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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 John E Lincoln
$229
How Will FDA’s New Approach to CSV Make Implementations Easier?
MP3 Download In this webinar, we will dissect the new CSA approach and explore the key matrices/tools needed to make solid risk determinations
Carolyn Troiano Carolyn Troiano
$265
Master the Vendor Auditing of your Computer Systems Regulated by FDA
MP3 Download This webinar will provide the best industry practices to follow when auditing a vendor of a computer system
Carolyn Troiano Carolyn Troiano
$265
Project Management Bootcamp
MP3 Download This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly
Charles H. Paul Charles H. Paul
$1,495
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
Carolyn Troiano Carolyn Troiano
$895
Part 11 Data Integrity and Cybersecurity – The Latest Developments
MP3 Download The cGMPs have been around for decades. Electronic documentation requirements are newer. Initially there were regulations such as 21 CFR Part 11
John E Lincoln John E Lincoln
$499
SDLC Modernization Continuous Quality in an FDA-Regulated Environment and Journey to Paperless SDLC/CSV
MP3 Download This Webinar provide an overview of industry best practices, with a focus on data integrity and risk assessment that can be leveraged to assist in all your GxP work.
Carolyn Troiano Carolyn Troiano
$249
concerning "Recall vs. Enhancement”
MP3 download The medical device industry often fumbled with what to report and what not to report as a recall to the FDA.
Casper (Cap) Uldriks Casper (Cap) Uldriks
$199
GMP Auditing for Quality Assurance Training Course for FDA Regulated Industries
MP3 Download GMP Auditing for the Pharmaceutical Industry
Kelly Thomas Kelly Thomas
$1,495
Building the Project Charter, Project Scope Statement, and the Priority Matrix
MP3 Download This webinar will explain the role of each document in the project management process and their importance
Charles H. Paul Charles H. Paul
$299
The FDA recently released a new draft guidance related to Part 11
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
$299
Developing Training in Regulated Environments
MP3 DDownload This webinar will explore the area of training in regulated environments, its importance, and its relationship to compliance documentation
Charles H. Paul Charles H. Paul
$995
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
$1,295
FDA’s Import Alerts
MP3 Download This webinar will provide attendees with background about FDA Import Alerts, examine why they are issues
Karl M. Nobert Karl M. Nobert
$399
Medical Device Change(s) and the 510(k)
MP3 Download This webinar will provide valuable assistance to all regulated companies performing and documenting meaningful, results driven 510(k) / change analysis activities
John E Lincoln John E Lincoln
$265
Data Integrity by Design, Pharma 4.0 and Overcoming DI issues in the Cloud
MP3 Download This webinar will show how exactly is Data Integrity by Design important for achieving Pharma 4.0 and how its implementation can overcome issues of cloud computing.
Carolyn Troiano Carolyn Troiano
$199
cGMP Regulatory Inspections - Through the Eyes of FDA, EMA and PMDA
MP3 Download This webinar will cover the key areas of how ICH Q7 was established, it's goals and objectives, expectations of the healthcare authorities
Kelly Thomas Kelly Thomas
$495
FDA & OSHA Warehouse Requirements
MP3 Download The webinar will provide attendees with an overview of the FDA’s warehousing regulatory requirements and offer strategic recommendations for compliance with those rules
Karl M. Nobert Karl M. Nobert
$249
Project Management for FDA-Regulated Companies in the Postpandemic World: Are You Ready for New Approaches and Methods?
MP3 Download This webinar will provide valuable guidance to regulated companies in development and implementation of new Lean Project Management Planning concepts including some Agile principles
John E Lincoln John E Lincoln
$299
Pharmaceutical Document Management Training Course - A Global Regulatory Approach
MP3 Download This course is designed for individuals responsible for documentation writing and management in the pharmaceutical and related industries
Kelly Thomas Kelly Thomas
$1,495
Tips and Tricks for Project Management Success
MP3 Download This webinar will outline those tips along with a discussion of the project management tools that apply.
David R. Dills David R. Dills
$299
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 Best Audit Practices – get ready for the inspection that is coming
MP3 Download This webinar will begin by discussing and emphasizing the importance of truthfulness to the process
Charles H. Paul Charles H. Paul
$265
Structuring and Conducting Risk-Based Internal cGMP Compliance Audits
MP3 Download This training will evaluate the chief areas of an FDA cGMP compliance audit and help you understand the actual and anticipated changes
John E Lincoln John E Lincoln
$199
Half Day Virtual Seminar on Fundamentals of Toxicology
MP3 Download The course will cover these aspects that are relevant for non-toxicologists involved in drug development.
Dr. Stefano Persiani Dr. Stefano Persiani
$795
Controlling Human Error in the manufacturing floor
MP3 Download This course offers practical approaches and tools to address human performance issues in GMP related environments
Ginette Collazo Ginette Collazo
$299
CROs (Clinical Research Organizations) - Identification, Selection, and Management for Maximum Results & Value
MP3 Download This course will provide the attendees with all the specific methodology and management techniques to successfully outsource pharmaceutical programs
Kelly Thomas Kelly Thomas
$1,495
GMPs for the Life Sciences – 12-Hour Virtual Seminar
MP3 Download This training will provide foundation to your GMP training.
Charles H. Paul Charles H. Paul
$1,295
PK/PD Studies in Drug Discovery and Development
MP3 Download The webinar reviews the general concepts and basic elements of pharmacokinetics, pharmacodynamics, and their correlation
Dr. Stefano Persiani Dr. Stefano Persiani
$199
A Culture of Quality is a Competitive Advantage in 2023
MP3 Download This webinar will help you to imbed a culture of quality throughout your organization. We will discuss concepts for creating a culture of quality
Susanne Manz Susanne Manz
$299
Complaint Handling Requirements
MP3 Download This 90-minute accredited course is intended to help you better understand and get familiar with the requirements for complaint files and key requirements
Danielle DeLucy Danielle DeLucy
$199
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
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
John E Lincoln John E Lincoln
$199
Statistical Process Control (SPC) One Day Masterclass
MP3 Download This seminar will provide attendees with the statistical tools necessary to monitor processes to ensure the quality of manufactured products
Elaine Eisenbeisz Elaine Eisenbeisz
$996
510(k) and PMA Submissions Process
MP3 Download This webinar will detail the 510K and PMA processes as well as the EU directives comparing and contrasting those regulations
John E Lincoln John E Lincoln
$265
2 Day Virtual Seminar on REACH and RoHS Compliance: Protecting Revenues with Advanced Compliance
MP3 Download This 2 day seminar will go into the specifics of the REACH and RoHS regulations, provide case studies and share lessons learned so your
Kelly Eisenhardt Kelly Eisenhardt
$1,899