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A risk based approach to GxP Compliant Laboratory Computerized Systems in the COVID-19 Era and Beyond
MP3 Download This hands-on seminar provides a practical, risk based approach to laboratory computerized system specification, verification, and implementation
Carolyn Troiano Carolyn Troiano
$1,295
Navigating the Medical Device Post-Market Maze and Challenges during COVID-19 Pandemic - Learn what FDA is really thinking on regulation and guidance documents
MP3 Download this course will explain how to comply with complicated Complaint Handling, MDR and Recall requirements. Earl Bird. Register.
Kelly Thomas Kelly Thomas
$1,495
FDA Regulation of Artificial Intelligence/ Machine Learning
MP3 Download This webinar is not a programming course but will explain the present and future regulatory requirements for AI/ML
Edwin Waldbusser Edwin Waldbusser
$265
Biostatistics for the Non-Statistician
MP3 Download this course will have understanding of concepts and statistical methods required in pharmaceutical, biological and medical device.
Elaine Eisenbeisz Elaine Eisenbeisz
$1,495
Data Integrity -- US FDA Requirements
MP3 Download This webinar will focus on the key issues raised by the FDA, not just for products and their manufacture, but expectations
John E Lincoln John E Lincoln
$199
Learn the Latest FDA Compliance and Mobile Applications Live Webinar
MP3 Download This topic is focused on the use of mobile applications to process data regulated by FDA. These applications may be used to collect, analyze
Carolyn Troiano Carolyn Troiano
$299
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
Excel Spreadsheets - Develop and Validate to Eliminate 483s
MP3 Download This session will make you a better Excel user, saving you time and costs
David Nettleton David Nettleton
$199
Biostatistics for the Non-Statistician
MP3 Download this course will have understanding of concepts and statistical methods required in pharmaceutical, biological and medical device.
Elaine Eisenbeisz Elaine Eisenbeisz
€4.665
GMP for Active Pharmaceutical Ingredients
MP3 Download This webinar reviews the requirements for good manufacturing practices for active pharmaceutical ingredients.
Paul Larocque Paul Larocque
$265
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 Carolyn Troiano
$1,295
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
Calculations for Process and Product Capability
MP3 Download This Webinar will focus on providing the information needed for attendees to know the appropriate measures and formulas
Elaine Eisenbeisz Elaine Eisenbeisz
$249
CMO Supplier Quality Agreements - What you need to know to comply with new FDA & EU GMP Guidelines for contract drug manufacture
MP3 Download This Webinar presentation will provide a thorough understanding of the content that is expected in Quality Agreements from a regulatory
Roger Cowan Roger Cowan
$299
Cybersecurity - US FDA Requirements – New Course !
MP3 Download This webinar will consider how cybersecurity is introduced into the CGMPs, design control (21 CFR 820.30) for devices, and post-production
John E Lincoln John E Lincoln
$249
Purchasing Controls, Receiving Inspection, and Supplier Audit – what to do during a global pandemic
MP3 Download This webinar will provide insights into how to use remote auditing techniques to minimize the risk and maximize the benefits of conducting audits
Susanne Manz Susanne Manz
$249
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
John E Lincoln John E Lincoln
$199
Human Error Solutions: How we reduced 60% of human errors in less than a year, a Case
MP3 Download Join this session by expert speaker Ginette Collazo, where she will discuss how by redesigning the training function and by focusing on the expected result
Ginette Collazo Ginette Collazo
$249
Introduction to Medical Device Quality System Regulations
MP3 Download Attendees will learn FDA’s expectations for the implementation and on-going operation of an effective medical device
Paul Larocque Paul Larocque
$265
Quality Systems Inspection Technique (QSIT), and How to use it to Your Advantage
MP3 Download This Webinar provides valuable assistance to all individuals who liaison with the FDA during inspections. It will also benefit senior management
Jeff Kasoff Jeff Kasoff
$249
Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions Virtual Training
MP3 Download The objective of this FIVE HOUR/DAY, ON-LINE two day interactive seminar is to explore raw materials and their requirements – issues and solutions.
Barry A. Friedman Barry A. Friedman
$1,495
Preventing Human Error in the Life Sciences Virtual Seminar (4 hours)
MP3 Download This four hour virtual seminar, will explore the true causes and nature of human error, how human error should be investigated
Charles H. Paul Charles H. Paul
$2,995
Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Product
MP3 Download 2 Day Virtual Seminar
Karl M. Nobert Karl M. Nobert
$1,495
How FDA trains its investigators to review CAPA and what should you do to prepare
MP3 Download This webinar will discuss all the documents used by FDA to train their inspectors to review your CAPA system, some of which you may not be familiar
Jeff Kasoff Jeff Kasoff
$249
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
Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products
MP3 Download The objective of this live, interactive WCS training seminar is to explore the role of aseptic filling to assure that manufactured product
Barry A. Friedman Barry A. Friedman
$1,295
Assessment of Drug-drug Interactions in Drug Development
MP3 Download The topics that will be discussed during the webinar include the investigation of CYP enzyme- and transporter-mediated drug interactions
Dr. Stefano Persiani Dr. Stefano Persiani
$199
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
Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices
MP3 Download The seminar will provide attendees with a better understanding of responsibilities and gain a greater knowledge of the issues faced
David R. Dills David R. Dills
$1,299
Good Documentation Practices
MP3 Download This presentation will discuss the purpose of good documentation, what proper documentation looks like and a brief discussion of elements
David W. Husman David W. Husman
$199
Purchasing Controls and Receiving Acceptance for Medical Devices
MP3 Download This webinar can help you understand your responsibilities in terms of Purchasing Controls enabling you to provide safe and effective products
Susanne Manz Susanne Manz
$229
21 CFR Part 11 and Annex 11; what you need to know to pass the new regulatory inspections
MP3 Download This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted
David Nettleton David Nettleton
$199
FDA's Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices
MP3 Download The objective of this live training webinar is to explore the NEW/REVISED Guidances for Industry on Pyrogen and Endotoxins Testing. FDA Training
Barry A. Friedman Barry A. Friedman
$249
Lyophilization Basics for Pharmaceuticals: Unit operations, equipment, instrumentation, and performance
MP3 Download Lyophilization Basics for Pharmaceuticals: Unit operations, equipment, instrumentation, and performance
Lisa Hardwick Thompson Lisa Hardwick Thompson
$595
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