FDA Topics

• Overview of FDA Requirements for Regulated Industries: A Technical Track
• Preparing for Regulatory Inspections  
• Executing Mock Audits and Preparing for Regulatory Inspections   
• Corrective & Preventive Actions CAPA
• Creating and Maintaining Effective Documentation in the FDA Regulated Environment    
• Packaging and Labeling in an FDA Regulated Environment
• Labeling, Advertising and Promotion
• Complaints, MDR & Adverse Reporting

Manufacturing Topics

• Project Risk Management
• Principles of LEAN Manufacturing 
• LEAN Value Stream Mapping
• Applying Statistical Process Control
• Design of Experiments: Part I Getting Started with DOE
• Design of Experiments: Part II System Optimization Using DOE 
• Measurement Systems Analysis  
• Optimizing Your Supply Chain - Best Practices for Small and Medium Enterprises
• Analyzing Multi-factor Data
• Contamination Control for the Bioscience Industry
• Practical Data Analysis

Communication Topics

• Customer Satisfaction Skills
• Effective Negotiation Skills
• Effective Presentation Skills
• Enhancing Communication by Understanding Yourself and Others
• Technical Writing & Documentation within the FDA Regulated Environment
• Business Writing for Professionals
• Writing Defensively to Avoid Products Liability Litigation
• Developing Warnings & Instructions to Reduce Products Liability Risks and Communicate Effectively

Management Topics

• Frontline Management: Leveraging the Strengths of Your Style
• Managing an Effective Quality System
• Planning and Time Management for Supervisors
• Project Management Foundations and Best Practices
• Engineers' Bootcamp
• Finance Skills for Non-Finance People
• Effective Problem Solving