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
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- By Kelly Thomas
2 Day Virtual Seminar on FDA Inspection Essentials in 2022
MP3 Download This seminar, you will learn how to properly alert key members that an investigator has arrived, the proper protocol
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- By Danielle DeLucy
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
2024 Toxic Substance Control act (TSCA) Basics
MP3 Download This is a one (1) day training course on the Toxic Substance Control Act and the latest developments for 2023
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- By Kelly Eisenhardt
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
MP3 Download This webinar will cover the key aspects of complying with 21 CFR Part 11 in both validating systems and maintaining them in a validated state throughout their entire life cycle.
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- By Carolyn Troiano
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 - Compliance for Electronic Records and Signatures
MP3 Download This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security
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- By Edwin Waldbusser
21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
MP3 Download The attendee will learn a simple way to address both data integrity and Part 11 aspects of the system, focusing on risk and critical thinking
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- By Carolyn Troiano
21 CFR Part 11 Compliance for SaaS/Cloud Application
Aug 06-07 This course benefits anyone that uses computer systems to perform their job functions and is ideal for professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors
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- By David Nettleton
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 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
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
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
- Course
- By Jose Mora
Analytical Methods Validation for FDA Compliance
June 03-05 In this course, general guideline for the determination of the analytical
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- By Kelly Thomas
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
Audit Trails - Critical to Support FDA 21 CFR Part 11 and Data Integrity Compliance
MP3 Download You’ll learn an approach to both 21 CFR Part 11 and data integrity compliance understanding what FDA expects stakeholders in industry to do. There a few simple suggestions that can streamline validation activities related to all of these key areas.
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- By Carolyn Troiano
Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach
Aug 26-28 This eight-hour vendor qualification audit training will help you improve
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- By Kelly Thomas
Avoid Warning Letters in View of the U.S. FDA's Stated Goal
MP3 Download FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies.
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- By John E Lincoln
Basic GMP Training for the QC Laboratory
MP3 Download This course will provide participants with an understanding of how to effectively handle out-of-specification
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- By Kelly Thomas
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
- Course
- By Carolyn Troiano
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
Biostatistics for the Non-Statistician
May 19-20 this course will have understanding of concepts and statistical methods required in pharmaceutical, biological and medical device.
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- By Elaine Eisenbeisz
Building GMP Excellence: A Guide to Implementing Compliant Training Programs
MP3 Download The session discussed GMP regulations, agency expectations, training program responsibilities, new employee requirements, transferred employees, external service providers, events, skills qualification program, assessment, retraining, instructor qualifications, curriculum, documentation, and performance deviations.
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- By Ginette Collazo
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
- Course
- By John E Lincoln
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
- Course
- By Carolyn Troiano
Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software
MP3 Download This webinar will include a comparison of the Agile and Waterfall methodologies, along with the pros and cons of each
- Course
- 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
Conducting Successful Quality Audits: Best Practices for Managing Inspection Situations
Jan 30 In this 90-minute accredited training, you will learn the importance of having a good
- Course
- By Danielle DeLucy
Continuing to Audit during a Global Pandemic – How to Optimize Effectiveness and Minimize Risk
MP3 Download Duration 60 Minutes
- Course
- By Susanne Manz
Corrective and Preventive Action (CAPA) - Principles of Lean Documents and Lean Configuration
MP3 Download This webinar presents a fresh new approach based upon solid principles and proven practices
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- By Jose Mora
Creating and Maintaining an Effective and Efficient Technical Training Program
MP3 Download Duration 180 Minutes
- Course
- By Ginette Collazo
Current Trends in FDA Compliance and Enforcement for Regulated Computer Systems and Data
MP3 Download This webinar will focus on the key areas that are most important, including security and data integrity. Implementing and following the System Development Life Cycle (SDLC) methodology
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- By Carolyn Troiano
Current regulatory thinking on Data Integrity in 2020
MP3 Download Duration 2 Days
- Course
- 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
- Course
- 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 This Webinar will discuss the latest U.S. FDA and European Union requirements on Design History File, and Technical File/Design Dossier
- Course
- By John E Lincoln
Data Integrity -- US FDA Requirements
MP3 Download This webinar will focus on the key issues raised by the FDA, not just for products
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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
Dealing with Out of Specification Test Results in FDA Regulated Industries
MP3 Download This webinar with a thorough knowledge on what is allowed and what is not allowed and areas that need to be looked at for a thorough investigation
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- By Meena Chettiar
Design Control / Ddesign and Development Requirements / Documents Under 21 CFR 820/ ISO 13485 7.3
MP3 Download This webinar will provide valuable guidance to regulated companies in development and implementation of Design Control Planning and Techniques for new product development
- Course
- By John E Lincoln
Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR) – A Technical Documentation Training
Apr 29 This seminar will examine the existing and proposed requirements for the U.S. FDA
- Course
- By John E Lincoln
Developing an Effective Strategy for Testing Raw Materials in Phase 1 Through Phase 3 Environment
This live training will cover testing requirements during each Phase and what may be optional until the product moves to its next Phase
- Course
- By Barry A. Friedman
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