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FDA Topics
Overview of FDA Requirements for Regulated Industries: A Technical Track
Auditing Microbiological aspects of Manufacturing in Pharmaceuticals, Medical Device and Biotechnology
Preparing for Regulatory Inspections
Clinical Trials: Three critical dimensions of Success
Establishing a Contamination Control Program for FDA Regulated Industry
Executing Mock Audits and Preparing for Regulatory Inspections
Introduction to BioPharma
Lyophilization For Biologics
Corrective & Preventive Actions CAPA
Creating and Maintaining Effective Records and Documentation
Customers in Healthcare - Challenges in Making and Selling Medical Products
Returned Product Disposition
Establishing Compliant and Effective Document Control Systems for FDA Regulated Industry
Manufacturing Topics
Project Management Foundations and Best Practices
Project Risk Management
Principles of LEAN Manufacturing
LEAN 5S
LEAN Value Stream Mapping
Advance Data Analysis
Applying Statistical Process Control
Design of Industrial Experiments: Part I Getting Started with DOE
Design of Industrial Experiments: Part II System Optimization Using
Measurement Systems Analysis
Practical Data Analysis
cGMP Clean-in-Place (CIP)
Basic SPC for Technicians & Operators
Optimizing Your Supply Chain - Best Practices for Small and Medium Enterprises
Production & Process Control
Communication Topics
Collaborative Skills for Teams
Customer Satisfaction Skills
Effective Negotiation Skills
Effective Presentation Skills
Emotional Intelligence in the Workplace
Enhancing Communication by Understanding Yourself and Others
Technical Writing & Documentation within the FDA Regulated Environment
Management Topics
Frontline Management: Leveraging the Strengths of Your Style
Integrated Commissioning & Qualification
Managing an Effective Quality System
Management of Cleanrooms in FDA Regulated Industry
Facility Operation, Maintenance Programs, and Calibration
Planning and Time Management for Supervisors
Team Building, Diversity, Innovation, and Change
Underwriting Sponsors
Copyright 2009 Oregon Bioscience Association