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Product image for 3 Hours Virtual Seminar on Successful Deviation Investigations

3 Hours Virtual Seminar on Successful Deviation Investigations

MP3 Download Duration 180 Minutes

Course•By Danielle DeLucy

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Product image for 3 Hrs Virtual Webinar on Aseptic Processing and Validation

3 Hrs Virtual Webinar on Aseptic Processing and Validation

MP3 Download This course will provide an overview of requirements for aseptic and bulk manufacturing operations, including facility design and contamination

Course•By Kelly Thomas

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Product image for 3 Hrs Webinar on What You Need to Know: Investigating Out-of-Specification (OOS)

3 Hrs Webinar on What You Need to Know: Investigating Out-of-Specification (OOS)

MP3 Download This webinar will review the regulatory requirements for investigating an OOS Investigation.

Course•By Danielle DeLucy

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Product image for 3Hour Virtual Seminar on IEC 62304 and Demystifying Software Validation using the Principles of LDLC

3Hour Virtual Seminar on IEC 62304 and Demystifying Software Validation using the Principles of LDLC

MP3 Download This session will give you a good understanding of how the IEC 62304 differs from ISO 13485. It will also cover components of the Software

Course•By Jose Mora

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Product image for 4 Hours Training Course on Medical Device Cybersecurity and FDA Compliance

4 Hours Training Course on Medical Device Cybersecurity and FDA Compliance

This webinar will focus on cybersecurity of medical devices

Course•By Carolyn Troiano

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Product image for 6-Hour Virtual Seminar on eCTD Submissions of IND/NDA to the US FDA, EU and Canada

6-Hour Virtual Seminar on eCTD Submissions of IND/NDA to the US FDA, EU and Canada

On Demand Webinar Duration 360 minutes

Course•By Peggy J. Berry

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

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

MP3 Download This seminar will help you understand in detail the application of FDA’s 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations

Course•By Carolyn Troiano

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Product image for 21 CFR Part 11 and Annex 11; what you need to know to pass the new regulatory inspections

21 CFR Part 11 and Annex 11; what you need to know to pass the new regulatory inspections

describes exactly what is required for compliance with Part 11

Course•By David Nettleton

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Product image for 2024 Human Error Prevention & GMP Training Course - New

2024 Human Error Prevention & GMP Training Course - New

MP3 Download this training would provide tools that can be implemented and used after this event.

Course•By Ginette Collazo

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Product image for EU MDR Implementation and Transitioning to the Deadline: Essential Tasks to Complete

EU MDR Implementation and Transitioning to the Deadline: Essential Tasks to Complete

MP3 Download This 2-day virtual seminar will go into the specifics of the European Union Medical Device Regulation (EU MDR), provide case studies and share le

Course•By Kelly Thomas

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Product image for Advanced Pharmacovigilance Auditing and Inspections Virtual Live Training Course

Advanced Pharmacovigilance Auditing and Inspections Virtual Live Training Course

MP3 Download Pharmacovigilance Auditing Inspection course will explain how to prepare for the audit

Course•By Michael Ramcharan

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Product image for All About Data Integrity by Design

All About Data Integrity by Design

MP3 Download The course provides insight into the ways in which Pharma 4.0™ will serve as an enabler for next generation medicinal products and new business cases for established products

Course•By Carolyn Troiano

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Product image for An Advanced Course on Lean Documents, Lean Configuration, and Document Control

An Advanced Course on Lean Documents, Lean Configuration, and Document Control

MP3 Download Duration 90 Minutes

Course•By Jose Mora

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Product image for Analytical Method Validation Under Good Laboratory Practices (GLPs)

Analytical Method Validation Under Good Laboratory Practices (GLPs)

MP3 Download Duration 60 Minutes

Course•By John C. Fetzer

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Product image for Annual Product Quality Reviews; Preparation & Reports - FDA, EU, & Canada Regulatory Requirements

Annual Product Quality Reviews; Preparation & Reports - FDA, EU, & Canada Regulatory Requirements

MP3 Download In this live training webinar we will discuss the world-wide regulatory requirements for Annual product Reviews (or Product Quality Reviews).

