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FDA Compliance Speaker

Human Factors Usability Studies Following ISO 62366 and FDA Guidance

Speaker: Edwin Waldbusser

Duration: 60 Minutes

Date: 14 Apr, 2026 (Tuesday)

FDA Compliance Speaker

The 6 Most Common Problems in FDA Software Validation and Verification

Speaker: David Nettleton

Duration: 120 Minutes

Date: 20 Apr, 2026 (Monday)

FDA Compliance Speaker

Statistical Elements of Sample Size Calculations for Non-Clinical Verification and Validation Studies

Speaker: Elaine Eisenbeisz

Duration: 90 Minutes

Date: 20 Apr, 2026 (Monday)

FDA Compliance Speaker

Excel Spreadsheets; Develop and Validate for 21 CFR Part 11 Compliance

Speaker: David Nettleton

Duration: 75 Minutes

Recorded Session

FDA Compliance Speaker

Data Integrity and Privacy - Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR in 2026

Speaker: Carolyn Troiano

Duration: 90 Minutes

Recorded Session

FDA Compliance Speaker

FDA Regulation of Artificial Intelligence/ Machine Learning

Speaker: Edwin Waldbusser

Duration: 60 Minutes

Recorded Session

FDA Compliance Speaker

FDA Compliance And Laboratory Computer System Validation

Speaker: Carolyn Troiano

Duration: 90 Minutes

Recorded Session

FDA Compliance Speaker

Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)

Speaker: Kelly Thomas

Duration: 90 Minutes

Recorded Session

FDA Compliance Speaker

FDA Recommendations for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions

Speaker: Rachelle D Souza

Duration: 75 Minutes

Recorded Session

FDA Compliance Speaker

Clinical Trial Systems: The Trial Master File (TMF) and Electronic Trial Master File (eTMF)

Speaker: Carolyn Troiano

Duration: 90 Minutes

Recorded Session

FDA Compliance Speaker

ChatGPT and Project Management: Leveraging AI for Project Management Excellence

Speaker: Charles H. Paul

Duration: 90 Minutes

Recorded Session

FDA Compliance Speaker

Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers

Speaker: Kelly Thomas

Duration: 90 Minutes

Recorded Session

FDA Compliance Speaker

Writing Effective 483 and Warning Letter Responses

Speaker: Kelly Thomas

Duration: 90 Minutes

Recorded Session

FDA Compliance Speaker

21 CFR Part 11 - Compliance for Electronic Records and Signatures

Speaker: Edwin Waldbusser

Duration: 60 Minutes

Recorded Session

FDA Compliance Speaker

2-Hour Virtual Seminar on the 6 Most Common Problems in FDA Software Validation and Verification

Speaker: David Nettleton

Duration: 120 Minutes

Recorded Session

FDA Compliance Speaker

Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR

Speaker: Carolyn Troiano

Duration: 90 Minutes

Recorded Session

FDA Compliance Speaker

How to Prepare For and Host a FDA Inspection and Respond to 483's

Speaker: Edwin Waldbusser

Duration: 60 Minutes

Recorded Session

FDA Compliance Speaker

FDA Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data Integrity

Speaker: Carolyn Troiano

Duration: 90 Minutes

Recorded Session

FDA Compliance Speaker

From Challenges to Compliance: Understanding Dietary Supplement Oversight by the FDA

Speaker: Meredith Crabtree

Duration: 90 Minutes

Recorded Session

FDA Compliance Speaker

SOPs - How to Write Them to Satisfy those Inspectors

Speaker: Meredith Crabtree

Duration: 60 Minutes

Recorded Session

FDA Compliance Speaker

Implementing an Effective Human Error Reduction Program

Speaker: Ginette M. Collazo

Duration: 90 Minutes

Recorded Session

FDA Compliance Speaker

Performance of Root Cause Analysis, CAPA, and Effectiveness Checks

Speaker: Meredith Crabtree

Duration: 90 Minutes

Recorded Session

FDA Compliance Speaker

Zero Acceptance Sampling to Reduce Inspection Costs

Speaker: William A. Levinson

Duration: 90 Minutes

Recorded Session

FDA Compliance Speaker

Setting up Quality System for FDA Regulated Products: Tips and Tricks for your Regulatory Compliance

