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John E. Lincoln

FDA’s 2025 Inspection Trends & GMP Enforcement: What Pharma Needs to Know Now

Duration: 90 Minutes
| Pharmaceutical
| All Days

Charles H. Paul

What does the future hold for drug formulation in 2026?

Duration: 90 Minutes
| Pharmaceutical
| All Days

David Nettleton

Data Integrity Simplified: 21 CFR Part 11 Compliance with Excel

Duration: 75 Minutes
| Pharmaceutical
| All Days

Carolyn Troiano

21 CFR Part 11, FDA Guidance for Electronic Records and Signatures Using a Computer System Regulated by FDA

Duration: 75 Minutes
| Pharmaceutical
| All Days

Carolyn Troiano

Strategies for Effective Risk Management in FDA IT Infrastructure Validation

Duration: 90 Minutes
| Pharmaceutical
| All Days

Carolyn Troiano

Artificial Intelligence (AI), Machine Learning, And FDA Compliance For Computer Systems And Data

Duration: 90 Minutes
| Pharmaceutical
| All Days

William A. Levinson

How To Address ISO's New Climate Change Requirements

Duration: 60 Minutes
| Pharmaceutical
| All Days

John E. Lincoln

GCP / GLP / GMP: Comparison and Understanding of 3 of the FDA's Major Regulations

Duration: 90 Minutes
| Pharmaceutical
| All Days

Roger Cowan

CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacture

Duration: 90 Minutes
| Pharmaceutical
| All Days

Carolyn Troiano

FDA’s Recent Draft Guidance Related to 21 CFR Part 11, Electronic Records/Signatures for Clinical Investigation

Duration: 90 Minutes
| Pharmaceutical
| All Days

Carolyn Troiano

Update to FDA's Draft Guidance on 21 CFR Part 11, Electronic Records/Signatures Used for Clinical Investigation

Duration: 90 Minutes
| Pharmaceutical
| All Days

Edwin Waldbusser

Human Factors/ Usability Studies following ISO62366, the FDA Guidance, and the new FDA Draft Guidance

Duration: 60 Minutes
| Pharmaceutical
| All Days

Edwin Waldbusser

FDA Regulation of Artificial Intelligence - Machine Learning

Duration: 60 Minutes
| Pharmaceutical
| All Days

Carolyn Troiano

CSV vs. CSA: Aligning the Agile Methodology to the GAMP 5 “V” Model and SDLC Methodology

Duration: 90 Minutes
| Pharmaceutical
| All Days

John E. Lincoln

Verification and Validation - Product, Equipment/Process, Software and QMS

Duration: 480 Minutes
| Pharmaceutical
| All Days

Kelly Thomas

Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products and Investigation

Duration: 120 Minutes
| Pharmaceutical
| All Days

Ginette Collazo

Decision-Making and Human Error Prevention

Duration: 90 Minutes
| Pharmaceutical
| All Days

Ginette Collazo

The Human Error Tool Box: A Practical Approach to Human Error

Duration: 90 Minutes
| Pharmaceutical
| All Days

Ginette Collazo

Supervising a Human Error Free Environment: You Can Do a Lot More Than You Think

Duration: 90 Minutes
| Pharmaceutical
| All Days

Carolyn Troiano

Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submission

Duration: 60 Minutes
| Pharmaceutical
| All Days

Kelly Thomas

Aseptic Processing Overview and Validation

Duration: 90 Minutes
| Pharmaceutical
| All Days

Ginette Collazo

How to Write SOPs (Procedures) for Human Error Reduction/ Prevention

Duration: 90 Minutes
| Pharmaceutical
| All Days

Carolyn Troiano

GAMP®5, Second Edition and Alignment with FDA’s Draft Guidance for Computer Software Assurance (CSA)

Duration: 90 Minutes
| Pharmaceutical
| All Days

John E. Lincoln

Breakthrough Devices Program Updated Final Guidance

Duration: 90 Minutes
| Pharmaceutical
| All Days

John E. Lincoln

Unlocking Success with ISO 10993-1: Biological Evaluation of Medical Devices

Duration: 90 Minutes
| Pharmaceutical
| All Days

Ginette Collazo

Human Error Reduction In GMP Manufacturing/Floor

Duration: 90 Minutes
| Pharmaceutical
| All Days

Charles H. Paul

Risk Management in the Medical Device Design Process

Duration: 90 Minutes
| Pharmaceutical
| All Days

Kelly Thomas

Analytical Method Validation and Transfer

Duration: 90 Minutes
| Pharmaceutical
| All Days

John E. Lincoln

US FDA's AI Framework for Medical Devices

Duration: 90 Minutes
| Pharmaceutical
| All Days

Pharmaceutical

FDA’s 2025 Inspection Trends & GMP Enforcement: What Pharma Needs to Know Now

What does the future hold for drug formulation in 2026?

Data Integrity Simplified: 21 CFR Part 11 Compliance with Excel

21 CFR Part 11, FDA Guidance for Electronic Records and Signatures Using a Computer System Regulated by FDA

Strategies for Effective Risk Management in FDA IT Infrastructure Validation

Artificial Intelligence (AI), Machine Learning, And FDA Compliance For Computer Systems And Data

How To Address ISO's New Climate Change Requirements

GCP / GLP / GMP: Comparison and Understanding of 3 of the FDA's Major Regulations

CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacture

FDA’s Recent Draft Guidance Related to 21 CFR Part 11, Electronic Records/Signatures for Clinical Investigation

Update to FDA's Draft Guidance on 21 CFR Part 11, Electronic Records/Signatures Used for Clinical Investigation

Human Factors/ Usability Studies following ISO62366, the FDA Guidance, and the new FDA Draft Guidance

FDA Regulation of Artificial Intelligence - Machine Learning

CSV vs. CSA: Aligning the Agile Methodology to the GAMP 5 “V” Model and SDLC Methodology

Verification and Validation - Product, Equipment/Process, Software and QMS

Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products and Investigation

Decision-Making and Human Error Prevention

The Human Error Tool Box: A Practical Approach to Human Error

Supervising a Human Error Free Environment: You Can Do a Lot More Than You Think

Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submission

Aseptic Processing Overview and Validation

How to Write SOPs (Procedures) for Human Error Reduction/ Prevention

GAMP®5, Second Edition and Alignment with FDA’s Draft Guidance for Computer Software Assurance (CSA)

Breakthrough Devices Program Updated Final Guidance

Unlocking Success with ISO 10993-1: Biological Evaluation of Medical Devices

Human Error Reduction In GMP Manufacturing/Floor

Risk Management in the Medical Device Design Process

Analytical Method Validation and Transfer

US FDA's AI Framework for Medical Devices

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