Quality

ARTICLES

FDA Refines Quality Metrics Program Guidance

As a precursor to the FDA’s official implementation of a quality metrics reporting program, the agency will begin accepting voluntary data submissions from drugmakers on the quality of their finished dosage form drugs and APIs in early 2018 for a pilot run of the risk-based system. Read More

PRODUCTS

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

Training Staff to Detect Data Integrity Issues - Webinar CD/Transcript

$287.00
Over the past few years, global regulators have increased their focus on data integrity systems. Who is responsible for data integrity? Find out in this 90-minute presentation. View

Managing Process Validation: A Drugmaker’s Guide

$397.00
Few things in drugmaking are as challenging as process validation — nor as likely to trip you up with FDA inspectors. Hundreds of individual manufacturing processes to validate. And the most common mistakes occur after the work of validation has taken place: when documenting the work to show that it’s been done. View

24 Elements of a Successful Supplier Quality Agreement

$177.00
Do you want the confidence that you have your suppliers under control? Would you like the ability to craft a supplier quality agreement that covers all bases? How about a model for a quality agreement the FDA will approve? View

Spreadsheet Validation 2016 - Webinar CD/Transcript

$287.00
What if you could perch on the shoulder of an expert on spreadsheet validation ... look on in real time as he highlights potential pitfalls and defines innovative validation approaches ... ask why he does this instead of that ... and get feedback? View