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Step-by-Step Process for Successful Sterility Failure Investigations
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Steam Sterilization Microbiology and Autoclave Performance Qualification
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Pharma Curriculum Development Using a Learning Management System (LMS)
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Test Method Validation to Verify your Device Performance
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3-Hour Virtual Seminar on Handling OOS Test Results and Completing Robust Investigations
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3-Hour Virtual Seminar on Root Cause Analysis for CAPA Investigations
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Supplier Quality Management Simplified
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3-Hour Virtual Seminar on IQ, OQ, PQ in the Verification and Validation Process
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Successful Deviation Investigations
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EO Sterilization Validation / Revalidation per ISO 11135
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Coaching for Conflict Management – How HR Can Help Employees Manage Small Conflicts on Their Own
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GLP Regulations – Introduction and Strategies for Implementation
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Design History File (DHF), Device History Record (DHR), Device Master Record (DMR) and Impact of Change Controls
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Packaging and Labeling in Pharmaceutical Product Development – Best Practices
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Laboratory Safety – All You Need to Know
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4-Hour Virtual Seminar on Batch Record Review and Product Release
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How to Ensure Your Foreign Vendors are FDA Compliant – Conducting Vendor Audits, Monitoring, and Using Checklists
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Advertising and Promotional Material Compliance and Review Process
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Regulatory and Testing Requirements of the Bacterial Endotoxin Testing (BET) or LAL Program
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Successful Change Control Management
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US vs EU – Medical Devices Compliance and Regulatory Affairs
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Trial Master File (TMF) – Clinical Trial Systems and FDA Expectations
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Writing Validation Master Plans – Best Practices for Writing a Compliant Document
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HPLC Instrument Qualification and Method Validation
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FDA, EU and MDSAP Inspections – Getting Prepared
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Statistical Power – Understanding, Calculating, and How to Effectively Use it
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FMLA Confusion – Serious Health Condition
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Guideline to Aseptic Technique and Clean Room Behavior
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U.S. FDA’s 510(k), IDE, and PMA Documentation, Submission and Approval Process
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FDA Expectations for 505(b)(2) Regulatory Pathway for New Drugs
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Multi-Generational Workplace Success – Are You Prepared for the Post-Boomer Workforce?
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HIPAA Breaches – How to Reduce Human Error
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Solving Statistical Mysteries – What does the FDA want
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Adaptive Communications – Overcoming Communication BLOCKS
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Establishing and Regaining Control of Cleanroom
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Advertising and Promotional Material Compliance and Review Process
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