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Live Webinars

Pharmaceutical Compressed Air - Quality GMP Standards and Requirements
24
June
01 : 00 PM EST
60 Minutes
Roger Cowan
Roger Cowan
7 Days Left
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Validating AI Use in Quality Systems: Practical CSV and CSA Approach for FDA Inspection Readiness
26
June
01 : 00 PM EST
90 Minutes
Carolyn Troiano
Carolyn Troiano
9 Days Left
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CMO Supplier Quality Agreements - How to Comply with new FDA and EU Guidelines for Contract Drug Manufacture
23
July
01 : 00 PM EST
60 Minutes
Roger Cowan
Roger Cowan
36 Days Left
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Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements
25
August
01 : 00 PM EST
60 Minutes
Roger Cowan
Roger Cowan
69 Days Left
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HVAC and GMP Environmental Control - for Pharmaceutical Clean Rooms
23
September
01 : 00 PM EST
75 Minutes
Roger Cowan
Roger Cowan
98 Days Left
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Recorded Webinars

AI Errors May Be Impossible to Eliminate – What That Means for Its Use in the FDA
29
April
On-demand
60 Minutes
Ginette Collazo
Ginette Collazo
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GMP Environmental Monitoring for Pharmaceutical Clean Rooms
25
March
On-demand
60 Minutes
Roger Cowan
Roger Cowan
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Medical Device Risk Management, Useability and Human Error Prevention (HEP)
13
March
On-demand
90 Minutes
John E. Lincoln
John E. Lincoln
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Mastering FDA Core Medical Device Files: DHF, DMR, DHR
9
March
On-demand
90 Minutes
John E. Lincoln
John E. Lincoln
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Master Validation Plan for FDA cGMP Compliance
6
March
On-demand
90 Minutes
John E. Lincoln
John E. Lincoln
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AI in Drug Development
3
March
On-demand
90 Minutes
John E. Lincoln
John E. Lincoln
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Risk Management for AI in Medical Devices: Insights from FDA Life-cycle Management Draft Guidance
6
February
On-demand
90 Minutes
John E. Lincoln
John E. Lincoln
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How to Transition from Classic Computer System Validation (CSV) to Computer Software Assurance (CSA) – Improve Both Compliance and Efficiency
30
January
On-demand
90 Minutes
Carolyn Troiano
Carolyn Troiano
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Human Factors-Usability Studies following ISO62366, The FDA Guidance and The New FDA Draft Guidance
20
November
On-demand
60 Minutes
Edwin Waldbusser
Edwin Waldbusser
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Latest Trends in Human Error Reduction in GMP Manufacturing: Strategies for Compliance and Operational Excellence
23
October
On-demand
90 Minutes
Ginette Collazo
Ginette Collazo
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Lifecycle and Validation of Analytical Procedures FDA ICH and USP
9
October
On-demand
60 Minutes
John C. Fetzer
John C. Fetzer
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Future of AI in Regulatory and Good Manufacturing Practice (GMP) in Pharma, Biotech, and Medical Device Industries
20
May
On-demand
90 Minutes
David Lim
David Lim
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Vendor Audit Best Practices for FDA-Regulated Computer Systems in Cloud Environments and SaaS Solutions
16
May
On-demand
90 Minutes
Carolyn Troiano
Carolyn Troiano
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FDA 510(k) Submission Process: Step-by-Step Guide for Medical Device Clearance
14
May
On-demand
90 Minutes
David Lim
David Lim
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Business Process Mapping: Streamlining Management of Data/Records for a Clinical Trial from a Variety of Stakeholders and Systems
1
April
On-demand
90 Minutes
Carolyn Troiano
Carolyn Troiano
watch recording
The 6 Most Common Problems in Computer System Assurance and Validation
25
March
On-demand
120 Minutes
David Nettleton
David Nettleton
watch recording
21 CFR Part 11 Compliance with Electronic Signatures
19
March
On-demand
90 Minutes
David Nettleton
David Nettleton
watch recording
Human Factors Engineering in Medical Device Design
30
January
On-demand
90 Minutes
Charles H. Paul
Charles H. Paul
watch recording
Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA
25
November
On-demand
90 Minutes
Carolyn Troiano
Carolyn Troiano
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Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
26
September
On-demand
90 Minutes
David Nettleton
David Nettleton
watch recording
3-Hour FDA Audit Preparation Virtual Seminar
26
August
On-demand
180 Minutes
Charles H. Paul
Charles H. Paul
watch recording
Technical Writing for Medical Devices
19
August
On-demand
120 Minutes
Joy McElroy
Joy McElroy
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21 CFR Part 11, FDA Guidance for Electronic Records and Signatures Using a Computer System Regulated by FDA
12
August
On-demand
90 Minutes
Carolyn Troiano
Carolyn Troiano
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FDA Best Audit Practices – Get Ready For The Inspection That Is Coming 2024
10
July
On-demand
120 Minutes
Charles H. Paul
Charles H. Paul
watch recording
FDA Best Audit Practices – Get Ready For The Inspection That Is Coming
26
June
On-demand
120 Minutes
Charles H. Paul
Charles H. Paul
watch recording
Corrective and Preventive Action (CAPA): Our Most Important Quality Process
5
June
On-demand
90 Minutes
William A. Levinson
William A. Levinson
watch recording
Understand and Apply ISO New Climate Change Requirements
21
May
On-demand
90 Minutes
William A. Levinson
William A. Levinson
watch recording