onlinecompliancepanel

This presentation covers a methodology that can be used for any oral product process...

This interactive webinar will cover several case studies in failed freeze-dried products due to poorly designed cycles, and or poorly designed...

Medical industry today is expanding at a rapid pace and producing enormous opportunities and businesses throughout...

The first document FDA auditors review during the audit of a clinical site is the Trial Master File (TMF).

Medical foods play an important role in the management of patients with special dietary restrictions and needs.

Payments made to clinical investigators participating in clinical trials need to be disclosed to CMS under the Sunshine Act provisions of the Patient Protection and Affordable Care Act of 2010, generally referred to as Obamacare.

Orphan products have unique requirements for minimum testing to establish benefit to the target patients.

Regulators consider documentation to be a critical entity. Consequently, they always audit documentation systems and it is rare to find audits where 483s for poor documentation have not been issued.

In the document "Corporate Compliance Principles", developed by the National Center for Preventive Law.

The medical device industry is characterized and mandated by compliances with government regulations. And, failure to adhere to stated stipulations lead to severe civil and legal liabilities.