Speaker: Meena Chettiar

Duration: 60 Minutes

Recorded Session

FDA Compliance Speaker

Ensuring Safe and Effective Pharmaceutical Products: A Comprehensive Guide to ICH Q9 (R1) Quality Risk Management in the Pharmaceutical Industry

Speaker: Meredith Crabtree

Duration: 90 Minutes

Recorded Session

FDA Compliance Speaker

Best Practices in Complaint Management for Regulatory Compliance and Customer Retention

Speaker: Jeff Kasoff

Duration: 60 Minutes

Recorded Session

FDA Compliance Speaker

Supplier Management: Overcoming Challenges and Exploring Opportunities

Speaker: Jeff Kasoff

Duration: 60 Minutes

Recorded Session

FDA Compliance Speaker

Implementing a Robust Change Control Program - Key Elements for Process and Documentation Compliance

Speaker: Kelly Thomas

Duration: 90 Minutes

Recorded Session

FDA Compliance Speaker

Aseptic Process Validation: Top-Tips for Compliance and Success

Speaker: Kelly Thomas

Duration: 90 Minutes

Recorded Session

FDA Compliance Speaker

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

Speaker: Carolyn Troiano

Duration: 60 Minutes

Recorded Session

FDA Compliance Speaker

Analytical Method Validation and Transfer Course

Speaker: Kelly Thomas

Duration: 90 Minutes

Recorded Session

FDA Compliance Speaker

FDA Compliance and Clinical Trial Computer System Validation

Speaker: Carolyn Troiano

Duration: 90 Minutes

Recorded Session

FDA Compliance Speaker

FDA current recommendations related to timely initiation of and responses to recalls

Speaker: Meredith Crabtree

Duration: 75 Minutes

Recorded Session

FDA Compliance Speaker

How to implement an effective Human Error Investigation Program

Speaker: Ginette M. Collazo

Duration: 90 Minutes

Recorded Session

FDA Compliance Speaker

Supervising a Human Error Free Environment: You can do a Lot More than you Think

Speaker: Ginette M. Collazo

Duration: 90 Minutes

Recorded Session

FDA Compliance Speaker

FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control

Speaker: Kelly Thomas

Duration: 90 Minutes

Recorded Session

FDA Compliance Speaker

Bad Standard Operating Procedures (SOPs) - Bad Training: Garbage In, Garbage Out

Speaker: Michael Esposito

Duration: 90 Minutes

Recorded Session

FDA Compliance Speaker

Data Governance for Computer Systems Regulated by FDA

Speaker: Carolyn Troiano

Duration: 60 Minutes

Recorded Session

FDA Compliance Speaker

FDA 21 CFR Part 11

Speaker: Willi Ramseier

Duration: 60 Minutes

Recorded Session

FDA Compliance Speaker

Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success

Speaker: Michael Esposito

Duration: 90 Minutes

Recorded Session

FDA Compliance Speaker

Data Governance for Computer Systems Regulated by FDA

Speaker: Carolyn Troiano

Duration: 60 Minutes

Recorded Session

FDA Compliance Speaker

FDA Case Scenarios - Best Practices for Managing Inspection Situations

Speaker: Danielle DeLucy

Duration: 60 Minutes

Recorded Session

FDA Compliance Speaker

Data Governance for Computer Systems Regulated by FDA

Speaker: Carolyn Troiano

Duration: 90 Minutes

Recorded Session

FDA Compliance Speaker

The FDA Inspection: Preparation, Performance and Follow-Up

Speaker: Jeff Kasoff

Duration: 75 Minutes

Recorded Session

FDA Compliance Speaker

FDAs Recent Clarification on Guidance for Managing Data Integrity for Regulated Computer Systems

Speaker: Carolyn Troiano

Duration: 60 Minutes

Recorded Session

FDA Compliance Speaker

Packaging and Labeling in Pharmaceutical Product Development - Best Practices

Speaker: Michael Esposito

Duration: 90 Minutes

Recorded Session

FDA Compliance Speaker

The 6 Most Common Problems in FDA Software Validation and Verification Computer System Validation Step-by-Step

