Postmarket Safety

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Investigations Operations Manual 2017

$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 2017. View

The FDA Under a New Commissioner - Webinar CD/Transcript

$287.00
Likely new FDA Commissioner Scott Gottlieb is an old agency hand thrust into a new role. Will he toe the Trump line ... or show independence? Is his past a guide ... or will he strike out in new directions? Will he ease new drug and device approvals ... or toughen them? Increase inspections ... or ease off? More 483s and warning letters ... or fewer? View

Nine-Volume Title 21 CFR Set 2017

$585.00
The federal government has compiled the new 2017 CFR volumes.






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Industry Trends and Best Practices for the Cleanroom Environment - Webinar CD/Transcript

$287.00
Cleanrooms are complicated. Product selection, rotating disinfectants, applying disinfectants and controlling bioburdens and residues are all part of the job. But what is the best way to handle it all? View

Drugmaker’s Guide to the 21st Century Cures Act: Changing the Face of Pharmaceutical and Biologics Regulation

$397.00
The Drugmaker’s Guide to the 21st Century Cures Act e-book tells you what to expect in the coming months, which new provisions are likely to cause trouble and how to get out in front of the changes. View

Five Case Studies Using the E2500 Approach to Validate Equipment, … - Webinar CD/Transcript

$287.00
The E2500 approach streamlines design qualification by focusing on design and verification of critical aspects of a manufacturing system that affect product quality and patient safety. Implementation is not easy, but worthwhile. Once implemented E2500 can effectively reduce the testing, staffing, costs and time associated with the design-qualification phase of a system’s lifecycle. View

Conducting an Internal Audit for Pharmaceutical and Medical Device Companies - Webinar CD/Transcript

$101.00
Internal audits are critical element of your quality management system. Your approach must be both systematic and documented to remain compliant. Information from an internal audit provides management with the knowledge they need to show how effectively the company maintains the quality of the product and their processes. View

The 21st Century Cures Act — Impact on Pharmaceuticals - Webinar CD/Transcript

$287.00
What do you need to know about the 21st Century Cures Act in order to thrive this year? Join legal expert Jim O’Reilly for a discussion on the biggest change in the daily activities of the drug regulatory community in five decades. View

Off-Label Drug Promotion - Webinar CD/Transcript

$287.00
The FDA allows manufacturers to engage in off-label communications under certain circumstances including: responses to unsolicited requests — through sponsorship of continuing medical education events where off-label uses are discussed — peer-reviewed journal articles — medical texts — and clinical practice guidelines containing off-label information. Join legal expert Alan Minsk — of Arnall Golden Gregory — as he discusses the FDA’s latest rules on what speech is and is not protected. View

Responding to Compounding Pharmacy Inspections - Webinar CD/Transcript

$287.00
The FDA is looking to shed light on the sometimes murky rules governing compounding operations primarily regulated on the state level, only adhering to USP 797 Pharmaceutical Compounding — Sterile Preparations. View

Inspection Intelligence: Develop a Data–Driven Approach - Webinar CD/Transcript

$287.00
To be inspection ready you must understand both the internal and external data affecting your products — and analyze and act on the data. Expert Armin Torres — Principal Software Consultant at Qualified Data Systems — discusses how to make sure that your data — which has come from multiple sources — is internally consistent across the full data set and with your company metrics and KPIs. View

20 Elements of Postmarket Reporting: Building Periodic Benefit-Risk Evaluation Reports

$177.00
With the 20 Elements of Postmarket Reporting brief you will learn how to prepare Periodic Benefit-Risk Evaluation Reports (PBRER) in a modular format that can be used in other postmarket surveillance reports required by the FDA and international regulators. View