Our Services - QSG, Inc.

Training and Consulting Services

Business Management Process Mapping and Process Improvement Leadership Development and Mentoring Creating a Value-Added Continual Improvement Program Creating a Value-Added Performance Measurement Process QFD (Quality Function Deployment) Balanced Scorecard / Business Dashboard Project Management Team Building Skills Supervisor Skills	Operations Management Six Sigma Black and Green Belt Certification Lean Business Simulation DMAIC Process - Presentation Available Here Basic Lean Manufacturing Concepts 5S Training Visual Factory Management Value Stream Mapping Standard Work Documentation Creating Manufacturing Cells Implementing a KanBan Pull Systems SMED
Quality Management Executive Management Sessions Employee Awareness Internal Audit Training GR&R – Gauge Repeatability Reproducibility Problem-Solving/Corrective Action Skills Basic Statistical Concepts DOE (Design of Experiments) FMEA – Failure Modes & Effects Analysis Advanced Product Quality Planning Process Training	Quality & Environmental Management Systems ISO 9000:2008 Transition and Implementation ISO/TS-16949:2009 Transition and Implementation ISO 13485:2003 Implementation ISO 14001 Implementation AS 9100:2009 Implementation TL 9000 Implementation ISO 17025 Implementation
Medical Devices / ISO 13485: 510(k) Process for Medical Devices Auditor/Lead Auditor Training for ISO 13485 CAPA Programs for the Medical Device Industry CE Marking, EU Directives, and Guidance Documents Design Control Concepts and Implementation FDA's Quality System Inspection Technique (QSIT) Internal Auditor Training for ISO 13485 Process Validation Principles and Protocols Risk Management and Analysis for Medical Devices Sterilization of Medical Devices Understanding an ISO 13485 Quality Management System Understanding FDA's Med Dev QSR and Understanding an ISO 13485 QMS and FDA's Quality ISO 13485:2003/FDA QSR Supplier Auditing	FDA/cGMP/Regulatory Affairs Quality System Development Internal cGMP Audits GLP Audits / GCP Audits / Contract Manufacturer Audits Quality Systems Evaluation / Compliance Gap Assessments Mock FDA Audits / Compounding Pharmacy Audits Pre Approval Inspection Support / API ICH Q7A Audits ISO 9001:2000 Audits / Labeling/Packaging Audits / Supplier Audits / Surveillance Audits Validation Audits / Design of Audit Programs Dietary Supplement Compliance Audits QA Management Responsibilities / Quality Manual Development / CAPA Development/Support SOP/Procedure Development and Review Batch Record Review and Approval / Validation Review / Equipment/Utility Validation Risk Management / Change Control Program / FDA 483 Response Support / Process Validation
Management Skills Achieving Peak Organizational Performance and Productivity