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  • Medical device Training (104)
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  • Martin K. Behr
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Project Management for FDA-Regulated Companies in the Postpandemic World: Are You Ready for New Approaches and Methods?

Available until

Feb 08 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
%
COMPLETE
$299
Microbiological Rapid Method Sterility Testing (RMT) of Short Dated and Other Products

Available until

Feb 08 The objective of this live, interactive training Executive Conference Corp webinar is to obtain an enhanced understanding of the new USP General Information Chapter
Barry A. Friedman Barry A. Friedman
%
COMPLETE
$385
Half Day Virtual Seminar on Fundamentals of Toxicology

Available until

Feb 08 The course will cover these aspects that are relevant for non-toxicologists involved in drug development.
Dr. Stefano Persiani Dr. Stefano Persiani
%
COMPLETE
$795
Analytical Method Validation, Verification and Transfer

Available until

Feb 09-10 In this course, general guideline for the determination of the analytical characteristics for different types of validation procedures
Kelly Thomas Kelly Thomas
%
COMPLETE
$1,495
The FDA recently released a new draft guidance related to Part 11

Available until

Feb 09 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
$299
Excel Spreadsheets - Develop and Validate to Eliminate 483s

Available until

Feb 15 This session will make you a better Excel user, saving you time and costs
David Nettleton David Nettleton
%
COMPLETE
$299
Controlling Human Error in the manufacturing floor

Available until

Feb 15 This course offers practical approaches and tools to address human performance issues in GMP related environments
Ginette Collazo Ginette Collazo
%
COMPLETE
$299
Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach

Available until

Feb 15-17 This eight-hour vendor qualification audit training will help you improve quality in your facility.
Kelly Thomas Kelly Thomas
%
COMPLETE
$1,498
PK/PD Studies in Drug Discovery and Development

Available until

Feb 16 The webinar reviews the general concepts and basic elements of pharmacokinetics, pharmacodynamics, and their correlation
Dr. Stefano Persiani Dr. Stefano Persiani
%
COMPLETE
$199
Data Integrity by Design, Pharma 4.0 and Overcoming DI issues in the Cloud

Available until

Mar 07 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
%
COMPLETE
$249
Tips and Tricks for Project Management Success

Available until

Feb 16 This webinar will outline those tips along with a discussion of the project management tools that apply.
David R. Dills David R. Dills
%
COMPLETE
$299
Writing and Enforcing SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations

Available until

Feb 22-24 This course will address how to write effective Standard Operating Procedures and Work Instructions in support of company activities
Kelly Thomas Kelly Thomas
%
COMPLETE
$1,495
Part 11 Data Integrity and Cybersecurity – The Latest Developments

Available until

Feb 24 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
%
COMPLETE
$495
GCP/GLP/GMP : Comparison and Understanding of the FDA’s 3 Major Regulations

Available until

Apr 18 This web presentation presents an overview of FDA’s 3 major regulations – Good Clinical Practices (GCP)
John E Lincoln John E Lincoln
%
COMPLETE
$265
Advanced Pharmacovigilance Auditing and Inspections Virtual Live Training Course

Available until

Feb 23-24 & Mar 15-16 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
%
COMPLETE
$6,995
Introduction to Computer System Validation

Available until

Feb 27 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
%
COMPLETE
$795
Quality and GMP Compliance for Virtual Companies (Pharmaceutical and Biologics Industries)

Available until

Mar 02-03 In this two day workshop conference you will learn the requirements and expectations of major health care regulators that are applicable to "virtual" companies
Kelly Thomas Kelly Thomas
%
COMPLETE
$1,495
Medical Device Change(s) and the 510(k)

Available until

Mar 03 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
%
COMPLETE
$265
cGMP Regulatory Inspections - Through the Eyes of FDA, EMA and PMDA

Available until

Mar 07 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
%
COMPLETE
$495
The 6 Most Common Problems in FDA Software Validation and Verification

Available until

Mar 09 This webinar covers the fundamentals of 21 CFR Part 11, software validation, and computer system validation
David Nettleton David Nettleton
%
COMPLETE
$399
21 CFR Part 11 and Annex 11; what you need to know to pass the new regulatory inspections

Available until

Mar 15 This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted
David Nettleton David Nettleton
%
COMPLETE
$299
Statistics for Process Control

Available until

Mar 14 This seminar will provide attendees with the statistical tools necessary to monitor processes to ensure the quality of manufactured products
Elaine Eisenbeisz Elaine Eisenbeisz
%
COMPLETE
$695
Trial Master File and Clinical Data Management Regulated by FDA

Available until

Mar 15 This FDA compliance training will cover in detail the new requirements for trial master files
Carolyn Troiano Carolyn Troiano
%
COMPLETE
$199
2 Day Virtual Seminar on FDA Inspection Essentials in 2022

Available until

Mar 15-16 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
Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)

Available until

Mar 22-23 The lifecycle concept, new to these Guidance, link product and process development, qualification of the commerc
Barry A. Friedman Barry A. Friedman
%
COMPLETE
$1,295
Medical Device Process Validation Training for Professionals

Available until

Mar 22 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
%
COMPLETE
$265
Project Management Bootcamp

Available until

March 22- 23 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
%
COMPLETE
$1,495
How to write SOP's that Avoid Human Error

Available until

Mar 28 This Webinar will discuss the primary cause of quality and production losses in many industries
Ginette Collazo Ginette Collazo
%
COMPLETE
$199
Building the Project Charter, Project Scope Statement, and the Priority Matrix

Available until

Apr 13 This webinar will explain the role of each document in the project management process and their importance
Charles H. Paul Charles H. Paul
%
COMPLETE
$299
US FDA Labeling Requirements for Medical Devices

Available until

Mar 22 in This webinar, including some little known or controlled areas which are subject to regulatory scruinty
John E Lincoln John E Lincoln
%
COMPLETE
$265
All About Data Integrity by Design

Available until

April 13-14 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
%
COMPLETE
$1,295
Blockchain Innovations that Connect and Protect the Supply Chain

Available until

May 02 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
%
COMPLETE
$265
Computer System Validation for Cloud and COTS Applications–Live, Online Training

Available until

May 03-05 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
$1,495
The Project Management Plan

Available until

June 06 This webinar will introduce the concept of planning and how it is conducted. During the webinar
Charles H. Paul Charles H. Paul
%
COMPLETE
$299
Mobile Device Apps and the FDA – Classification, Regulatory Requirements and Cybersecurity

Available until

June 07 This has resulted in the FDA focusing on the subset of software functions dealing with medical issues which the Agency intends to apply its authority
John E Lincoln John E Lincoln
%
COMPLETE
$265
Determining and Managing your Project Risk – The Risk Analysis

Available until

Aug 03 This webinar will discuss project risk – how to identify it, how to quantify it, how to mitigate it, and how to prevent it from being realized
Charles H. Paul Charles H. Paul
%
COMPLETE
$299
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