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For Immediate Release (Indianapolis, Indiana; June 16, 2014). Performance Validation is pleased to announce that Ms. Stephanie Welte has successfully completed certification as a Certified Quality Auditor. The Certified Quality Auditor is a professional who understands the standards and principles of auditing and the auditing techniques of examining, questioning, evaluating and reporting to determine a […]
Read MoreStephanie Welte Promoted to Principal Validation Engineer
Indianapolis, IN (August 2015) Performance Validation, a nationwide leader in providing validation, commissioning, and quality services, today announced the promotion of Stephanie Welte to Principal Validation Engineer. The Principal Validation Engineer advises clients on best industry practices; defines, plans and executes project work including research, evaluation, and/or solution development to achieve customer objectives; and lead project related functions […]
Read MoreStarting Materials
Starting Materials for Drug Products: Analysis of 108 FDA Form 483’s issued to Compounding pharmacies in 2018 was performed. A textual analysis for the term non-pharmaceutical identified approximately 11% of the facilities (12) received an observation associated with the use of non-pharmaceutical products as an ingredient (starting materials) and 1 case where a non-pharmaceutical cleaning […]
Read MoreSoftware as a Medical Device (SaMD): Clinical Evaluation and Validation
So you have a Fitbit or activity tracker? How is it going – is it helping motivate you to move more, perhaps monitoring your heart rate? That is great – but is your doctor using the data to make decisions about your health? Probably not. However, this is the kind of question we begin to […]
Read MoreSmoke Studies
A review of the Form 483’s issued to the 45-registered and inspected 503B Outsourcing Facilities identifies that over 40% (n = 19) of the inspected facilities received one or more observations concerning inadequate smoke studies. Common findings of the smoke studies included studies that were not performed under dynamic conditions, studies that do not adequately reflect […]
Read MoreCurrent Inspection Trends From FDA Warning Letters
A review of warning letters posted on September 10, 2013, to the FDA website was conducted. Four of thirteen warning letters were issued by CDRH with a subject of Quality System Regulation for Medical Devices/Adulterated. Twenty-seven violations were identified at these four manufacturers. A break-down of the identified violations follows: Citation […]
Read MoreRepeated Failures
What happens when a FDA regulated company has repeated failures during inspection or when promised corrective action does not appear to be effective? In a recent warning letter, FDA identified four citations: While not numbered as an observation, the FDA also commented that the firm does not always follow their current SOPs. Finally – FDA made […]
Read MorePromoting a Validation Mindset: Overview
Among our cadre of validation engineers and specialists we offer an experienced and knowledgeable team of personnel whose area of expertise is focused on the delivery of validation services for computerized systems. With decades of combined experience in the computerized systems validation field, our team has gained an informed point of view of what constitutes […]
Read MoreWhy is Project Information so Important: How does Project Information translate to project success?
– Bruce Beck Project information is the data and documentation generated by a number of sources including engineering, vendors, automation groups, contractors and operations as well as the C&Q team over the course of the project. Accurate, complete information in the form of data, documentation and drawings is fundamentally important to not only the project […]
Read MorePerformance Validation Announces Martin Long as President and Chief Executive Officer
INDIANAPOLIS, Dec. 7, 2021 /PRNewswire/ — Performance Validation, Inc., a leading national provider of commissioning, qualification, and validation services, today announced that Martin Long has been named as President and Chief Executive Officer effective Jan 1, 2022. Dr. Van Doel, Performance Validations outgoing president will retain his role as Board Chairman, and will retire from Performance Validation in February. Long has more […]
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