Leading Into the Future

Executive Education (YalePharma ExecEdu)

PHARMA EXECUTIVE PROGRAM
PROGRAMS AND COURSES

 

 

 

2010 Medical Devices Course

 

  • Biostatistics for Non-Statisticians
  • Core Skills for Team Development
  • Design Control for Medical Device Professionals
  • Effective Document Management for the Pharmaceutical, Biotech & Medical Device Industries
  • Effective Quality Assurance Auditing for FDA Regulated Industries
  • European Filing & Registration Procedures
  • FDA Inspections of Clinical Data Systems
  • FDA Inspections: What To Expect And How To Prepare
  • Financial Fundamentals for Non-Financial Personnel - How Financial Issues Impact Business
  • How to Implement Risk Management Principles and Activities Within a Quality Management System
  • How to Monitor Clinical Trials for GCP Compliance
  • How to Prepare for a Systems-based Inspection – Understanding the FDA’s Risk-based Inspections Approach and Ensuring Compliance
  • Introduction to Effective Medical Writing
  • Laboratory Safety - Basics and Beyond
  • Management, Supervisory & Leadership Skills for R&D Personnel
  • Medical Devices: EU Directives, Guidance, CE Marking and ISO Standard Certifications
  • Overview Of FDA Regulatory Compliance For Medical Devices
  • Pharmaceutical Counterfeits and Intellectual Property Rights Infringement in China
  • Practical Methods for Project Management
  • Process Validation for Medical Devices
  • Quality System Regulation for the Medical Device & Biotech Industries
  • Reporting Failure Investigations and Process Deviations
  • Root Cause Analysis for CAPA
  • Selecting and Managing CRO’s
  • Software Development for Medical Device Professionals
  • Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries
  • The EU Clinical Trial Directive
  • Validation of Computer Systems
  • Writing Effective Standard Operating Procedures and Other Process Documents
  • Writing in the Regulated Environment When English Is Your Second Language

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