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21 CFR Part 11, FDA's Guidance for Electronic Records and Electronic Signatures
MP3 Download 21 CFR Part 11, FDA's Guidance for Electronic Records and Electronic Signatures
Carolyn Troiano Carolyn Troiano
$249
FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control
MP3 Download This webinar will discuss the FDA requirements and guidelines for investigating Out-of-trend (OOT) results in the pharmaceutical laboratory
Kelly Thomas Kelly Thomas
$229
US Dietary Supplements - Regulatory Compliance Requirements, Product Claims, Labeling Issues and FDA Updates
MP3 Download This 120 minute training will review the dietary supplement regulations and discuss how to verify that your products are compliant
Travis Austin MacKay Travis Austin MacKay
$399
Advanced Pharmacovigilance Auditing and Inspections Virtual Live Training Course
MP3 Download Pharmacovigilance Auditing Inspection course will explain how to prepare for the audit inspection, overview of the European Medicines Agency's Guid
Michael Ramcharan Michael Ramcharan
$1,695
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 Carolyn Troiano
$1,495
A Comprehensive View of Medical Device Post-Market Regulations and Challenges During COVID-19— Complaint Handling, MDR Reporting and Recalls
MP3 Download This course will explain how to comply with complicated Complaint Handling, MDR and Recall requirements. Earl Bird. Register.
Rita Hoffman Rita Hoffman
$1,295
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
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
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
Project Management for Non-Project Managers – PM in the Life Sciences – Pharmaceutical/ Biotechnology and Medical Devices
MP3 Download This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective
Charles H. Paul Charles H. Paul
$4,665
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
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
The DHF, DMR, DHR, EU MDR Technical Documentation Similarities, Differences and The Future
MP3 Download This seminar will examine the existing and proposed requirements for the U.S. FDA's DHF - including its derivative documents, the DMR, and DHR. It will consider the European Union's new MDR
John E Lincoln John E Lincoln
$599
Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Product
MP3 Download 2 Day Virtual Seminar
Karl M. Nobert Karl M. Nobert
$1,395
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
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
Strategies for Substantiating Structure-Function Claims for Dietary Supplements in the United States
MP3 Download The Federal Food, Drug, and Cosmetic Act requires that a manufacturer of a dietary supplement making a nutritional deficiency
Travis Austin MacKay Travis Austin MacKay
$399
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
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
Writing and implementing a Standard Operating Procedure (SOP) in a Compliant Laboratory (US FDA, US EPA and OSHA Focus)
MP3 Download This seminar will describe the requirements, the dos and don’ts commonly performed by laboratories, the writing of a Standard Operating Procedure
John C. Fetzer John C. Fetzer
$995
Drug Development: Key to Success from Concept to Commercialization
MP3 Download This 2 Day Virtual Seminar is designed to teach employees of pharmaceutical companies who would like an understanding
Karl M. Nobert Karl M. Nobert
$1,295
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
Risk Management of Raw Materials in a GMP Environment
MP3 Download The live training webinar will explore the number of lots required to be tested before reduced testing might occur
Barry A. Friedman Barry A. Friedman
$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
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
Promoting and Advertising Dietary Supplements in Compliance with FDA and FTC Regulations
MP3 Download This webinar will review the applicable regulations, walk you through real-life situations, help you address compliance, and provide practical strategies to mitigate enforcement actions
Travis Austin MacKay Travis Austin MacKay
$399
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
Project Management for Non-Project Managers – PM in the Life Sciences – Pharmaceutical/ Biotechnology and Medical Devices
MP3 Download This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective
Charles H. Paul Charles H. Paul
€1.495
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
ISO 13485 – Medical Device Quality Management Systems
MP3 Download The ISO standard is also a valuable tool to the establishment, maintenance, and execution of the organization’s QMS
Charles H. Paul Charles H. Paul
$265
Computer System Validation ( CSV) 3 Day Seminar
MP3 Download 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
€1.495
Fundamentals of Toxicology for the Pharmaceutical Industry
MP3 Download The webinar will cover these aspects that are relevant for non-toxicologists involved in drug development
Dr. Stefano Persiani Dr. Stefano Persiani
$199
Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance Webinar
MP3 Download This course will provide a condensed overview of the key practices that deliver the best results by directing the attendees
Carolyn Troiano Carolyn Troiano
$249
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 John E Lincoln
$199