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Enterprise Risk Strategy and Emerging Technologies to address critical needs

Enterprise Risk Strategy and Emerging Technologies to address critical needs

On July 31, 2019 I had the opportunity to listen into a PricewaterhouseCoopers (PwC) webinar hosted by SDRAN discussing how to build a risk strategy utilizing emerging technologies such as Artificial Intelligence, Blockchain and IOT to improve quality, strengthen compliance and controls such as adverse event controls, reporting and reduce non-conformances. As technology has advanced, the amount of data being produced by corporations is enormous and at best only a small fraction (PwC estimates .5%) is currently analyzed leaving a huge opportunity for anyone willing to invest in these emerging technologies. A more data driven focused approach can assist in accuracy, completeness and timeliness of reporting and compliance. Underlying the point of adoption of emerging technologies in large firms, PwC conducted a survey of 7,300 respondents in 123 territories with the majority of respondents being senior executives. The results showed that continuous monitoring of network and email for security is showing the greatest adoption at 40% of respondents utilizing the tech. Anomaly detection, proactive detection of threats and data...

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FDA Issues New Import Data Requirements

FDA Issues New Import Data Requirements

One of FDA’s many responsibilities is to review imported products regulated by the agency to determine admissibility. This job has become increasingly challenging with growing volumes of imports of FDA-regulated products each year — from six million import entries in 2002 to 35 million in 2015. To help meet that challenge in a way that benefits both government and the trade community, import entries of products regulated by FDA are submitted through an electronic system called the Automated Commercial Environment (ACE). A final rule published on November 29 in the Federal Register specifies certain data that must be submitted in ACE when an FDA-regulated product is offered for import into the United States. The effective date of the rule is December 29, 2016, 30 days from the date of publication. The trade community helped us pilot ACE, which is operated by U.S. Customs and Border Protection (CBP), from August 2015 to May 2016. In July 2016, ACE became the sole CBP-authorized system for electronic submissions of entries that contain...

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Compliance Dates for UDI Regulatory Requirements

Compliance Dates for UDI Regulatory Requirements

Key compliance dates in the UDI final rule. Compliance Date Requirement September 24, 2014 All Class III devicesThe labels and packages of class III medical devices and devices licensed under the Public Health Service Act (PHS Act) must bear a UDI. § 801.20.Dates on the labels of these devices must be formatted as required by § 801.18. Data for these devices must be submitted to the GUDID database. § 830.300. A 1-year extension of this compliance date may be requested under § 801.55; such a request must be submitted no later than June 23, 2014. Class III stand-alone software must provide its UDI as required by § 801.50(b). September 24, 2015 Class II Implantable, life-saving, and life-preserving DevicesThe labels and packages of implantable, life-supporting, and life-sustaining devices must bear a UDI.  § 801.20.Dates on the labels of these devices must be formatted as required by § 801.18. A device that is a life-supporting or life-sustaining device that is required to be labeled with a UDI must a bear UDI as a permanent...

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Our Core Team

Our experts are tireless and dedicated to delivering results.

Glen Feye, MS, and CQE

Glen Feye, MS, and CQE

Accurate FDA Consultants President and Founder

Dilip Ashtekar, Ph.D.

Dilip Ashtekar, Ph.D.

Barney King, MD, MBA

Executive Regulatory and Clinical Consultant

Mario Gemar, PhD.

RA/QA Consultant

Sebastian Feye, BSC

Sebastian Feye, BSC

RA Manager