Commercial Operations

ARTICLES

PRODUCTS

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

Labeling for Prescription Drugs, Biologics and Combination Products – Webinar Recording/ Transcript

$287.00
What implications does the recent Instructions for Use (IFU) guidance have on your new drug applications and biologics license applications? Alan G. Minsk, Esq. — a partner and leader of the Food & Drug Practice Team of Arnall Golden Gregory LLP — will clarify the new guidance and explain how to comply with it. View

Medical Product Off-Label Use and Marketing – Webinar Recording/Transcript

$287.00
Mark Levy, Esq. — a litigator and trial attorney who is an expert in defending companies in alleged criminal and civil violations of the False Claims Act and the Food, Drug and Cosmetic Act — is here to share his knowledge of compliance regarding off-label marketing with you. 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

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

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

Nine-Volume Title 21 CFR Set 2019

$585.00
The federal government has compiled the new 2019 CFR volumes.






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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

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

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