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Pharma Curriculum Development Using a Learning Management System (LMS)

Pharma Curriculum Development Using a Learning Management System (LMS)

Step-by-Step Process for Successful Sterility Failure Investigations

Step-by-Step Process for Successful Sterility Failure Investigations

Test Method Validation to Verify your Device Performance

Test Method Validation to Verify your Device Performance

Steam Sterilization Microbiology and Autoclave Performance Qualification

Steam Sterilization Microbiology and Autoclave Performance Qualification

Supplier Quality Management Simplified

Supplier Quality Management Simplified

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

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

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

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

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

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

Successful Deviation Investigations

Successful Deviation Investigations

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

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

Design History File, Device History Record, Device Master Record and Impact of Change Controls

Design History File, Device History Record, Device Master Record and Impact of Change Controls

EO Sterilization Validation / Revalidation per ISO 11135

EO Sterilization Validation / Revalidation per ISO 11135

FDA Generic Drug Application and Paragraph IV

FDA Generic Drug Application and Paragraph IV

GLP Regulations – Introduction and Strategies for Implementation

GLP Regulations – Introduction and Strategies for Implementation

HPLC Instrument Qualification and Method Validation

HPLC Instrument Qualification and Method Validation

Solving Statistical Mysteries – What does the FDA want

Solving Statistical Mysteries – What does the FDA want

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

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

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

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

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

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

HIPAA Breaches How to Reduce Human Error

HIPAA Breaches How to Reduce Human Error

Guideline to Aseptic Technique and Clean Room Behavior

Guideline to Aseptic Technique and Clean Room Behavior

FMLA Confusion Serious Health Condition

FMLA Confusion Serious Health Condition

FDA, EU and MDSAP Inspections – Getting Prepared

FDA, EU and MDSAP Inspections – Getting Prepared

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

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

Establishing and Regaining Control of Cleanroom

Establishing and Regaining Control of Cleanroom

Advertising and Promotional Material Compliance and Review Process

Advertising and Promotional Material Compliance and Review Process

Adaptive Communications – Overcoming Communication BLOCKS

Adaptive Communications – Overcoming Communication BLOCKS

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

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

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

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

Using Learning Management Systems LMS to Develop Pharma Training – Rewards and Challenges

Using Learning Management Systems LMS to Develop Pharma Training – Rewards and Challenges

US vs EU – Medical Devices Compliance and Regulatory Affairs

US vs EU – Medical Devices Compliance and Regulatory Affairs

Trial Master File TMF – Clinical Trial Systems and FDA Expectations

Trial Master File TMF – Clinical Trial Systems and FDA Expectations

Successful Change Control Management

Successful Change Control Management

Packaging and Labeling in Pharmaceutical Product Development – Best Practices

Packaging and Labeling in Pharmaceutical Product Development – Best Practices

Laboratory Safety All You Need to Know

Laboratory Safety All You Need to Know

How to Ensure Your Foreign Vendors are FDA Compliant

How to Ensure Your Foreign Vendors are FDA Compliant

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

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

Achieving Compliance Excellence through effective Training, Documentation and Management

Achieving Compliance Excellence through effective Training, Documentation and Management

Pharmaceutical Trends for Computer Systems Regulated by FDA

Pharmaceutical Trends for Computer Systems Regulated by FDA

Medical Device Classifications

Medical Device Classifications

Metrology – Statistical Analysis of Measurement Uncertainty

Metrology – Statistical Analysis of Measurement Uncertainty