Quality

ARTICLES

Australian TGA Reports Increased Inspections in 2016

Australia’s Therapeutic Goods Administration increased first-time inspections of drug manufacturing facilities by 16 percent in the second half of 2016, compared to the same period a year earlier, according to the agency’s latest performance report. Read More

PRODUCTS

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

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

Top Ten Data Integrity Traps: How to Find and Fix Problems

$177.00
The Top Ten Data Integrity Traps report shows you where most data integrity problems occur and helps you create a plan to weed them out — and keep them out. View

Inspections — From the Routine to the Truly Bizarre - Webinar CD/Transcript

$287.00
As you are well aware, even a routine FDA inspection can be problematic — challenging — or truly bizarre. Be prepared to deal with the challenging inspection situations that an FDA inspector may throw your way. View

Managing Contract Manufacturers and Testing Labs

$397.00
Are your contract manufacturers getting you in trouble? Problems with a contract manufacturer or lab can emerge in dozens of unexpected places. From changes in personnel or equipment to faulty SOPs and training, the list can seem impossible to tame. View

Supplier Auditing: A Four-Part Plan

$177.00
You need a supplier auditing program that helps you stay on top of all your outsourced operations. The FDAnews Brief Supplier Auditing: A Four-Part Plan helps you build a system that shows the FDA and other regulators that you hold the reins when it comes to supplier quality. View

Reduce Human Error in Drug and Device Manufacturing - Webinar CD/Transcript

$287.00
What causes drug and device manufacturing failures and recalls? Human error. Time after time, CAPA investigations single it out as the root cause of violations. If there were a magic formula for ending human error, we’d share it. But here’s the next best thing — systematic best practices and strategies that have been proven to cut human error and boost success on the factory floor. View

False Claims Act Liability for Regulatory Noncompliance - Webinar CD/Transcript

$287.00
The Department of Justice’s interim final rule virtually doubles penalities for those that violate the False Claims Act. How can you avoid liability under the FCA? Join Anna Laakmann — Counsel, Greenberg Traurig — explains how regulatory noncompliance can form the basis of an FCA enforcement action by the government. View