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Product image for 2 Day Virtual Seminar on FDA Inspection Essentials in 2022

2 Day Virtual Seminar on FDA Inspection Essentials in 2022

MP3 Download This seminar, you will learn how to properly alert key members that an investigator has arrived, the proper protocol

Course•By Danielle DeLucy

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Product image for 2 Day Virtual Seminar on REACH and RoHS Compliance: Protecting Revenues with Advanced Compliance

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

Course•By Kelly Eisenhardt

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Product image for 3 Hours Virtual Seminar on Successful Deviation Investigations

3 Hours Virtual Seminar on Successful Deviation Investigations

MP3 Download Duration 180 Minutes

Course•By Danielle DeLucy

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Product image for 3 Hrs Virtual Webinar on Aseptic Processing and Validation

3 Hrs Virtual Webinar on Aseptic Processing and Validation

MP3 Download This course will provide an overview of requirements for aseptic and bulk manufacturing operations, including facility design and contamination

Course•By Kelly Thomas

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Product image for 3 Hrs Webinar on What You Need to Know: Investigating Out-of-Specification (OOS)

3 Hrs Webinar on What You Need to Know: Investigating Out-of-Specification (OOS)

MP3 Download This webinar will review the regulatory requirements for investigating an OOS Investigation.

Course•By Danielle DeLucy

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Product image for 3Hour Virtual Seminar on IEC 62304 and Demystifying Software Validation using the Principles of LDLC

3Hour Virtual Seminar on IEC 62304 and Demystifying Software Validation using the Principles of LDLC

MP3 Download This session will give you a good understanding of how the IEC 62304 differs from ISO 13485. It will also cover components of the Software

Course•By Jose Mora

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Product image for 4 Hours Training Course on Medical Device Cybersecurity and FDA Compliance

4 Hours Training Course on Medical Device Cybersecurity and FDA Compliance

This webinar will focus on cybersecurity of medical devices

Course•By Carolyn Troiano

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Product image for 6-Hour Virtual Seminar on eCTD Submissions of IND/NDA to the US FDA, EU and Canada

6-Hour Virtual Seminar on eCTD Submissions of IND/NDA to the US FDA, EU and Canada

On Demand Webinar Duration 360 minutes

Course•By Peggy J. Berry

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Product image for 21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

MP3 Download This seminar will help you understand in detail the application of FDA’s 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations

Course•By Carolyn Troiano

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Product image for 21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

MP3 Download This webinar will cover the key aspects of complying with 21 CFR Part 11 in both validating systems and maintaining them in a validated state throughout their entire life cycle.

Course•By Carolyn Troiano

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Product image for 21 CFR Part 11 - Compliance for Electronic Records and Signatures

21 CFR Part 11 - Compliance for Electronic Records and Signatures

MP3 Download This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security

Course•By Edwin Waldbusser

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Product image for 21 CFR Part 11 and Annex 11; what you need to know to pass the new regulatory inspections

21 CFR Part 11 and Annex 11; what you need to know to pass the new regulatory inspections

describes exactly what is required for compliance with Part 11

Course•By David Nettleton

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Product image for 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

MP3 Download The attendee will learn a simple way to address both data integrity and Part 11 aspects of the system, focusing on risk and critical thinking

Course•By Carolyn Troiano

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Product image for 21 CFR Part 11 Compliance for SaaS/Cloud Application

21 CFR Part 11 Compliance for SaaS/Cloud Application

MP3 Download This course benefits anyone that uses computer systems to perform their job functions and is ideal for professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors

Course•By David Nettleton

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Product image for 2024 Human Error Prevention & GMP Masterclass

2024 Human Error Prevention & GMP Masterclass

Latest FDA Regulatory Requirements & Most Common GMP Issues Caused by Human Error

Course•By Ginette Collazo

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Product image for 2024 Human Error Prevention & GMP Training Course - New

2024 Human Error Prevention & GMP Training Course - New

MP3 Download this training would provide tools that can be implemented and used after this event.

