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Pharmaceutical

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Recorded

David Lim

Future of AI in Regulatory and Good Manufacturing Practice (GMP) in Pharma, Biotech, and Medical Device Industries

Pharmaceutical 90 Min
May 20, 2025 David Lim

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Carolyn Troiano

Vendor Audit Best Practices for FDA-Regulated Computer Systems in Cloud Environments and Using Software-as-a-Service (SaaS) Solutions

Pharmaceutical 90 Min
May 23, 2025 Carolyn Troiano

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David Lim

Mastering the FDA 510(k) Submission Process: A Practical Guide

Pharmaceutical 90 Min
May 14, 2025 To: Dec 31, 2025

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David Nettleton

Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance 2025

Pharmaceutical 90 Min
May 13, 2025 To: Dec 31, 2025

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Carolyn Troiano

Business Process Mapping: Streamlining Management of Data/Records for a Clinical Trial from a Variety of Stakeholders and Systems

Pharmaceutical 90 Min
Apr 01, 2025 To: Dec 31, 1969

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Carolyn Troiano

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

Pharmaceutical 60 Min
Mar 10, 2025 To: Dec 31, 2025

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Roger Cowan

HVAC and GMP Environmental Control - for Pharmaceutical Clean Rooms 2025

Pharmaceutical 60 Min
Mar 03, 2025 To: Dec 31, 2025

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Roger Cowan

GMP Environmental Monitoring for Pharmaceutical Clean Rooms 2024

Pharmaceutical 60 Min
Jun 14, 2024 To: Jul 15, 2024

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William A. Levinson

Corrective and Preventive Action (CAPA): Our Most Important Quality Process

Pharmaceutical 90 Min
Jun 05, 2024 To: Dec 31, 2024

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Laura A. Dixon

Medical Record Chapter- Meeting the CMS Hospital CoPs, and Access Requirements

Pharmaceutical 90 Min
Apr 22, 2024 To: Dec 31, 2024

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Roger Cowan

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

Pharmaceutical 60 Min
Apr 19, 2024 To: Dec 31, 2024

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David Nettleton

21 CFR Part 11 and Annex 11 Compliance; Specifics Needed to Eliminate 483s When Using SaaS/Cloud

Pharmaceutical 90 Min
Feb 29, 2024 To: Dec 31, 2024

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Casper E. Uldriks

FDA’s Import Requirements and 2024 Import Warning Letters

Pharmaceutical 60 Min
Feb 12, 2024 To: Dec 31, 2024

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Carolyn Troiano

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

Pharmaceutical 90 Min
Feb 09, 2024 To: Dec 31, 2024

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Pharmaceutical

Future of AI in Regulatory and Good Manufacturing Practice (GMP) in Pharma, Biotech, and Medical Device Industries

Vendor Audit Best Practices for FDA-Regulated Computer Systems in Cloud Environments and Using Software-as-a-Service (SaaS) Solutions

Mastering the FDA 510(k) Submission Process: A Practical Guide

Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance 2025

Business Process Mapping: Streamlining Management of Data/Records for a Clinical Trial from a Variety of Stakeholders and Systems

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

HVAC and GMP Environmental Control - for Pharmaceutical Clean Rooms 2025

GMP Environmental Monitoring for Pharmaceutical Clean Rooms 2024

Corrective and Preventive Action (CAPA): Our Most Important Quality Process

Medical Record Chapter- Meeting the CMS Hospital CoPs, and Access Requirements

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

21 CFR Part 11 and Annex 11 Compliance; Specifics Needed to Eliminate 483s When Using SaaS/Cloud

FDA’s Import Requirements and 2024 Import Warning Letters

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

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Pharmaceutical

Future of AI in Regulatory and Good Manufacturing Practice (GMP) in Pharma, Biotech, and Medical Device Industries

Vendor Audit Best Practices for FDA-Regulated Computer Systems in Cloud Environments and Using Software-as-a-Service (SaaS) Solutions

Mastering the FDA 510(k) Submission Process: A Practical Guide

Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance 2025

Business Process Mapping: Streamlining Management of Data/Records for a Clinical Trial from a Variety of Stakeholders and Systems

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

HVAC and GMP Environmental Control - for Pharmaceutical Clean Rooms 2025

GMP Environmental Monitoring for Pharmaceutical Clean Rooms 2024

Corrective and Preventive Action (CAPA): Our Most Important Quality Process

Medical Record Chapter- Meeting the CMS Hospital CoPs, and Access Requirements

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

21 CFR Part 11 and Annex 11 Compliance; Specifics Needed to Eliminate 483s When Using SaaS/Cloud

FDA’s Import Requirements and 2024 Import Warning Letters

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

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