Webinar by FDAAWARE: Reduce Compliance Risk & Vendor Risk Exposure Friday, MARCH 16th 1PM EST
WHEN: Friday, March 16, 2018 1:00 pm | Eastern Daylight Time (New York, GMT-04:00) | 1 hr.
In Today’s complex and costly compliance space, companies must leverage all information sources (structured and non-structured) to better align with the latest compliance requirements; A DEMO of new platform leveraging information of historical 483s, inspections details, recalls, warning letters and EIRs in order to reduce compliance risk
The Webinar will address the following topics:
- Leveraging information of historical 483s, inspections details, recalls, warning letters and EIRs in order to reduce compliance risk.
- Preparing companies for upcoming inspection; gathering compliance intelligence to reduce likelihood/severity of 483
- Mitigating compliance related risks, while managing: (1) LIMITED Resources (2) LIMITED Time (3) LIMITED Budget
In this Webinar we will DEMO how to analyze mine the FDA information to produce actionable recommendations to reduce risks; How to gain internal and external (third parties / suppliers) insight into compliance risks areas; Methods to leverage to leverage on key words trends; Outputs to provide your team with higher risks areas that should be prioritized and addressed; how to avoid making past mistakes and benchmark your company with othersPreparing companies for upcoming inspection; gathering compliance intelligence to reduce likelihood/severity of 483 Mitigating compliance related risks, while managing: (1) LIMITED Resources (2) LIMITED Time (3) LIMITED Budget
Giving a Boost to the Facility of the Future | Pharmaceutical Technology
Recently Presented in ISPE Conference - FDAAWARE discusses the usage of 483s and other information to assess compliance risks
Analysis of "big data" has many applications in the pharmaceutical industry, one of which is to improve risk assessment of manufacturing facilities. "Unstructured information from FDA— including 483s, inspection details, recalls, warning letters, and the CFR [Code of Federal Regulations]—can be examined to help identify compliance risk and determine what problem areas to address first, to avoid past mistakes, or to audit vendors," explained Rafi Maslaton, president at cResults Consulting, in a presentation at the ISPE event. His company has developed a platform called FDAAWARE, which creates a database of these public data and uses software to analyze and extract useful information, in conjunction with an advanced projection algorithm to assess specific sites and overall company compliance related risks.