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Videos


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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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