Course•By John G. Lanese

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Product image for Annual Product Quality Reviews; Preparation & Reports - FDA, EU, & Canada Regulatory Requirements an

Annual Product Quality Reviews; Preparation & Reports - FDA, EU, & Canada Regulatory Requirements an

On Demand Webinar Duration 120 minutes

Course•By John G. Lanese

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Product image for Applying Computer System Validation To Mobile Applications

Applying Computer System Validation To Mobile Applications

On Demand Webinar Duration 60 minutes

Course•By Carolyn Troiano

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Product image for Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products 2 Day Course

Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products 2 Day Course

Dec 11-12 The objective of this live, interactive WCS training seminar is to explore the role of aseptic filling to assure that manufactured product

Course•By Barry A. Friedman

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Product image for Aseptic Technique and Cleanroom Behavior – Avoiding Human Error

Aseptic Technique and Cleanroom Behavior – Avoiding Human Error

MP3 Download this course we will review how quality systems helps in defining requirements for cleanrooms

Course•By Danielle DeLucy

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Product image for Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA

Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA

MP3 Download Duration 90 Minutes

Course•By Carolyn Troiano

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Product image for Best Practices for Deviation Training

Best Practices for Deviation Training

MP3 Download -Duration 180 Minutes

Course•By Danielle DeLucy

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Product image for Best Practices for Equipment Validation, Tracking, Calibration, and Preventive Maintenance

Best Practices for Equipment Validation, Tracking, Calibration, and Preventive Maintenance

MP3 Download This training will provide valuable assistance in process development include in Equipment Validation, Tracking, Calibration, and Preventive

Course•By Carolyn Troiano

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Product image for Best Practices To Help You Pass An FDA Computer System Validation Audit

Best Practices To Help You Pass An FDA Computer System Validation Audit

MP3 Download Duration 90 Minutes

Course•By Carolyn Troiano

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Product image for Biostatistics for the Non-Statistician

Biostatistics for the Non-Statistician

MP3 Download this course will have understanding of concepts and statistical methods required in pharmaceutical, biological and medical device.

Course•By Elaine Eisenbeisz

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Product image for CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations

CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations

MP3 Download Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations

Course•By John E Lincoln

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Product image for CAPA: Definition, Plan and Program

CAPA: Definition, Plan and Program

MP3 Download Duration 90 Minutes

Course•By Danielle DeLucy

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Product image for cGMP Regulatory Inspections - Through the Eyes of FDA, EMA and PMDA

cGMP Regulatory Inspections - Through the Eyes of FDA, EMA and PMDA

MP3 Download This webinar will cover the key areas of how ICH Q7 was established, it's goals and object

Course•By Kelly Thomas

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Product image for Clinical Data Management Training

Clinical Data Management Training

MP3 Download Duration 2 Day

Course•By Elaine Eisenbeisz

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Product image for Compliant Management Controls Under 21 CFR 820 and ISO 13485

Compliant Management Controls Under 21 CFR 820 and ISO 13485

MP3 Download Best QSR and ISO 13485 requirements webinar for management controls, Organizational structure and Establishment of an internal audit program.

Course•By Jeff Kasoff

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Product image for Computer System Validation ( CSV) 3 Day Seminar

Computer System Validation ( CSV) 3 Day Seminar

Dec 09 - 11 3 day CSV course will teach you how to comply with key FDA and international CSV

Course•By Carolyn Troiano

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Product image for Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall

Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall

MP3 Download Duration 90 Minutes

Course•By Carolyn Troiano

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Product image for Computer System Validation (CSV) vs. Computer Software Assurance (CSA): Following a Waterfall vs. Agile Methodology

Computer System Validation (CSV) vs. Computer Software Assurance (CSA): Following a Waterfall vs. Agile Methodology

MP3 Download The attendee will learn about FDA’s approach to modernizing technology, and how that will benefit both the Agency and industry.

Course•By Carolyn Troiano

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Product image for Computer System Validation for Cloud and COTS Applications–Live, Online Training

Computer System Validation for Cloud and COTS Applications–Live, Online Training

MP3 Download The attendee will learn about FDA’s approach to modernizing technology, and how that will benefit both the Agency and industry

Course•By Carolyn Troiano

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Product image for Computerized Systems Validation, Data Integrity & Cloud Computing In Pharma & Biotech

Computerized Systems Validation, Data Integrity & Cloud Computing In Pharma & Biotech

MP3 Download This Course will explain how to comply with key FDA and international CSV regulations

Course•By Carolyn Troiano

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Product image for Construct and Manage the Technical File and Design Dossier

Construct and Manage the Technical File and Design Dossier

On Demand Webinar Duration 60 minutes

Course•By David R. Dills

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Product image for Controlling Human Error in the manufacturing floor

Controlling Human Error in the manufacturing floor

MP3 Download This course offers practical approaches and tools to address human performance issues in GMP related environments

Course•By Ginette Collazo

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Product image for Creating and Maintaining an Effective and Efficient Technical Training Program

