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Computer System Validation ( CSV) 3 Day Virtual Seminar
May 18-20 3 day CSV course will teach you how to comply with key FDA and international CSV regulations and guidance, such as 21 CFR Part 11 and Annex 11.
Carolyn Troiano Carolyn Troiano
$2,950
Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)
May 24-25 , 2022 The lifecycle concept, new to these Guidance, link product and process development, qualification of the commerc
Barry A. Friedman Barry A. Friedman
$1,593
Computer Software Assurance (CSA) Approach to Validation: Using Agile and Automated Testing
June 01 Computer Software Assurance (CSA) Approach to Validation: Using Agile and Automated Testing
Carolyn Troiano Carolyn Troiano
$249
FDA Compliance and Clinical Trial Computer System Validation Core Requirements, Expectations and Challenges
June 2-3 , 2022 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 Carolyn Troiano
$1,295
Lyophilization Basics for Pharmaceuticals: Scale-Up, Validation, Deviations
June 07 This course will provide an overview of the process, and suggest approaches that may be considered
Lisa Hardwick Thompson Lisa Hardwick Thompson
$299
The Most Common Problems in FDA Software Validation & Verification
July 06 This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models
John E Lincoln John E Lincoln
$199
Computer System Validation Professional Certification Program 3 Days
July 21-13 , The course moves quickly and participants will change gears often to keep interest high and accommodate multiple learning styles
Carolyn Troiano 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 John E Lincoln
$199
Computer System Validation for Cloud and COTS Applications
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 Carolyn Troiano
$1,495
FDA Computer System Validation ( CSV) Training 3 Days Virtual Seminar
MP3 Download This Course will explain how to comply with key FDA and international CSV regulations and guidance, such as 21 CFR Part 11 and Annex 11.
Carolyn Troiano Carolyn Troiano
$1,295
Analytical Method Validation and Transfer
MP3 Download This course will provide a thorough review of regulatory guidelines on method validation and transfer
Kelly Thomas Kelly Thomas
$229
Essentials of Validation - IQ, OQ, PQ
MP3 Download This course will cover the validation essentials for medical device manufacturers
Susanne Manz 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 Carolyn Troiano
$499
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 Carolyn Troiano
$1,495
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 John E Lincoln
$199
Analytical Method Validation, Verification and Transfer
MP3 Download In this course, general guideline for the determination of the analytical characteristics for different types of validation procedures
Kelly Thomas Kelly Thomas
$1,498
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 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 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 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 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 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 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 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 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 Roger Cowan
$299
Understanding the Design Verification and Validation Requirements for Medical Devices
MP3 Download Duration 60 Minutes
Meena Chettiar 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 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 John E Lincoln
$399
Understanding the Design Verification and Validation Requirements for Medical Devices
MP3 Download Duration 60 Minutes
Meena Chettiar Meena Chettiar
$199
Best Practices To Help You Pass An FDA Computer System Validation Audit
MP3 Download Duration 90 Minutes
Carolyn Troiano 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 Jose Mora
$299
Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall
MP3 Download Duration 90 Minutes
Carolyn Troiano Carolyn Troiano
$299
Medical Device Software: Verification, Validation & Compliance
MP3 Download Duration 60 Minutes
Nancy Knettell Nancy Knettell
$229
Issues in Calibrations and Accuracy in Method Validation
MP3 Download Duration 60 Minutes
John C. Fetzer John C. Fetzer
$199
Understanding the Process Validation Life Cycle
MP3 Download Duration 90 Minutes
Danielle DeLucy Danielle DeLucy
$199
FDA Regulations for Analytical Instrument Qualification and Validation Processes
MP3 Download Duration 90 Minutes
Joy L. McElroy Joy L. McElroy
$279