Courses

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

$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

$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

$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

$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

$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

$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

$199

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

$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

$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

$3,999

Quality Systems Inspection Technique (QSIT), and How to use it to Your Advantage

MP3 Download This Webinar provides valuable assistance to all individuals who liaison with the FDA during inspections. It will also benefit senior management

Jeff Kasoff

$249

How FDA trains its investigators to review CAPA and what should you do to prepare

MP3 Download This webinar will discuss all the documents used by FDA to train their inspectors to review your CAPA system, some of which you may not be familiar

Jeff Kasoff

$249

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.

Carolyn Troiano

$499

FDA's Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices

MP3 Download The objective of this live training webinar is to explore the NEW/REVISED Guidances for Industry on Pyrogen and Endotoxins Testing. FDA Training

Barry A. Friedman

$249

Risk Based Verification and/or Validation to meet US FDA CGMP and ISO 13485 Requirements

MP3 Download This Webinar will provide valuable assistance to all regulated companies that need to review and modify their Master Validation Planning.

John E Lincoln

$199

Full Day Virtual Workshop Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Syst

MP3 Download This webinar will aim at understanding and scoping out various phases of Qualification activities that will be integrated

Joy L. McElroy

$695

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.

Danielle DeLucy

$399

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

Danielle DeLucy

€1.295

What You Need to Know: Auditing EU-MDR and EU-IVDR Implementation

MP3 DowIoad this webinar you will learn about Auditing EU-MDR and EU-IVDR Implementation. We’ll share insights on the importance of good project management

David R. Dills

$399

Pharmaceutical Compressed Air Quality GMP Requirements - What you need to know to meet FDA and Inte

MP3 Download This webinar will give you an understanding of the different types of contamination inherent in compressed air

Roger Cowan

$199

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

Kelly Thomas

$299

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

Jose Mora

$399

4 Hours Training Course on Medical Device Cybersecurity and FDA Compliance

This webinar will focus on cybersecurity of medical devices

Carolyn Troiano

$695

Data Integrity and Data Governance for Computer Systems Regulated by FDA

MP3 Download This webinar will help you understand in detail the application of FDA’s guidelines for Computer System Validation

Carolyn Troiano

$240

Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program

MP3 Download This course will give an introduction into the Medical Device Single Audit Program (MDSAP) and how to adjust your internal audit program

Frank Stein

$429

Risk-Based Approach to Part 11 Compliance and Policies and Procedures to Support GxPs

MP3 Download This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle

Carolyn Troiano

$392

Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines

MP3 Download This 2-day seminar will explain the new Analytical Procedure Lifecycle guidelines and give attendees the knowledge needed to implement recommend

Kelly Thomas

€1.295

Establishing a Robust Data Integrity Program

MP3 Download This webinar will detail a data integrity governance program and principles for defining quality and data integrity into processes and systems.

Kelly Thomas

$199

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

Carolyn Troiano

$179

FDA CDS Software Regulation:The Latest Guidance on Clinical Decision Support Software

MP3 Download This Webinar will discuss clinical decision support (CDS) software might be regulated as a medical device.

John E Lincoln

$199

Best Practices for Deviation Training

MP3 Download -Duration 180 Minutes

Danielle DeLucy

$399

Dealing with CAPA- Corrective and Preventive Actions in FDA Regulated Industries

MP3 Download New Root Cause Analysis Techniques and CAPA Management live webinar is for those in Operations, Facilities , Engineering and QA/QC

Meena Chettiar

$179

Managing Risk Within Your Supplier Management Program Live Webinar

MP3 Download In this webinar, we will unpack the latest FDA requirements for supplier quality assurance (SQA)

Tim Fischer

$299

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.

Jeff Kasoff

$179

FDA’s Plan for Modernizing the 510(k) Pathway

MP3 Download This FDA Training online will explain Basic of US FDA’s Expectations for the 510(k), The Medical Device Safety Action Plan and 510(k)

John E Lincoln

$179

Is My Data Abnormal? Normality Tests and Transformations Live Webinar

MP3 Download In this webinar, you will also learn tools and concepts to understand what makes a distribution normal and when a transformation of data

Elaine Eisenbeisz

$299

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

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: 1

$1,295

Pharmacovigilance Certification

Pharmacovigilance Online Courses & Certifications

Courses: 2

$3,995