, SHRM-SCP to Compliance Architects®
It gives us great pleasure to announce that Randy Lumia has joined us as a full-time Vice President of Human Resources & Organizational Effectiveness. As many
John (Jack) Garvey Has Been Selected by Our Partners QbDVision to Join Their Newly Formed Board of Advisors
We are excited to announce that our CEO, Jack Garvey, has been selected by our partners QbDVision to join their newly formed board of advisors!
Companies Partnering with CMOs and CDMOs: Tips on Success
The CDMO and CMO relationships and the whole kind of business dynamic is critically important to the life sciences space. And particularly now with what