Course•By Ginette Collazo

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Product image for 2024 Toxic Substance Control act (TSCA) Basics

2024 Toxic Substance Control act (TSCA) Basics

MP3 Download This is a one (1) day training course on the Toxic Substance Control Act and the latest developments for 2023

Course•By Kelly Eisenhardt

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Product image for EU MDR Implementation and Transitioning to the Deadline: Essential Tasks to Complete

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

Course•By Kelly Thomas

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Product image for Advanced Pharmacovigilance Auditing and Inspections Virtual Live Training Course

Advanced Pharmacovigilance Auditing and Inspections Virtual Live Training Course

MP3 Download Pharmacovigilance Auditing Inspection course will explain how to prepare for the audit

Course•By Michael Ramcharan

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Product image for AI in Drug Discovery: Aligning with FDA's Latest Risk-Based Framework

AI in Drug Discovery: Aligning with FDA's Latest Risk-Based Framework

MP3 Download The use of Generitive AI in the Drug discovery and Development Process. The US FDA's encouragement of AI technology in pharma development and clinicals - their risk-based framework.

Course•By John E Lincoln

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Product image for All About Data Integrity by Design

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

Course•By Carolyn Troiano

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Product image for An Advanced Course on Lean Documents, Lean Configuration, and Document Control

An Advanced Course on Lean Documents, Lean Configuration, and Document Control

MP3 Download Duration 90 Minutes

Course•By Jose Mora

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Product image for Analytical Method Validation Under Good Laboratory Practices (GLPs)

Analytical Method Validation Under Good Laboratory Practices (GLPs)

MP3 Download Duration 60 Minutes

Course•By John C. Fetzer

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Product image for Analytical Methods Validation for FDA Compliance

Analytical Methods Validation for FDA Compliance

Jan 14-15 In this course, general guideline for the determination of the analytical

Course•By Kelly Thomas

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Product image for Analytical Methods, Process, Equipment, Cleaning, and Sterilization Validation

Analytical Methods, Process, Equipment, Cleaning, and Sterilization Validation

MP3 Download Both the U.S. FDA and EU's MDR expect documented risk-based device test method and design V&V under the GLPs, et al

Course•By John E Lincoln

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Product image for Annual Product Quality Reviews; Preparation & Reports - FDA, EU, & Canada Regulatory Requirements

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).

Course•By John G. Lanese

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Product image for Annual Product Quality Reviews; Preparation & Reports - FDA, EU, & Canada Regulatory Requirements an

Annual Product Quality Reviews; Preparation & Reports - FDA, EU, & Canada Regulatory Requirements an

On Demand Webinar Duration 120 minutes

Course•By John G. Lanese

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Product image for Applying Computer System Validation To Mobile Applications

Applying Computer System Validation To Mobile Applications

On Demand Webinar Duration 60 minutes

Course•By Carolyn Troiano

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Product image for Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products 2 Day Course

Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products 2 Day Course

Dec 11-12 The objective of this live, interactive WCS training seminar is to explore the role of aseptic filling to assure that manufactured product

Course•By Barry A. Friedman

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Product image for Aseptic Technique and Cleanroom Behavior – Avoiding Human Error

Aseptic Technique and Cleanroom Behavior – Avoiding Human Error

MP3 Download this course we will review how quality systems helps in defining requirements for cleanrooms

Course•By Danielle DeLucy

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Product image for Audit Trails - Critical to Support FDA 21 CFR Part 11 and Data Integrity Compliance

Audit Trails - Critical to Support FDA 21 CFR Part 11 and Data Integrity Compliance

MP3 Download You’ll learn an approach to both 21 CFR Part 11 and data integrity compliance understanding what FDA expects stakeholders in industry to do. There a few simple suggestions that can streamline validation activities related to all of these key areas.

Course•By Carolyn Troiano

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Product image for Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach

Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach

MP3 Download This eight-hour vendor qualification audit training will help you improve

Course•By Kelly Thomas

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Product image for Avoid Warning Letters in View of the U.S. FDA's Stated Goal

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.

