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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
2 Day Virtual Seminar on REACH and RoHS Compliance: Protecting Revenues with Advanced Compliance
May 14-15 This 2 day seminar will go into the specifics of the REACH and RoHS regulations
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- By Kelly Eisenhardt
2024 Human Error Prevention & GMP Training Course - New
MP3 Download this training would provide tools that can be implemented and used after this event.
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- By Ginette Collazo
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
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- By Carolyn Troiano
21 CFR Part 11 and Annex 11; what you need to know to pass the new regulatory inspections
MP3 Download describes exactly what is required for compliance with Part 11
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- By David Nettleton
3 Hours Virtual Seminar on Successful Deviation Investigations
MP3 Download Duration 180 Minutes
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- By Danielle DeLucy
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
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- By Kelly Thomas
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.
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- By Danielle DeLucy
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
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- By Jose Mora
4 Hours Training Course on Medical Device Cybersecurity and FDA Compliance
This webinar will focus on cybersecurity of medical devices
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- By Carolyn Troiano
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
A Culture of Quality is a Competitive Advantage
MP3 Download This webinar will cover FDA and NB expectations for Quality Systems , Best Practices and How culture can impact quality and compliance risk in 2021
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- By Susanne Manz
Advanced Pharmacovigilance Auditing and Inspections Virtual Live Training Course
MP3 Download Pharmacovigilance Auditing Inspection course will explain how to prepare for the audit
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- By Michael Ramcharan
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
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- By Carolyn Troiano
An Advanced Course on Lean Documents, Lean Configuration, and Document Control
MP3 Download Duration 90 Minutes
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- By Jose Mora
Analytical Method Validation Under Good Laboratory Practices (GLPs)
MP3 Download Duration 60 Minutes
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- By John C. Fetzer
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).
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- By John G. Lanese
Annual Product Quality Reviews; Preparation & Reports - FDA, EU, & Canada Regulatory Requirements an
On Demand Webinar Duration 120 minutes
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- By John G. Lanese
Applying Computer System Validation To Mobile Applications
On Demand Webinar Duration 60 minutes
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- By Carolyn Troiano
Artificial Intelligence (AI) in the Food Supply Chain
On Demand Webinar Duration 60 minutes
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- By Dr. John M. Ryans
Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products 2 Day Course
MP3 Download The objective of this live, interactive WCS training seminar is to explore the role of aseptic filling to assure that manufactured product
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- By Barry A. Friedman
Aseptic Technique and Cleanroom Behavior – Avoiding Human Error
MP3 Download this course we will review how quality systems helps in defining requirements for cleanrooms
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- By Danielle DeLucy
Best Practices To Help You Pass An FDA Computer System Validation Audit
MP3 Download Duration 90 Minutes
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- By Carolyn Troiano
Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA
MP3 Download Duration 90 Minutes
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- By Carolyn Troiano
Best Practices for Deviation Training
MP3 Download -Duration 180 Minutes
- Course
- By Danielle DeLucy
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
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- By Carolyn Troiano
Building a Compliant Laboratory – From Foundation to Business Excellence
MP3 Download In this webinar speaker will define compliance, provide a translation of regulations and guidance into user requirements .
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- By David W. Husman
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
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- By John E Lincoln
CAPA: Definition, Plan and Program
MP3 Download Duration 90 Minutes
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- By Danielle DeLucy
Clinical Data Management Training
MP3 Download Duration 2 Day
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- By Elaine Eisenbeisz
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.
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- By Jeff Kasoff
Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Product
MP3 Download In this course, you will learn the practical applications for ensuring regulatory compliance as required by FDA regulations
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- By Karl M. Nobert
Computer System Validation ( CSV) 3 Day Seminar
MP3 Download 3 day CSV course will teach you how to comply with key FDA and international CSV
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- By Carolyn Troiano
Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall
MP3 Download Duration 90 Minutes
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- By Carolyn Troiano
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
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- By Carolyn Troiano
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
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- By Carolyn Troiano
Construct and Manage the Technical File and Design Dossier
On Demand Webinar Duration 60 minutes
- Course
- By David R. Dills
Continuing to Audit during a Global Pandemic – How to Optimize Effectiveness and Minimize Risk
MP3 Download Duration 60 Minutes
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- By Susanne Manz
Creating and Maintaining an Effective and Efficient Technical Training Program
MP3 Download Duration 180 Minutes
- Course
- By Ginette Collazo
Current regulatory thinking on Data Integrity in 2020
MP3 Download Duration 2 Days
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- By Carolyn Troiano
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
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- By John E Lincoln
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
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- By John E Lincoln
DHF, DMR, DHR, Technical Documentation for US FDA, ISO and EU MDR Requirements
MP3 Download / Online On Demand-Duration 180 Minutes
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- By John E Lincoln
Data Integrity Practices for the Laboratory and Beyond
MP3 Download -Duration 90 Minutes
- Course
- By Kelly Thomas
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
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- By Carolyn Troiano
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
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- By Meena Chettiar
Detailed Investigations: How to avoid an observation
MP3 Download Duration 60 Minutes
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- By Carl Patterson
Developing an Effective CAPA Management and Root Cause Analysis System
MP3 Download Duration 180 Minutes
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- By Danielle DeLucy
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
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- By John E Lincoln
Device Changes and the 510(k) -- Device Hardware and Software Requirements
MP3 Download This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k)
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- By John E Lincoln
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
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- By John E Lincoln
Drug Development: Key to Success from Concept to Commercialization
MP3 Download This 2 Day Virtual Seminar is designed to teach employees of pharmaceutical companies
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- By Karl M. Nobert
Efficient Batch Record Design & Review Training: GMP Compliance & FDA Requirements
May 07-08 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
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- By Kelly Thomas
Efficient Batch Record Review and Product Release Course
MP3 Download Duration 240 Minutes
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- By Danielle DeLucy