Training | Ken Block Consulting

Implementing organization-wide change is no easy task. Educating personnel, from company management to line operators, is a vital step in successfully bringing positive change to any organization. The consultants of Ken Block Consulting have assisted clients of all sizes throughout the world in addressing issues in all areas of quality management and regulatory compliance. We offer training and seminars in conjunction with larger projects or as educational activities to keep your company up to date in regulatory and quality matters. Whether you are a small start-up trying to navigate the often complex regulatory pathways to market, or a multinational corporation hoping to refine your quality system or diversify your product range, Ken Block Consulting has the specialists and the know-how to address your company’s unique needs.

Examples of training topics offered +

Analysis of Data
Basic 510(k) Seminar
Complaint Handling
Corrective and Preventive Action (CAPA)
Deciding When to Submit a 510(k) Application to FDA
Document and Change Control
FDA 21 CFR 820
FDA “Hot Topics”
FDA Inspections: Preparation, Management, and Response
FDA Submissions
FDA Update
Gathering Clinical Data in U.S. Using Unapproved Devices
Good Documentation Practices (GDP)
How to Market Medical Device Products in the U.S.
Internal Auditing
Investigational Device Exemption (IDE)
ISO 13485
ISO 9001
Management Review
Medical Device Reporting (MDR)
New FDA Rules
Non-Conforming (NC) Handling
Official Correspondent Duties and Responsibilities
Process Monitoring
Process Validation Advanced
Process Validation Basic
Quality Agreement
Quality System Regulation Advanced
Quality System Regulation Introduction
Record Control
Risk Information Submitted to FDA in 510(k) Applications
Risk Management
Sampling Strategies
Software Topics (IEC 62304 and FDA)
Software Validation Advanced
Software Validation Basic
Sterilization
Supplier Partnership / Controls
U.S. Agent Duties and Responsibilities