Creating and Maintaining an Effective and Efficient Technical Training Program

MP3 Download Duration 180 Minutes

Course•By Ginette Collazo

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Product image for Current regulatory thinking on Data Integrity in 2020

Current regulatory thinking on Data Integrity in 2020

MP3 Download Duration 2 Days

Course•By Carolyn Troiano

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Product image for Cybersecurity - The Latest US FDA Requirements

Cybersecurity - The Latest US FDA Requirements

MP3 Download This webinar will consider how cybersecurity is introduced into the CGMPs, design control (21 CFR 820.30) for devices, and post-production by update, the CAPA system, among others

Course•By John E Lincoln

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Product image for Cybersecurity, Data Integrity, Part 11, and Required Software Validation

Cybersecurity, Data Integrity, Part 11, and Required Software Validation

MP3 Download This online training describes FDA Guidances on Cybersecurity and Data Integrity , FDA’s enforcement, Software Validation , CGMPs and Cloud

Course•By John E Lincoln

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Product image for Data Integrity and Data Governance for Computer Systems Regulated by FDA

Data Integrity and Data Governance for Computer Systems Regulated by FDA

MP3 Download This webinar will help you understand in detail the application of FDA’s guidelines for Computer System Validation

Course•By Carolyn Troiano

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Product image for Data Integrity Practices for the Laboratory and Beyond

Data Integrity Practices for the Laboratory and Beyond

MP3 Download -Duration 90 Minutes

Course•By Kelly Thomas

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Product image for Dealing with CAPA- Corrective and Preventive Actions in FDA Regulated Industries

Dealing with CAPA- Corrective and Preventive Actions in FDA Regulated Industries

MP3 Download New Root Cause Analysis Techniques and CAPA Management live webinar is for those in Operations, Facilities , Engineering and QA/QC

Course•By Meena Chettiar

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Product image for Detailed Investigations: How to avoid an observation

Detailed Investigations: How to avoid an observation

MP3 Download Duration 60 Minutes

Course•By Carl Patterson

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Product image for Developing an Effective CAPA Management and Root Cause Analysis System

Developing an Effective CAPA Management and Root Cause Analysis System

MP3 Download Duration 180 Minutes

Course•By Danielle DeLucy

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Product image for Developing the Master V&V Plan to Meet U.S. FDA, ISO 13485 and 14971 Requirements

Developing the Master V&V Plan to Meet U.S. FDA, ISO 13485 and 14971 Requirements

MP3 Download In this webinar he will also discuss the consideration of the FDA’s concerns over which device functions

Course•By John E Lincoln

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Product image for Device Changes, FDA Changes, and the 510(k)

Device Changes, FDA Changes, and the 510(k)

MP3 Download In this webinar you will learn What approaches are required for product changes; for process changes

Course•By John E Lincoln

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Product image for DHF, DMR, DHR, Technical Documentation for US FDA, ISO and EU MDR Requirements

DHF, DMR, DHR, Technical Documentation for US FDA, ISO and EU MDR Requirements

MP3 Download / Online On Demand-Duration 180 Minutes

Course•By John E Lincoln

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Product image for Drug Development: Key to Success from Concept to Commercialization

Drug Development: Key to Success from Concept to Commercialization

MP3 Download This 2 Day Virtual Seminar is designed to teach employees of pharmaceutical companies

Course•By Karl M. Nobert

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Product image for Efficient Batch Record Design & Review Training: GMP Compliance & FDA Requirements

Efficient Batch Record Design & Review Training: GMP Compliance & FDA Requirements

Dec 10-11 In this accredited training, we will identify and discuss Master Batch Records (MBR), regulatory requirements, and key steps for issuance, batch record review, reconciliation, and final QA disposition

Course•By Kelly Thomas

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Product image for Efficient Batch Record Review and Product Release Course

Efficient Batch Record Review and Product Release Course

MP3 Download Duration 240 Minutes

Course•By Danielle DeLucy

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Product image for Electronic Records & Electronic Signatures; 21 CFR Part 11; Basic Concepts

Electronic Records & Electronic Signatures; 21 CFR Part 11; Basic Concepts

On Demand Webinar Duration 90 minutes

Course•By Carolyn Troiano

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Product image for Establishing a Robust Data Integrity Program

Establishing a Robust Data Integrity Program

MP3 Download This webinar will detail a data integrity governance program and principles for defining quality and data integrity into processes and systems.

Course•By Kelly Thomas

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Product image for Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)

Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)

MP3 Download This course will discuss the importance of establishing metrics, how to distinguish Key Performance Indicators (KPIs)

Course•By Kelly Thomas

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