Speaker: Carolyn Troiano

Duration: 90 Minutes

Recorded Session

FDA Compliance Speaker

Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices

Speaker: Susanne Manz

Duration: 90 Minutes

Recorded Session

FDA Compliance Speaker

21 CFR Part 11 Conformance for Medical Devices

Speaker: Edwin Waldbusser

Duration: 90 Minutes

Recorded Session

FDA Compliance Speaker

FDA s New Import Program for 2019

Speaker: Casper E Uldriks

Duration: 60 Minutes

Recorded Session

FDA Compliance Speaker

Using Learning Management Systems (LMS) to Develop Pharma Training: Rewards & Challenges

Speaker: Michael Esposito

Duration: 90 Minutes

Recorded Session

FDA Compliance Speaker

Manufacturing and Marketing OTC Drugs in Compliance with FDA Regulations

Speaker: Dr. Loren Gelber

Duration: 90 Minutes

Recorded Session

FDA Compliance Speaker

FDA's Enforcement Strategy for Mobile Medical Applications

Speaker: J.Lawrence Stevens

Duration: 60 Minutes

Recorded Session

FDA Compliance Speaker

Food Safety And Quality In Home Food Delivery

Speaker: Dr. John Ryan holds

Duration: 60 Minutes

Recorded Session

FDA Compliance

Human Factors Usability Studies Following ISO 62366 and FDA Guidance

The 6 Most Common Problems in FDA Software Validation and Verification

Statistical Elements of Sample Size Calculations for Non-Clinical Verification and Validation Studies

Excel Spreadsheets; Develop and Validate for 21 CFR Part 11 Compliance

Data Integrity and Privacy - Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR in 2026

FDA Regulation of Artificial Intelligence/ Machine Learning

FDA Compliance And Laboratory Computer System Validation

Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)

FDA Recommendations for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions

Clinical Trial Systems: The Trial Master File (TMF) and Electronic Trial Master File (eTMF)

ChatGPT and Project Management: Leveraging AI for Project Management Excellence

Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers

Writing Effective 483 and Warning Letter Responses

21 CFR Part 11 - Compliance for Electronic Records and Signatures

2-Hour Virtual Seminar on the 6 Most Common Problems in FDA Software Validation and Verification

Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR

How to Prepare For and Host a FDA Inspection and Respond to 483's

FDA Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data Integrity

From Challenges to Compliance: Understanding Dietary Supplement Oversight by the FDA

SOPs - How to Write Them to Satisfy those Inspectors

Implementing an Effective Human Error Reduction Program

Performance of Root Cause Analysis, CAPA, and Effectiveness Checks

Zero Acceptance Sampling to Reduce Inspection Costs

Setting up Quality System for FDA Regulated Products: Tips and Tricks for your Regulatory Compliance

Ensuring Safe and Effective Pharmaceutical Products: A Comprehensive Guide to ICH Q9 (R1) Quality Risk Management in the Pharmaceutical Industry

Best Practices in Complaint Management for Regulatory Compliance and Customer Retention

Supplier Management: Overcoming Challenges and Exploring Opportunities

Implementing a Robust Change Control Program - Key Elements for Process and Documentation Compliance

Aseptic Process Validation: Top-Tips for Compliance and Success

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

Analytical Method Validation and Transfer Course

FDA Compliance and Clinical Trial Computer System Validation

FDA current recommendations related to timely initiation of and responses to recalls

How to implement an effective Human Error Investigation Program

Supervising a Human Error Free Environment: You can do a Lot More than you Think

FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control

Bad Standard Operating Procedures (SOPs) - Bad Training: Garbage In, Garbage Out

Data Governance for Computer Systems Regulated by FDA

FDA 21 CFR Part 11

Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success

Data Governance for Computer Systems Regulated by FDA

FDA Case Scenarios - Best Practices for Managing Inspection Situations

Data Governance for Computer Systems Regulated by FDA

The FDA Inspection: Preparation, Performance and Follow-Up

FDAs Recent Clarification on Guidance for Managing Data Integrity for Regulated Computer Systems

Packaging and Labeling in Pharmaceutical Product Development - Best Practices

The 6 Most Common Problems in FDA Software Validation and Verification Computer System Validation Step-by-Step

Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices

21 CFR Part 11 Conformance for Medical Devices

FDA s New Import Program for 2019

Using Learning Management Systems (LMS) to Develop Pharma Training: Rewards & Challenges

Manufacturing and Marketing OTC Drugs in Compliance with FDA Regulations

FDA's Enforcement Strategy for Mobile Medical Applications

Food Safety And Quality In Home Food Delivery

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