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(Indianapolis, IN) Performance Validation, Inc. has acquired 100% of the interests of the Welsh Commissioning Group, Inc. (WCG) headquartered in Auburn, Washington. Structured as a 100 percent employee-owned private company, or an “S corporation employee stock ownership plan” (S ESOP), Performance Validation (PV) credits its success to its employee-owners who operate with a vested interest in […]
Read MorePart 11 Compliance Considerations for SCADA Systems
Supervisory Control and Data Acquisition (SCADA) systems are tremendous assets in the pharmaceutical, medical device, and other FDA regulated manufacturing industries, providing cost efficiencies and improving the consistency of product quality. They have also enabled the industries to move from hardcopy to electronic production records. Systems used for manufacturing pharmaceuticals, medical devices, and other regulated […]
Read MoreOut of Specification Results
What happens when a firm obtains out of specification results? 21 CFR 211.192 states: All drug product production and control records, including those for packaging and labeling, shall be reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. Any unexplained discrepancy […]
Read MoreNew Indiana PV Project Leader
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 […]
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