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Computer System Validation (CSV) vs. Computer Software Assurance (CSA): Following a Waterfall vs. Agile Methodology

Available until

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
%
COMPLETE
$499
Assessment of Drug-drug Interactions in Drug Development

Available until

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
%
COMPLETE
$199
Transfer Of Methodology

Available until

MP3 Download Even a detailed and well-written standard operating procedure for a method cannot ensure that 2 laboratories
John C. Fetzer John C. Fetzer
%
COMPLETE
$189
Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices

Available until

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
%
COMPLETE
$1,299
Purchasing Controls and Receiving Acceptance for Medical Devices

Available until

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
%
COMPLETE
$229
Good Documentation Practices

Available until

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
%
COMPLETE
$199
FDA's Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices

Available until

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
%
COMPLETE
$249
Risk Based Verification and/or Validation to meet US FDA CGMP and ISO 13485 Requirements

Available until

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
%
COMPLETE
$199
Biomarkers in Drug Discovery and Development

Available until

MP3 Download The topics that will be discussed potential benefits of a biomarker in drug development are very significant
Dr. Stefano Persiani Dr. Stefano Persiani
%
COMPLETE
$199
Production and Process Controls for Medical Devices What You Need to Know

Available until

MP3 Download This webinar can help you prevent serious issues such as these. You’ll learn about FDA quality system regulation expectations, and how you can
Susanne Manz Susanne Manz
%
COMPLETE
$249
Investigation of Out-of-Specification Test Results

Available until

MP3 Download Attendees will learn the FDA expectations when investigating out-of-specification and out-of-trend laboratory results.
Paul Larocque Paul Larocque
%
COMPLETE
$265
The European PSMF

Available until

MP3 Download This course teaches you with evolution of the PSMF and the legislation concerning it for the EU, sections of the PSMF, annexes of the PSMF
Graeme Ladds Graeme Ladds
%
COMPLETE
$249
Full Day Virtual Workshop Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Syst

Available until

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
%
COMPLETE
$695
Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions Virtual Training

Available until

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
%
COMPLETE
€1.895
Verification and Validation - Product, Equipment / Process, Software, QMS+

Available until

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
%
COMPLETE
$1,295
3 Hrs Webinar on What You Need to Know: Investigating Out-of-Specification (OOS)

Available until

MP3 Download This webinar will review the regulatory requirements for investigating an OOS Investigation.
Danielle DeLucy Danielle DeLucy
%
COMPLETE
$399
2 Day Virtual Seminar on FDA Inspection Essentials in 2022

Available until

MP3 Download This seminar, you will learn how to properly alert key members that an investigator has arrived, the proper protocol
Danielle DeLucy Danielle DeLucy
%
COMPLETE
€1.295
Write it Right – Standard Operating Procedures

Available until

MP3 Download This webinar will help you to write complete, clear, unambiguous, and flexible SOPs.
Susanne Manz Susanne Manz
%
COMPLETE
$487
What You Need to Know: Auditing EU-MDR and EU-IVDR Implementation

Available until

MP3 DowIoad this webinar you will learn about Auditing EU-MDR and EU-IVDR Implementation. We’ll share insights on the importance of good project management
David R. Dills David R. Dills
%
COMPLETE
$399
Complaint Management: Best Practices to Assure Regulatory Compliance and Customer Retention

Available until

MP3 Download This session will include the requirements for all of the above responsibilities, which will include defining, documenting, and implementing
Jeff Kasoff Jeff Kasoff
%
COMPLETE
$249
Writing Excellent SOPs Webinar

Available until

MP3 Download You will learn techniques for creating concise and easy to read SOPs that your employees can understand and will follow
Susanne Manz Susanne Manz
%
COMPLETE
$179
Purchasing Controls, Supplier Management, and Receiving Acceptance for Medical Devices

Available until

MP3 Download This 2-day virtual seminar can help you understand your responsibilities in terms of Purchasing Controls enabling you to provide safe
Susanne Manz Susanne Manz
%
COMPLETE
$1,295
Annual Current Good Manufacturing Practices (cGMP) Training

Available until

MP3 Download This webinar provides a basic understanding and fundamental principles of Current Good Manufacturing Practices and will fulfill the requirement
Kelly Thomas Kelly Thomas
%
COMPLETE
$229
Pharmaceutical Compressed Air Quality GMP Requirements - What you need to know to meet FDA and Inte

Available until

MP3 Download This webinar will give you an understanding of the different types of contamination inherent in compressed air
Roger Cowan Roger Cowan
%
COMPLETE
$199
Computer System Validation Boot Camp®

Available until

The course moves quickly and participants will change gears often to keep interest high and accommodate multiple learning styles
Carolyn Troiano Carolyn Troiano
%
COMPLETE
€2.800
The Veterinary Drug Approval Process and FDA Regulatory Oversight

Available until

MP3 Download This two-day seminar will provide attendees with an understanding of FDA’s veterinary drug approval process, obtaining federal government
Karl M. Nobert Karl M. Nobert
%
COMPLETE
€1.295
FDA’s Ambitious Regulation of Social Media - New Course By FDA Investigator

Available until

MP3 Download This webinar teach us about social media platforms provide common ways to cross FDA’s legal boundaries for “misbranding” your product
Casper (Cap) Uldriks Casper (Cap) Uldriks
%
COMPLETE
$229
3 Hrs Virtual Webinar on Aseptic Processing and Validation

Available until

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
%
COMPLETE
$299
Hypothesis Testing, p-values, and Inference: When Thinking Like a Statistician Makes Sense

Available until

MP3 Download You will learn the why and how of the scientific method, and how to view the world with a statistician’s eyes
Elaine Eisenbeisz Elaine Eisenbeisz
%
COMPLETE
$499
FDA Inspections – Proven Preparation & Survival Techniques : What Regulators Expect and How to Prepare

Available until

MP3 Download This seminar will help you use the FDA inspection as a learning tool, not as a negative or adversarial experience.
Danielle DeLucy Danielle DeLucy
%
COMPLETE
$3,995
Data Integrity: FDA, WHO and EMA's Requirements

Available until

MP3 Download This two day seminar is to explore and define the necessary elements in the development and implementation of a Data Integrity program
Barry A. Friedman Barry A. Friedman
%
COMPLETE
$1,495
3Hour Virtual Seminar on IEC 62304 and Demystifying Software Validation using the Principles of LDLC

Available until

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
%
COMPLETE
$399
FDA’s Plan to Modernize the 510(k) Pathway: What Regulatory, Quality and Compliance Professionals Need to Know

Available until

MP3 Download This webinar will discuss the 510(k) framework to reflect advances in device technology, safety and capabilities, making it harder to obtain
John E Lincoln John E Lincoln
%
COMPLETE
$287
Multiplicity: When and How to Adjust for Multiple Testing

Available until

MP3 Download this webinar will explain the differences between family wise error rate (FWER) and false discovery rate (FDR).
Elaine Eisenbeisz Elaine Eisenbeisz
%
COMPLETE
$249
Medical Device Cybersecurity and FDA Compliance

Available until

MP3 Download This webinar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products
Carolyn Troiano Carolyn Troiano
%
COMPLETE
$695
Audits in the World of COVID-19 and Beyond: Are You Ready for Remote Audits?

Available until

MP3 Download The presentation will provide an insight and guidance to managers with QA departments to implement a Remote Auditing program
Michael Ramcharan Michael Ramcharan
%
COMPLETE
$229
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