Analytical Method Validation, Verification and Transfer

Jun 07-08 In this course, general guideline for the determination of the analytical characteristics for different types of validation procedures

Kelly Thomas

$1,495

The 6 Most Common Problems in FDA Software Validation and Verification

Jun 13 This webinar covers the fundamentals of 21 CFR Part 11, software validation, and computer system validation

David Nettleton

$399

FDA Computer System Validation ( CSV) Training 3 Days Virtual Seminar

Aug 14-15 This Course will explain how to comply with key FDA and international CSV regulations

Carolyn Troiano

$1,699

Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)

Aug 17-18 The lifecycle concept, new to these Guidance, link product and process development, qualification of the commerc

Barry A. Friedman

$1,199

Computer System Validation ( CSV) 3 Day Seminar

Sep 11-13 3 day CSV course will teach you how to comply with key FDA and international CSV

Carolyn Troiano

$1,495

Introduction to Computer System Validation

MP3 Download This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology

Carolyn Troiano

$795

Computer System Validation (CSV) and Data Integrity for Clinical Trials Regulated by FDA

MP3 Download we will discuss what is needed to prepare for an FDA inspection of computer systems and data used in support of clinical trials.

Carolyn Troiano

$1,495

Medical Device Process Validation Training for Professionals

MP3 Download This 90-minute session on risk-based verification and validation planning will discuss "must have" elements from the U.S. FDA cGMP, EU MDR, ICH Q9 and ISO 14971

John E Lincoln

$229

FDA Compliance and Clinical Trial Computer System Validation Core Requirements, Expectations and Challenges

MP3 Download In this two day Virtual Seminar you will learn about FDA's expectations for classifying, assessing the risk, testing, and validating a computer system used in clinical trial work.

Carolyn Troiano

$1,295

The Most Common Problems in FDA Software Validation & Verification

MP3 Download This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models

John E Lincoln

$199

Computer System Validation for Cloud and COTS Applications

May 03-05 The attendee will learn about FDA’s approach to modernizing technology, and how that will benefit both the Agency and industry

Carolyn Troiano

$1,495

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

Carolyn Troiano

$1,295

Analytical Method Validation Under Good Laboratory Practices (GLP) Live Webinar

MP3 Download Participants will understand - Is validation a regulated activity? When to pull the trigger for validation? Importance of suitability testing

John C. Fetzer

$189

Computer Software Assurance (CSA) Approach to Validation: Using Agile and Automated Testing

MP3 Download Computer Software Assurance (CSA) Approach to Validation: Using Agile and Automated Testing

Carolyn Troiano

$249

Computer System Validation Professional Certification Program 3 Days

MP3 Download The course moves quickly and participants will change gears often to keep interest high and accommodate multiple learning styles

Carolyn Troiano

$1,295

The Validation Master Plan - The Unwritten Requirements

MP3 Download This 60-minute session on master verification and validation planning will discuss the major cGMP deficiencies and "must have" elements from the U.S

John E Lincoln

$199

Analytical Method Validation and Transfer

MP3 Download This course will provide a thorough review of regulatory guidelines on method validation and transfer

Kelly Thomas

$229

Essentials of Validation - IQ, OQ, PQ

MP3 Download This course will cover the validation essentials for medical device manufacturers

Susanne Manz

$179

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.

Carolyn Troiano

$499

Risk Based Verification and/or Validation to meet US FDA CGMP and ISO 13485 Requirements

MP3 Download This Webinar will provide valuable assistance to all regulated companies that need to review and modify their Master Validation Planning.

John E Lincoln

$199

Full Day Virtual Workshop Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Syst

MP3 Download This webinar will aim at understanding and scoping out various phases of Qualification activities that will be integrated

Joy L. McElroy

$695

Verification and Validation - Product, Equipment / Process, Software, QMS+

MP3 Download This seminar will provide valuable assistance to all regulated companies that need to review and modify their Master Validation Planning and Plan(s).

John E Lincoln

$1,295

Computer System Validation Boot Camp®

The course moves quickly and participants will change gears often to keep interest high and accommodate multiple learning styles

Carolyn Troiano

€2.800

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

Kelly Thomas

$299

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

Jose Mora

$399

Computer System Validation Professional Certification Program 3 Days

Dec 8-10 , 2021 This course will completely immerse you in computer system validation and delivers comprehension of the regulations impacting your system

Carolyn Troiano

€1.295

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

Carolyn Troiano

$179

Webinar Analytical Method Validation and Transfer According to the New FDA Guidance

MP3 Download This course will prepare attendees with the knowledge and tools to plan and execute test method validation packages for the NDA

Kelly Thomas

$499

Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements

MP3 Download This webinar will give you a comprehensive understanding of this important subject with an emphasis on the different types of sterilizing

Roger Cowan

$299

Understanding the Design Verification and Validation Requirements for Medical Devices

MP3 Download Duration 60 Minutes

Meena Chettiar

$199

Learn the latest webinar Software Validation Utilizing Principles of Lean Documents and Lean Configuration

24-Feb,2021 at 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Jose Mora

$199

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

John E Lincoln

$399

Understanding the Design Verification and Validation Requirements for Medical Devices

MP3 Download Duration 60 Minutes

Meena Chettiar

$199

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

MP3 Download Duration 90 Minutes

Carolyn Troiano

$199

What You Need to Know IEC 62304 and Demystifying Software Validation using the Principles of LDLC

MP3 Download Duration 180 Minutes

Jose Mora

$299

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

MP3 Download Duration 90 Minutes

Carolyn Troiano

$299