GMPs

ARTICLES

FDA to Recognize GMP Inspections From Eight EU Countries

The FDA will begin to recognize manufacturing facility inspections conducted by drug regulatory authorities in Austria, Croatia, France, Italy, Malta, Spain, Sweden and the U.K as capable of meeting the agency’s requirements, as part of 1998 agreement between the U.S. and the European Union renegotiated earlier this year. Read More

PRODUCTS

Pharma Regulation in 2020 – Webinar Recording/Transcript

$287.00
What pharma regulatory issue will have the greatest impact on you in 2020? This presentation is your crystal ball into how the key regulatory and related issues affecting pharmaceutical quality, regulatory and compliance specialists will be addressed by the FDA in 2020. View

Increase Compliance, Reduce Risk with Integrated Digital Solutions – Webinar Recording/ Transcript

$287.00
Your connected technology — the integration of your electronic document management, training management, risk mitigation, risk management, deviation and CAPA management, and audit management systems — will trigger the kinds of checks and balances across systems that increase compliance and reduce risk. View

FDA 483s, Warning Letters & Enforcement Trends – Webinar Recording/Transcript

$287.00
How should you prepare for your next inspection? The answer, hiding in plain sight, lies in the analysis of recent FDA enforcement trends. And who better to guide you than top Washington FDA lawyers Chalana Damron Esq. and John Fuson Esq. of Crowell & Moring LLP. View

Develop World-Class SOPs that Minimize Human Error – Webinar Recording/Transcript

$287.00
Human Error Solutions’ CEO, Ginette Collazo, Ph.D. — an industrial-organizational psychologist and one of the world’s few human error reduction experts — will explain how to write and get SOPs that minimize human error. View

Using IT to Improve Data Integrity – Webinar Recording/Transcript

$287.00
Is IT a fully vested member of your data integrity team?  The success of your next inspection could depend on it. But many firms — yours among them, perhaps — haven’t fully brought the IT folks onto the team. Now comes FDAnews with an all-new webinar to help solve this problem ... before the inspectors’ next visit. View

FDA and EU Inspections – Webinar Recording/Transcript

$287.00
It’s been seven years since FDASIA was enacted and the path to globalized GMP inspections of drugmakers is complete at last. The Mutual Recognition Agreement (MRA) provides for inspection cooperation among the FDA and the 28 member nations of the EU. What happens now??? View

Drug Regulation in China - Webinar Recording/Transcript

$287.00
Do you do business in China? With the fluidity — and uncertainty — of today’s regulatory environment, you must understand exactly what China has implemented, what is pending and what the near future holds. View

Understanding the Drug Supply Chain Security Act – Webinar Recording/Transcript

$287.00
As the Drug Supply Chain Security Act’s (DSCSA) key requirements continue to take effect, FDA has begun enforcement. If you must comply with DSCSA’s implementation requirements, this presentation can’t be missed. You’ll be updated on implementation processes to gain a clear understanding of the guidelines’ nuances and tactics to avoid problem areas. View

Regenerative Medicine and Stem Cell Regulation – Webinar Recording/Transcript

$287.00
If you find the FDA’s regulatory framework regarding regenerative medicine and stem cell therapies confusing, you’re not alone. A noted expert is here to explain the current regulatory framework and FDA’s interpretation, enforcement actions not only from FDA but FTC and the states, and opportunities for the legal development and use of stem cells. 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

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