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Indianapolis, IN (November 18, 2013) Performance Validation, a nationwide leader in providing validation, commissioning, and quality services, today announced that Derek Fraits has successfully completed his Project Leader Certification. Performance Validation’s, project leader training program is an internal program based on the PMI® body of knowledge and consists of a combination of, internal classroom training, external […]
Read MoreNew EMA Guideline
EMA released the Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container on 6 March 2019, and it will go into effect 1 October 2019. The guideline is available here. This document addresses: 4. General requirements 4.1. Requirements for the manufacture of sterile medicinal products and sterile components 4.1.1. Steam sterilisation 4.1.2. […]
Read MoreMatthew Hopson Receives ASQ-Certified Green Belt
Congratulations Matthew! Milwaukee, Wis., 06/06/2015 — The Certification Board of ASQ is pleased to announce that Matthew Hopson has completed the requirements to be named an ASQ-Certified Six Sigma Green Belt, or ASQ SSGB. As such, Matthew Hopson has reached a significant level of professional recognition, indicating a proficiency in and a comprehension of Six Sigma principles and […]
Read MoreManaging Data Integrity Risks for SCADA Systems
SCADA (Supervisory Control and Data Acquisition) software vendors have historically served industries that require tight controls over system configurations and data records. As a result, modern SCADA software systems have evolved to provide a robust set of tools intrinsically designed to prevent the intentional or unintentional undetectable alteration of system data. Most notably, the integration […]
Read MoreJuly 10 FDA Warning Letter Review
This past week two warning letters to 503B outsourcing facilities were posted to the FDA website. In one of the warning letters, the outsourcing facility compounded drugs using raw material not on the 503B bulks list, failed to include all drugs compounded in the prior 6-months, and failed to report an adverse event within the required […]
Read MoreJason LaBella – Certified Quality Auditor
For Immediate Release (Indianapolis, Indiana; January 10, 2017). Performance Validation is pleased to announce that Mr. Jason LaBella 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 MoreJacob A. Haynes Receives ASQ-Certified Quality Auditor
Milwaukee, Wis., 12/07/2013 — The Certification Board of ASQ (American Society for Quality) is pleased to announce that Jacob A. Haynes has completed the requirements to be named an ASQ-Certified Quality Auditor, or ASQ CQA. As such, Jacob A. Haynes has reached a significant level of professional recognition, indicating a proficiency in and a comprehension of auditing principles […]
Read MoreJackie Eysol – Certified Quality Auditor
For Immediate Release (Indianapolis, Indiana August 22, 2017). Performance Validation (PV) is pleased to recognize Ms. Jackie Eysol’s certification as an American Society for Quality Certified Quality Auditor (CQA). Jackie is a Senior Validation Engineer with Performance Validation. A Senior Validation Engineer is responsible for demonstrating a sound knowledge, application, and proper implementation of technical, quality […]
Read MoreFY 2016 Drug Inspection Summary
FY 2016 Drug Inspection Summary From October 1, 2015 to September 30, 2016, 691 Form 483’s were issued to Drug Manufacturers, which resulted in 3,342 individual citations. The frequency of citations ordered by subpart of 21 CFR 211 provides the following insight as to inspection trends identified by FDA for Fiscal Year 2016. As you can […]
Read MoreFY 2015 FDA Inspection Summary
FDA Inspection Trends, FY 2015 Did you know that in FY 2015 the US FDA completed 5,615 GMP inspections of registered drug and device establishments? The total number of inspections has decreased by 6.3% since FY 2013. However, the number of foreign inspections as a percent of total inspections per fiscal year have risen from […]
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