Course•By John E Lincoln

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Product image for Basic GMP Training for the QC Laboratory

Basic GMP Training for the QC Laboratory

MP3 Download This course will provide participants with an understanding of how to effectively handle out-of-specification

Course•By Kelly Thomas

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Product image for Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA

Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA

MP3 Download Duration 90 Minutes

Course•By Carolyn Troiano

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Product image for Best Practices for Deviation Training

Best Practices for Deviation Training

MP3 Download -Duration 180 Minutes

Course•By Danielle DeLucy

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Product image for Best Practices for Equipment Validation, Tracking, Calibration, and Preventive Maintenance

Best Practices for Equipment Validation, Tracking, Calibration, and Preventive Maintenance

MP3 Download This training will provide valuable assistance in process development include in Equipment Validation, Tracking, Calibration, and Preventive

Course•By Carolyn Troiano

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Product image for Best Practices To Help You Pass An FDA Computer System Validation Audit

Best Practices To Help You Pass An FDA Computer System Validation Audit

MP3 Download Duration 90 Minutes

Course•By Carolyn Troiano

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Product image for Biostatistics for the Non-Statistician

Biostatistics for the Non-Statistician

Sep 16-18 this course will have understanding of concepts and statistical methods required in pharmaceutical, biological and medical device.

Course•By Elaine Eisenbeisz

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Product image for Biostatistics for the Non-Statistician

Biostatistics for the Non-Statistician

MP3 Download this course will have understanding of concepts and statistical methods required in pharmaceutical, biological and medical device.

Course•By Elaine Eisenbeisz

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Product image for Building GMP Excellence: A Guide to Implementing Compliant Training Programs

Building GMP Excellence: A Guide to Implementing Compliant Training Programs

MP3 Download The session discussed GMP regulations, agency expectations, training program responsibilities, new employee requirements, transferred employees, external service providers, events, skills qualification program, assessment, retraining, instructor qualifications, curriculum, documentation, and performance deviations.

Course•By Ginette Collazo

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Product image for CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations

CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations

MP3 Download Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations

Course•By John E Lincoln

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Product image for CAPA: Definition, Plan and Program

CAPA: Definition, Plan and Program

MP3 Download Duration 90 Minutes

Course•By Danielle DeLucy

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Product image for cGMP Regulatory Inspections - Through the Eyes of FDA, EMA and PMDA

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 object

Course•By Kelly Thomas

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Product image for Changes to 21 CFR 820 - Device QSR to QMSR - Due February 02, 2026

Changes to 21 CFR 820 - Device QSR to QMSR - Due February 02, 2026

MP3 Download This webinar will discuss what the new QMSR will require, by including a discussion of the Final Rule and its Preamble

Course•By John E Lincoln

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Product image for Cleanroom Fundamentals - Regulation, Science, Design, Practice, Operation & Management

Cleanroom Fundamentals - Regulation, Science, Design, Practice, Operation & Management

MP3 Download This webinar will discuss the ISO-defined and classified cleanroom (especially US FDA-regulated) to include its systems for establishing

Course•By John E Lincoln

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Product image for Clinical Data Management Training

Clinical Data Management Training

MP3 Download Duration 2 Day

Course•By Elaine Eisenbeisz

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Product image for Compliant Management Controls Under 21 CFR 820 and ISO 13485

Compliant Management Controls Under 21 CFR 820 and ISO 13485

MP3 Download Best QSR and ISO 13485 requirements webinar for management controls, Organizational structure and Establishment of an internal audit program.

Course•By Jeff Kasoff

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Product image for Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Product

Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Product

MP3 Download In this course, you will learn the practical applications for ensuring regulatory compliance as required by FDA regulations

Course•By Karl M. Nobert

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Product image for Computer System Validation ( CSV) 3 Day Seminar

Computer System Validation ( CSV) 3 Day Seminar

Dec 09 - 11 3 day CSV course will teach you how to comply with key FDA and international CSV

Course•By Carolyn Troiano

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Product image for Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall

Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall

MP3 Download Duration 90 Minutes

Course•By Carolyn Troiano

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Product image for Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software

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

Course•By Carolyn Troiano

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Product image for Computer System Validation (CSV) vs. Computer Software Assurance (CSA): Following a Waterfall vs. Agile Methodology

Computer System Validation (CSV) vs. Computer Software Assurance (CSA): Following a Waterfall vs. Agile Methodology

MP3 Download The attendee will learn about FDA’s approach to modernizing technology, and how that will benefit both the Agency and industry.

Course•By Carolyn Troiano

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Product image for Computer System Validation for Cloud and COTS Applications–Live, Online Training

Computer System Validation for Cloud and COTS Applications–Live, Online Training

MP3 Download The attendee will learn about FDA’s approach to modernizing technology, and how that will benefit both the Agency and industry

Course•By Carolyn Troiano

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