Simplifying Global Compliance
Recommended Products
EU MDR Compliance: A Checklist for Meeting Manufacturing, Safety and Performance Requirements
The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
Accelerating Generic Drug Development: The FDA’s New Plan for Increasing Generic Competition
Accelerating Generic Drug Development explains the FDA’s new policy and shows how to navigate the new pathway to approval.
Editor's Picks
European Commission Clears Up Devicemaker Vigilance Obligations
The guidance includes an updated manufacturer incident report (MIR) form that will be required for devices certified under MDD in January 2020.
Spanish Regulator Cites Drugmaker for Quality Fraud
The firm had stopped recording deviations and out-of-specification results for various drug products since January.
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Real World Evidence and Data – Webinar Recording/Transcript
$287.00
Dr. Mary Jo Lamberti — associate director of sponsored research at the CSDD — and Francis Kendall — senior director at Cytel — will share critical factors you need to consider in using RWE and provide insight into the current and planned uses of RWE to support development and post-approval safety studies. View
Drug Pricing and Reimbursement – Webinar Recording/Transcript
$287.00
The drug pricing and reimbursement landscape is changing dramatically. Understanding the current policies — and proposed changes — and how to apply them to product development and commercialization plans will greatly impact the success of your products. View
Data Integrity – Webinar Recording/Transcript
$287.00
This presentation will explain high-level data integrity concepts, the definition and importance of data integrity, regulatory expectations for preventing data integrity issues, problem areas for data integrity and strategies for detecting potential data integrity issues in your operations. View
Five-Volume Drugs/Biologics Title 21 CFR Set 2019
$300.00
The federal government has compiled the new 2019 CFR volumes. View
EU-Compliant Batch Release of Medicinal Products: How to Meet the Requirements of Annex 16 of the EU…
$135.00
The report covers critical elements of the product and process flow, strategies and tools a qualified person can use to manage supply chain, import, technical agreements and delegation. View
Organizing Data and Document Archives - Webinar Recording/Transcript
$487.00
Are your documents as organized as you think they are? Can you easily put your hands on the documents FDA investigators request? Or are you searching for that needle in a haystack? View
Extractables and Leachables: 101 - Webinar Recording/Transcript
$287.00
Driven by ICH Q3D guideline compliance requirements, plus a substantial shift in metal impurity standards, the FDA now expects compliance in nearly all dosage forms; and scrutiny extends to materials such as manufacturing equipment and dosing devices. View
Perform Effective Investigations and CAPAs - Webinar Recording/Transcript
$287.00
The Corrective and Preventive Action (CAPA) process is the heart of any quality management system. And yet, year after year, CAPA violations are the most frequently observed Quality System subsystem cited by FDA regardless of the manufacturers shape or size. View
Pharmacy Compounding Regulation - Webinar Recording/Transcript
$287.00
Karla Palmer, Director, Hyman Phelps & McNamara P.C., is among the Washington FDA bar’s foremost experts on compounding. She’ll explain the 2018 Compounding Priorities Plan and shows what’s behind the accelerating enforcement. View
Secure and Accelerate Product Approvals - Webinar Recording/Transcript
$287.00
Join FDA legal experts Greg Levine, Esq. and Kelly Combs, Esq. as they clarify the advantages of qualifying for an expedited FDA approval program, what it takes to qualify and how to secure the benefits. View
Implementing a Risk-Based Cleaning and Disinfection Program - Webinar Recording/ Transcript
$287.00
Unless you are completely up to date with relevant cleaning and disinfection industry guidance documents, regulations and auditor findings… your current program may be in trouble. View
