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Developing the Master V&V Plan to Meet U.S. FDA, ISO 13485 and 14971 Requirements
MP3 Download In this webinar he will also discuss the consideration of the FDA’s concerns over which device functions
John E Lincoln John E Lincoln
$198
Useful Statistical Methods for Defining Product and Process Specifications
MP3 Download This webinar covers useful and important statistical methods that assist scientists and engineers in the development of appropriate product and process specifications
Steven Wachs Steven Wachs
$399
FDA's Latest Guidance for Cybersecurity for Medical Devices: Quality Management System and Premarket Submission Considerations
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
$199
Stability Studies & Estimating Shelf Life
MP3 Download This webinar discusses the steps to design a stability study and analyze the results to estimate the product's shelf life
Steven Wachs Steven Wachs
$199
Corrective and Preventive Action (CAPA) - Principles of Lean Documents and Lean Configuration
MP3 Download This webinar presents a fresh new approach based upon solid principles and proven practices
Jose Mora Jose Mora
$199
Statistical Process Control (SPC) Training
This seminar will provide attendees with the statistical tools necessary to monitor processes to ensure the quality
Elaine Eisenbeisz Elaine Eisenbeisz
$895
Traditional Computer System Validation and More Novel Computer Software Assurance (CSA): Finding the Best Approach
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
$199
Avoid Warning Letters in View of the U.S. FDA's Stated Goal
MP3 Download FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies.
John E Lincoln John E Lincoln
$199
GCP/GLP/GMP : Comparison and Understanding of the FDA’s 3 Major Regulations
MP3 Download This web presentation presents an overview of FDA’s 3 major regulations
John E Lincoln John E Lincoln
$199
GMPs for MICROBIOLOGISTS — The Manufacturing Environment
Feb 06 The objective of this live, interactive Executive Conference Corp (ECC) webinar is to obtain an enhanced understanding
Barry A. Friedman Barry A. Friedman
$386
GMP master class – get it right to avoid compliance issues
MP3 Download This training will provide foundation to your GMP training.
Charles H. Paul Charles H. Paul
$1,295
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
John E Lincoln John E Lincoln
$249
Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software
MP3 Download This webinar will include a comparison of the Agile and Waterfall methodologies, along with the pros and cons of each
Carolyn Troiano Carolyn Troiano
$189
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
Risk Management for Medical Devices per ISO 14971
MP3 Download This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview
Jose Mora Jose Mora
$199
Preparing for and Managing Successful FDA Inspections
MP3 Download This seminar, you will learn how to properly alert key members that an investigator
Danielle DeLucy Danielle DeLucy
$1,295
Strategies for Substantiating Structure-Function Claims for Dietary Supplements in the United States
Jan 18 Dietary Supplement companies must ensure that any product claims they make are “truthful and not misleading” under FDA and FTC regulations
Travis Austin MacKay Travis Austin MacKay
$399
Data Integrity -- US FDA Requirements
MP3 Download This webinar will focus on the key issues raised by the FDA, not just for products
John E Lincoln John E Lincoln
$287
Hypothesis Testing, p-values, and Inference: When Thinking Like a Statistician Makes Sense
MP3 Download You will learn the why and how of the scientific method, and how to view the world
Elaine Eisenbeisz Elaine Eisenbeisz
$299
Efficient Batch Record Review and Product Release Course
MP3 Download Duration 240 Minutes
Danielle DeLucy Danielle DeLucy
$599
How to write SOP's that Avoid Human Error
MP3 Download This Webinar will discuss the primary cause of quality and production losses in many industries
Ginette Collazo Ginette Collazo
$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
2024 Human Error Prevention & GMP Training Course - New
MP3 Download this training would provide tools that can be implemented and used after this event.
Ginette Collazo Ginette Collazo
$499
FDA’s Regulation of OTC Drug Products : What It Is, How to Analyze It, Make It Work for You
MP3 Download this training will Gain a comprehensive understanding of how OTC Drug Products are regulated in the U.S. Pharmaceutical and Biotech.
Karl M. Nobert Karl M. Nobert
$1,295
Annual Product Quality Reviews; Preparation & Reports - FDA, EU, & Canada Regulatory Requirements
MP3 Download In this live training webinar we will discuss the world-wide regulatory requirements for Annual product Reviews (or Product Quality Reviews).
John G. Lanese John G. Lanese
$399
Conducting Successful Quality Audits: Best Practices for Managing Inspection Situations
Jan 30 In this 90-minute accredited training, you will learn the importance of having a good
Danielle DeLucy Danielle DeLucy
$249
Supervising a Human Error Free Environment: You can do a Lot More than you Think
MP3 Download How can we prevent human error? This 90 -minutes online course will discuss why supervision is so important in reducing and preventing human error
Ginette Collazo Ginette Collazo
$179
Dealing with Out of Specification Test Results in FDA Regulated Industries
MP3 Download This webinar with a thorough knowledge on what is allowed and what is not allowed and areas that need to be looked at for a thorough investigation
Meena Chettiar Meena Chettiar
$199
Tips for setting up a Quality System to withstand FDA Audits for Medical Device and Pharmaceutical Companies
MP3 Download This webinar will provide a step by step approach and valuable tips for setting up a Quality System to withstand FDA Audits
Meena Chettiar Meena Chettiar
$199
Developing an Effective Strategy for Testing Raw Materials in Phase 1 Through Phase 3 Environment
This live training will cover testing requirements during each Phase and what may be optional until the product moves to its next Phase
Barry A. Friedman Barry A. Friedman
$299
Aseptic Technique and Cleanroom Behavior – Avoiding Human Error
MP3 Download this course we will review how quality systems helps in defining requirements for cleanrooms
Danielle DeLucy Danielle DeLucy
$491
The Microbiology of Water in a GMP Environment; USP, EP, JP and FDA Requirements for Potable Water, Purified Water, Water for Injection and Steam
MP3 Download This webinar will examine a variety of issues surrounding water in a facility to include the testing of each water source.
Barry A. Friedman Barry A. Friedman
$199
Non-conforming Materials in a Medical Device Company – dealing with in-house to field issues
MP3 Download Join industry expert Susanne Manz to learn online the essentials of dealing with non-conforming material and performing effective failure
Susanne Manz Susanne Manz
$399
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
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
EU MDR Implementation and Transitioning to the Deadline: Essential Tasks to Complete
MP3 Download This 2-day virtual seminar will go into the specifics of the European Union Medical Device Regulation (EU MDR), provide case studies and share le
Kelly Thomas Kelly Thomas
$3,999

Bundles

GMP Laboratory Control Professionals Certification Program
WCS 6-part GMP Laboratory Control Certification program provides the key principles and tools required to become a GMP Laboratory Control Professional.
Courses: 6
$1,295
Sterilization Professionals Certification Program
WCS 5-Part Sterilization Professional Certification program provides detailed training on the key principals and tools required to become a Sterilization Professional
Courses: 5
$1,495
Pharmacovigilance Certification
Pharmacovigilance Online Courses & Certifications
Courses: 2
$3,995
Good Manufacturing Practices (GMP) Certification Course
Online GMP Training courses
Courses: 4
$1,495
FDA Inspection Readiness Certification Program
The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations.
Courses: 7
$1,495
US Dietary Supplements Certification
US Dietary Supplements Virtual Course Online
Courses: 3
$3,995
Lyophilization Basics for Pharmaceuticals
8 hrs Instructor-led Virtual Seminar -Lyophilization Pharmaceutical Course
Courses: 2
$1,295