Simplifying Global Compliance
Recommended Products
GMP Inspection Preparation Checklist: A Tool for Internal Auditing
This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.
Biological Risk Evaluation and Management for Medical Devices
Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
Editor's Picks
Lumendi Receives 510(k) Clearance for Endoscopic Accessory
The device also assists with optical visualization, endoscopic treatment and diagnosis, and has two balloons that create a stabilizing therapeutic zone inside the colon.
HHS Issues Grants Totaling $485 Million to Fight Opioid Crisis
The Substance Abuse and Mental Health Services Administration is expected to issue a further $1 billion in grant funding in September.
Inspections and Audits
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Top Tips for Dealing with the FDA - Webinar Recording/Transcript
$287.00
The FDA is an inescapable presence in your life. It can be supportive and helpful one day, then turn on a dime and make life quite difficult indeed. But you have a say in the matter. You can control this all-important relationship to your advantage. View
Online Pharmacies — Impact on Regulatory & Quality - Webinar Recording/Transcript
$287.00
Websites selling junk drugs threaten the entire ethical drug business — manufacturers, suppliers, shippers, vendors, caregivers and patients too. It’s up to you to defend yourself. But how? View
FDA Inspection Intelligence - Webinar Recording/Transcript
$287.00
Drug and biologics makers are facing increased scrutiny of data integrity as an energized FDA deploys new tools to empower inspectors and concerns rise over Forms 483 and warning letters. View
Lean Management to Improve Quality & Compliance - Webinar CD/Transcript
$287.00
“Lean management” has come to the drug and device world, improving quality, ensuring compliance and boosting profits for those who adapt its ways to the production floor. If you’re not among them yet, then listen up. View
Compliance Confidence: Strategies for a Successful Regulatory Inspection
$595.00
Order the Compliance Confidence DVD learning set and learn strategies on how to prepare for, manage and respond to the inspection process. View
Managing FDA GCP/Bioresearch Monitoring Inspections - Webinar Recording/Transcript
$287.00
Clinical trial principal investigators and sponsors have their very own dedicated team of FDA inspectors, the Bioresearch Monitoring (BIMO) program staff. Washington public policy lawyer, David Rosen, has made a study of their inspection practices. View
Must-Know Contracting for Non-Lawyers - Webinar Recording/Transcript
$287.00
When it comes to supply contracts, it’s far better to do things right going in ... rather than pay the price down the road. In just 90 fast-moving minutes, Courtney Young Esq. of MedMarc Insurance Group walks you through the essentials of supply contracts — what to include, what to (safely) leave out, how to stand up for yourself. View
Supplier Assessment Checklists: A Tool for Vetting Vendors and Contractors
$197.00
Report includes two checklists that guide you through the process so that you don’t have to worry about missing any points or asking the wrong questions. View
The FDA Under Gottlieb-Trump and a Look Ahead - Webinar Recording/Transcript
$287.00
In Part IV of FDAnews’s Expert Insight Series, our panelists look overseas to evaluate drug and device regulation globally, and venture educated guesses concerning the direction of drug and device regulation in 2018 and beyond. View
Pharmaceutical Regulation Under Gottlieb-Trump - Webinar Recording/Transcript
$287.00
In Part III of FDAnews’s Expert Insight Series, our panel takes up drug regulation, policy and enforcement. View
Device Regulation Under Gottlieb & Trump - Webinar Recording/Transcript
$287.00
In Part II of FDAnews’s Expert Insight Series, our panel dives deep into device regulation, policy and enforcement. View
What We’ve Learned Since Scott Gottlieb Was Confirmed - Webinar Recording/Transcript
$287.00
FDAnews has assembled a standout panel — five top experts, four of them ex-FDAers — to bring their insights to bear on how the Gottlieb FDA will impact your products and programs. View