Videos

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
Click here For Details

Step-by-Step Process for Successful Sterility Failure Investigations

Steam Sterilization Microbiology and Autoclave Performance Qualification

Pharma Curriculum Development Using a Learning Management System (LMS)

Test Method Validation to Verify your Device Performance

3-Hour Virtual Seminar on Handling OOS Test Results and Completing Robust Investigations

3-Hour Virtual Seminar on Root Cause Analysis for CAPA Investigations

Supplier Quality Management Simplified

3-Hour Virtual Seminar on IQ, OQ, PQ in the Verification and Validation Process

Successful Deviation Investigations

EO Sterilization Validation / Revalidation per ISO 11135

Coaching for Conflict Management – How HR Can Help Employees Manage Small Conflicts on Their Own

GLP Regulations – Introduction and Strategies for Implementation

Design History File (DHF), Device History Record (DHR), Device Master Record (DMR) and Impact of Change Controls

Packaging and Labeling in Pharmaceutical Product Development – Best Practices

Laboratory Safety – All You Need to Know

4-Hour Virtual Seminar on Batch Record Review and Product Release

How to Ensure Your Foreign Vendors are FDA Compliant – Conducting Vendor Audits, Monitoring, and Using Checklists

Advertising and Promotional Material Compliance and Review Process

Regulatory and Testing Requirements of the Bacterial Endotoxin Testing (BET) or LAL Program

Successful Change Control Management

US vs EU – Medical Devices Compliance and Regulatory Affairs

Trial Master File (TMF) – Clinical Trial Systems and FDA Expectations

Writing Validation Master Plans – Best Practices for Writing a Compliant Document

HPLC Instrument Qualification and Method Validation

FDA, EU and MDSAP Inspections – Getting Prepared

Statistical Power – Understanding, Calculating, and How to Effectively Use it

FMLA Confusion – Serious Health Condition

Guideline to Aseptic Technique and Clean Room Behavior

U.S. FDA’s 510(k), IDE, and PMA Documentation, Submission and Approval Process

FDA Expectations for 505(b)(2) Regulatory Pathway for New Drugs

Multi-Generational Workplace Success – Are You Prepared for the Post-Boomer Workforce?

HIPAA Breaches – How to Reduce Human Error

Solving Statistical Mysteries – What does the FDA want

Adaptive Communications – Overcoming Communication BLOCKS

Establishing and Regaining Control of Cleanroom

Advertising and Promotional Material Compliance and Review Process