Our products are webinars and tools for lean documents and lean configuration.
We provide webinars* for applying the principles of lean documents and lean configuration:
- 3000013 Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR)
- 3000014 21 CFR Part 820 - Quality System Regulation
- 3000015 Corrective and Preventive Action (CAPA)
- 3000016 Design Inputs Design Outputs Traceability Matrix
- 3000017 Risk Management
- 3000018 An Advanced Course on Lean Documents, Lean Configuration, and Document Control
- 3000019 Controlled Document System for a Life Sciences Manufacturing Plant
- 3000020 ISO 13485:2016
- 3000022 Using Kanban JIT Systems to Run a Startup Plant
- 3000023 Supplier Quality Management
- 3000025 Software Validation
- 3000034 IEC 62304 and Demystifying Software Validation
- 3000037 Deconstructing EU MDR (3-hour webinar)
- 3000038 Supplier Quality Remediation
- 3000039 Design History File (Design History File (DHF)) Remediation
- 3000042 2-Day Virtual Seminar Supplier and Contract Manufacturer Management
- 3000043 Project Management
Other webinars in our area of expertise (not based upon lean documents and lean configuration):
- 3000021 Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device (60-minute webinar)
- 3000026 Risk Management for Medical Devices per ISO 14971 (60-minute webinar)
- 3000027 Through the Eyes of an Auditor (60-minute webinar)
- 3000028 Chipping Away at Constraints (60-minute webinar)
- 3000029 Process Validation Requirements & Compliance Strategies (60-minute webinar)
- 3000030 Effective Design of Experiments (DOE) Strategies (60-minute webinar)
- 3000031 Medical Device Software per IEC 62304 (60-minute webinar)
- 3000032 Risk-based Design Control - The New Paradigm for Medical Device Design (60-minute webinar)
- 3000033 Managing The Audit Function In A Global Company (60-minute webinar)
- 3000040 FDA Regulation of Artificial Intelligence & Machine Learning (60-minute webinar)
- 3000041 How to Conduct a Human Factors Usability Validation (60-minute webinar)
*All are 90-minute webinars unless otherwise stated