PV
the practice of monitoring the effects of medical drugs after they have been licensed for use, especially in order to identify and evaluate previously unreported adverse reactions
What is Pharmacovigilence?
GMP
Are you down with Good Manufacturing Practices?
FDA warnings letters addressee
Who is the management representative (Teresa)?
Recalled for elevated lead and chromium levels
ScarAway Gel
What is a medical device?
northamericanscientificaffairs@allianceph.com
QSR
Incorrrect Labeling
What is Misbranding
True or False - Noncompliance to FDA regulations have no criminal penalties.
What is FALSE
Vamousse Treatment Mousse
What is a Homeopathic Drug?
ScarAway Gel causes a rash
What is an adverse event?
Manage change to prevent unintended consequences, maintain processes in a suitable or “validated state” and prevent any consequences from impacting the product or process quality.
What is change control?
Source of FDA Authority
What is Interstate Commerce or the food, drug and cosmetic act?
any filthy, putrid, or decomposed substance, or if it is prepared, packed, or held under unsanitary condition
What is Adulteration?
Amberen Advanced Menopause Gummy
What is a dietary supplement
Length of time to report an adverse event at Alliance?
What is one business day?
What are quality records?
Inspector at the door!
What is call quality!
Products labeled and marketed beyond the regulatory product category?
What is misbranded
CAPA
Corrective Action Preventable Action
No procedures for handling complaints.
No contact info for customers to report complaints
Serious Adverse Events not reported to FDA in 30 days
What are PV process failures?
Traceable - to the person / role
Purpose / Reason
Date / Time
What are requirements for signatures?
This document clarifies our intent "To provide safe and clinically effective products that are manufactured with rigorous requirements that exceed our customer expectations while maintaining exceptional compliance to regulatory requirements in the markets where API distributes products.
What is the quality policy?
Significant Violations of GMPS at homeopathic manufacturers
Why it is difficult to find suppliers of the active substance in Vamousse?
Medical Device