Covering Standards Including: AAR M-1003, IRIS, FDA cGMP Parts 820 and 11, CPSCIA, Social/Ethics Standards
Also serving as and additional resource for Performing Internal QA System Audits Support Train New Staff, Helping you to "Catch-up" on Annual Schedules ------------------------------------------------------- AREAS WE CAN ASSIST IN MAKING A QUANTUM IMPROVEMENT IMAPCTING YOUR BUSINESS.......... Supply-Chain Support - New Supplier Orientation.... Create Orientation for your new supplier "What is needed to Support (your company)" & Develop your Supplier Scorecards -------------------------------------------------------- Meet Process Controls Required by Standards: Process Control Plans & PFMEAs Develop Production Process mini-Audit Checklists Also: Process Control Plan & FMEA Workshops & Training ----------------------------------------------------- Procedures Review and Updates Verify accuracy and writing SOPs for gaps -------------------------------------------------- Improve Complaint Analysis & Reporting Technical Staff Root Cause Analysis "methods" Training to support your compliance with QA System requirements, such as AAR, IRIS, customer standards ============================================ We are your "extra support hands" to catch-up on "to-do" lists
=========================================== Overall Technical Support Project-by-Project or Contract Arrangements
Covering USA domestic sites, as well as China, Mexico, Canada, Italy, UK =========================================== Proven Globally Recognized "Best Practices" to integrate Prevention Steps and Problem Resolving Solutions
We are an Extra Resource for your team ============================================
Richard A. Sena, 35+ Years of manufacturing experience in roles of Manufacturing Operations Manager, Both Manufacturing and Corporate QA, Manager of New Product & Process Development, New Product Startup, Complaint Investigations
============================================= Support Your business with additional support for Product Design Reviews, Supplier, Product and Manufacturing Controls Impacted by Product and Social Compliance Issues, Consumer & Customer Complaints, & Product Safety and Liability =============================
Mergers & Acquisitions Assessments
============================== 908 - 256 - 1960 Offices in Ashburn, VA (near Wash., DC) and Hong Kong and China and Flemington, NJ: ------------------------------ PO Box 2432 Flemington, NJ, 08822 USA