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Courses

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
Charles H. Paul Charles H. Paul
$1,295
Mobile Device Apps and the FDA – Classification, Regulatory Requirements and Cybersecurity
MP3 Download This has resulted in the FDA focusing on the subset of software functions dealing
John E Lincoln John E Lincoln
$265
The Project Management Plan
MP3 Download This webinar will introduce the concept of planning and how it is conducted
Charles H. Paul Charles H. Paul
$299
Efficient Batch Record Review and Product Release Course
MP3 Download Duration 240 Minutes
Danielle DeLucy Danielle DeLucy
$599
Trial Master File and Clinical Data Management Regulated by FDA
MP3 Download This FDA compliance training will cover in detail the new requirements for trial master files
Carolyn Troiano Carolyn Troiano
$199
Human error in the life sciences – mitigate your potential for error occurring
MP3 Download This webinar will explore the true causes and nature of human error, how human error should be investigated
Charles H. Paul Charles H. Paul
$265
GMPs for MICROBIOLOGISTS — The Manufacturing Environment
MP3 Download The objective of this live, interactive Executive Conference Corp (ECC) webinar is to obtain an enhanced understanding
Barry A. Friedman Barry A. Friedman
$385
FDA Inspection Essentials in 2023
MP3 Download In this accredited, 90 minute online course, you will learn how to properly alert key members that an investigator has arrived, the proper
Danielle DeLucy Danielle DeLucy
$265
Effective Technical Writing in the Life Sciences – bullet-proof your technical documentation
MP3 Download This virtual seminar will walk you through the technical writing process from start to finish
Charles H. Paul Charles H. Paul
$595
Part 11 Data Integrity and Cybersecurity - The Latest Developments
MP3 Download Data integrity has always been a key component of all the cGMP’s, only now taking on greater emphasis due to the use of electronic records / signatures
John E Lincoln John E Lincoln
$399
Good Documentation Practices for Laboratory Records
MP3 Download This 90-minute accredited course is designed to provide sound training on “good documentation practices” in the laboratory
Danielle DeLucy Danielle DeLucy
$265
Stability Studies and Est 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
$499
Inspection and Audit Readiness Training for Medical Device Manufacturers
July 07 This course focuses on identifying FDA inspection criteria, resources (including key standard operating procedures such as CP 7382.845)
John E Lincoln John E Lincoln
$699
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
For SPC Book camp
MP3 Download The webinar will cover chart construction, chart interpretation, and ongoing management of the monitoring process
Steven Wachs Steven Wachs
$499
Blockchain Innovations that Connect and Protect the Supply Chain
MP3 Download This training program will discuss the new blockchain innovations particularly as they can be used to connect and protect the regulated supply chain
John E Lincoln John E Lincoln
$265
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
FDA Case Scenarios: Best Practices for Managing Inspection Situations
MP3 Download In this 90-minute accredited course, you will hear about real life examples of inspection issues on different topics such as Opening Day, Documentation, Tours, SME situations, Safety
Danielle DeLucy Danielle DeLucy
$265
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
Introduction to Computer System Validation
MP3 Download This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology
Carolyn Troiano Carolyn Troiano
$795
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
Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products 2 Day Course
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
$1,495
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
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
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
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

Bundles

Test 1
Courses: 4
$1,000