17 result(s) found for "inspection readiness"
Mastering FDA Inspection Readiness: Key Strategies for Compliance Success - April 15, 2024
Inspection readiness is always a hot topic within the life sciences industry. Much attention is paid to ensuring that SOPs are in place, employees are
Expert Tips on How To Prepare For an FDA Pre-Approval Inspection (PAI) - 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
Food and Drug Law Institute (FDLI) “Law Over Lunch” – Monday, June 29th – “Transitioning to the Future: FDA Inspections in a Post-COVID-19 – Will There Be a New Normal?”
CEO Jack Garvey will be leading Food and Drug Law Institute's "Law Over Lunch" series two weeks from today, Monday, June 29th at 11:45 am
WEBINAR: The Possibility of Virtual FDA Inspections – What You Need to Know to Be Prepared – June 26, 2020 1:00 PM ET
Join Dan Barreto, CEO at PharmQ Global Consulting, Jack Garvey, CEO at Compliance Architects, and Brian Malkin, Counsel at Arent Fox, for a video panel
Why Do FDA Inspections Often Turn Out Bad? - July 24, 2019
Why do good manufacturing operations have bad inspections? FDA warning letters and 483s are rife with references to manufacturing controls and batch failures; to SOPs
FDA Strategic Quality Planning: A Risk-Based Approach Contributing to Biopharmaceutical Manufacturing Excellence
See video of the conference presentation about this case study HERE. Client Business Situation Like many regulated life science manufacturers, in an effort to proactively reduce risk
PHARMACEUTICAL QUALITY METRICS: Why You Should Be Concerned, And What You Should Be Doing Now - November 16, 2015
FDAnews Inspections Summit I recently had the opportunity to moderate a panel discussion on pharmaceutical quality metrics at the 10th Annual FDAnews Inspections Summit in
Compliance Architects® is Gold Sponsor of FDAnews’ FDA Inspections Summit
Compliance Architects® is proud to announce that it will be the Gold Sponsor of the upcoming FDAnews FDA Inspections Summit to be held in Bethesda, Maryland (Washington, DC) on
Medical Device Warning Letter Remediation Assistance
Client Business Situation Client was a long-established manufacturer of class II durable medical devices designed for mobility assistance. Due to challenging competitive and other market
Compliance Risk Assessment and Remediation Portfolio Management Solution
Client Business Situation Client Company had experienced multiple enforcement interactions with the US Food and Drug Administration in its recent history. As a result of
AFHCAN Medical Device Data Systems (MDDS) Quality System Assessment
Client Business Situation AFHCAN (Alaska Federal Health Care Access Network), an organizational unit of the Alaska Native Tribal Health Consortium (ANTHC) is an organization dedicated to improving the
Consumer Device Inspection Readiness
Client Business Situation A leading high-volume manufacturer of consumer medical devices located outside of the United States was experiencing increased concern regarding their regulatory compliance
Organizational Announcement: Georgina (Dina) Maines, Managing Consultant
Compliance Architects® is pleased to announce that Georgina (Dina) Maines has joined our team as a Managing Consultant. Dina has more than 30 years of experience working
Jack Garvey to Moderate Panel on Pharmaceutical Quality Metrics at October FDAnews Inspections Summit
On October 23, 2014, the annual FDAnews Inspections Summit will be the forum for an exciting, informative panel focused on the FDA’s upcoming Quality Metrics program. Moderating
Webinar, June 23: Inspection Readiness for a More Aggressive FDA - June 16, 2010
Join the Center for Business Intelligence for a one-hour, information-packed webinar on managing FDA inspections from a more aggressive FDA. Now that pharmaceutical, medical device,
Interview: FDA Inspection Readiness - March 20, 2010
Business Intelligence Solutions Interview with Jack Garvey FDA INSPECTION READINESS March 2010 What are the biggest issues currently facing FDA-regulated companies when it
Audits, Assessments & Corporate Compliance Investigations - January 21, 2010
Although audits, assessments and corporate compliance investigations are not something most executives get excited about, they are critical to ensuring your FDA-regulated business is ready