Inspections and Audits

ARTICLES

PRODUCTS

eCTD Submissions — What You Need to Know to Comply with FDA Requirements - Webinar Recording/Transcript

$287.00
Drug and biologics makers have dodged a bullet — twice — on electronic filings (eCTD) of INDs, DMFs, ANDAs, NDA, and BLAs. But the new deadline — May 5, 2019 — will be here before you know it. View

Investigations Operations Manual 2018

$377.00
Don’t wait for FDA investigators to tell you what their new focus is when they’re already at your facility. Get a heads up with Investigations Operations Manual 2018. View

Advertising & Promotion Hot Topics in Today’s FDA and FTC Landscape - Webinar Recording/ Transcript

$287.00
Drug and device advertising, marketing and promotion has come a long way from 30-second TV spots. These days the cutting edge is social media, product placement, engaging influencers, reality TV, pop-up shops and more. View

FDA’s New Concept of Operations for Drug Inspections & Evaluations - Webinar Recording/ Transcript

$287.00
ConOps is the acronym for a soon-to-take-place FDA restructuring that’s certain to affect drug inspections going forward. How will the agency’s new vertically integrated, programmatically aligned environment affect the new roles and responsibilities of CDER and ORA? View

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