30 result(s) found for "inspection readiness"
Prepare for FDA Inspection Readiness in 2025: Join Our Expert Webinar
Mastering FDA Inspection Readiness in 2025: Essential Trends and Strategies for Drug and Device Compliance Exclusive Online Webinar | February 26, 2025 | 12 PM
The Importance of Quality Agreements in CDMO Partnerships - February 3, 2025
Partnerships with Contract Development and Manufacturing Organizations (CDMOs) have become increasingly essential in the complex and highly regulated manufacturing world. These collaborations allow companies to
Important GDUFA III Changes: Revisions for ANDA Submissions - October 21, 2024
In the evolving landscape of pharmaceutical regulation, the recent GDUFA III changes introduced by the FDA promise to enhance the submission and amendment process for
Breaking down FDA’s Guidance on Delaying, Denying, Limiting, or Refusing an Inspection - September 9, 2024
The U.S. Food and Drug Administration (FDA) plays a crucial role in ensuring the safety and efficacy of drugs and devices. One of the key
New FDA Guidance on Facility Readiness for ANDA Submissions - August 26, 2024
The U.S. Food and Drug Administration (FDA) has issued new guidance detailing how it will assign goal dates for abbreviated new drug applications (ANDAs) based
Meet the Awesome Medical Device Team at Compliance Architects - August 8, 2024
At Compliance Architects LLC, we don’t just provide top-notch quality compliance solutions; we celebrate the people who make these services possible. Our team is the
Collaborations in Quality Assessments and Inspections - July 1, 2024
In a new development for global pharmaceutical regulation, the FDA and the European Medicines Agency (EMA) recently collaborated for the first time on quality assessments
Top Reasons Why FDA Inspections Often Fail - June 10, 2024
Why do good manufacturing operations have inadequate FDA inspections? FDA warning letters and 483s are rife with references to manufacturing controls and batch failures, SOPs
Mastering FDA Inspection Readiness: Key Strategies for Compliance Success - April 15, 2024
FDA inspection readiness is always a hot topic within the life sciences industry. Much attention is paid to ensuring that SOPs are in place, employees
The Costly Consequences of Adulterated Drugs: A Call for Strong Regulatory Enforcement - April 1, 2024
In today’s pharmaceutical manufacturing landscape, trust is paramount. Patients rely on drug manufacturers' integrity to provide safe and effective medications to manage complex, targeted health
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
Risky Reliance – Be Careful with FDA’s New Compliant-Manufacturing Resumption Guidance - September 16, 2020
Guidance Inartfully Mixes New and Old Expectations – Creates Confusion for Drug and Biologics Manufacturers As the COVID-19 pandemic continues, FDA continues its efforts to
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
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
FDA Strategic Quality Planning: A Risk-Based Approach for Biopharma Manufacturing Excellence
Client Business Situation https://www.youtube.com/watch?v=L35qBg2zODQ See the video of the conference presentation about this case study HERE. Like many regulated life science manufacturers, to proactively reduce risk and
Pharmaceutical Quality Metrics: Why to Be Concerned & What to Do - 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
Welcome 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
FDA Inspection Authority: Inviolate or On Shaky Ground? - July 5, 2015
I just posted a response on LinkedIn to a recent LinkedIn post by John R. Fleder (from his firm's excellent FDALawBlog) surrounding FDA inspection authority
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
New FDA Inspections Database — How Useful for FDA-Regulated Industry? - June 28, 2011
The new FDA Inspections Database is a positive step by FDA to provide further transparency for the public (and likely their Congressional representatives!) regarding enforcement
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, dietary
HACCP: Underused, Underappreciated and Exceptionally Powerful - June 4, 2010
“When everything is critical, nothing is.” Author Unknown When you think back on your career as a Quality & Compliance Executive, how many times have
Mitigating FDA Enforcement Risks: Investing in Compliance to Safeguard Shareholder Value from Non-Compliance Impact - April 28, 2010
I’m struggling to find an answer to the following question: If you were the owner of a company, how much would you spend, year over
Navigating FDA Inspection Readiness: Interesting Insights from Jack Garvey - March 20, 2010
The following transcript is taken from Business Intelligence Solutions Interview that talks about FDA Inspection Readiness. with Jack Garvey What are the biggest issues currently
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