Partners for success in Quality & Compliance

Categories

Quality Control & Consultants, Entertainment Agencies & Bureaus, Translators & Interpreters

Services/Products

Training on: Basic Metrology - definitions of accuracy, precision, traceability, repeatability and reproducibility. Other topics are: International standard definitions and common measurement errors. Dimensional Measuring Systems—detailed description of various measurement and test equipment as well as the criteria for selection based on application. Measuring systems and uncertainty. Basic Geometric Dimensioning and Tolerancing ASME Y14.5 –discussion of the GD&T standard utilized on product drawings to control features related to shape, location, orientation, and run-out of a designed piece. Introduction to QSR - FDA regulation 21 CFR Part 820-introduction to the main sections of the FDA Quality system regulation and recommendations on how to implement a compliant quality system in the company. Introduction to ISO standards (ISO 9001, ISO 13485, or ISO 17025) - discussions of the ISO standard sections as they apply to the customer’s firm. Recommendations on how to implement ISO compliant systems. Managing the Calibration System—guidance on how to implement FDA/ISO compliant calibration systems. A detailed discussion of requirements includes: calibration database, identification and traceability, calibration recall, out of tolerance investigations, repair and maintenance, documentations requirements, and employee training requirements. Statistical Process Control implementation—basic statistics training to operators and inspectors for a successful implementation of an SPC program . Recommendations on software selection, programming, and maintenance as well as regular audits to ensure compliance with written procedures. . cGMP’s - 21 CFR Parts 210 & 211– requirements of FDA Good Manufacturing Practices for pharmaceutical companies. Some topics include requirements for sanitation, cleaning, garbing, documentation, etc. Lean Six Sigma Tools—Description of continuous improvement tools used to eliminate waste in manufacturing processes. Some tools discussed are Value Stream Maps, SIPOC, 5S Program, etc. Translation services (English/Spanish) - WANT Consulting offers translation services for Standard Operating Procedures and all documents related to the quality system or operational procedures. Translation services also available for various sectors such as manufacturing, banking, education, services, etc.

Payment Options

Languages

English, Spanish

Associations

ASQ CQE, ISO Lead Auditor, Lean Six Sigma Green Belt, Judge for ASQ International Team Excellence Award