Cybersecurity - US FDA Requirements – New Course !

MP3 Download This webinar will consider how cybersecurity is introduced into the CGMPs, design control (21 CFR 820.30) for devices, and post-production

John E Lincoln

$249

Purchasing Controls, Receiving Inspection, and Supplier Audit – what to do during a global pandemic

MP3 Download This webinar will provide insights into how to use remote auditing techniques to minimize the risk and maximize the benefits of conducting audits

Susanne Manz

$249

Analytical Method Validation and Transfer

MP3 Download This course will provide a thorough review of regulatory guidelines on method validation and transfer

Kelly Thomas

$229

Device Changes, FDA Changes, and the 510(k)

MP3 Download In this webinar you will learn What approaches are required for product changes; for process changes

John E Lincoln

$199

Human Error Solutions: How we reduced 60% of human errors in less than a year, a Case

MP3 Download Join this session by expert speaker Ginette Collazo, where she will discuss how by redesigning the training function and by focusing on the expected result

Ginette Collazo

$249

Introduction to Medical Device Quality System Regulations

MP3 Download Attendees will learn FDA’s expectations for the implementation and on-going operation of an effective medical device

Paul Larocque

$265

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

Preventing Human Error in the Life Sciences Virtual Seminar (4 hours)

MP3 Download This four hour virtual seminar, will explore the true causes and nature of human error, how human error should be investigated

Charles H. Paul

$2,995

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

Essentials of Validation - IQ, OQ, PQ

MP3 Download This course will cover the validation essentials for medical device manufacturers

Susanne Manz

$179

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

Assessment of Drug-drug Interactions in Drug Development

MP3 Download The topics that will be discussed during the webinar include the investigation of CYP enzyme- and transporter-mediated drug interactions

Dr. Stefano Persiani

$199

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

Carolyn Troiano

$1,495

Transfer Of Methodology

MP3 Download Even a detailed and well-written standard operating procedure for a method cannot ensure that 2 laboratories

John C. Fetzer

$189

Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices

MP3 Download The seminar will provide attendees with a better understanding of responsibilities and gain a greater knowledge of the issues faced

David R. Dills

$1,299

Good Documentation Practices

MP3 Download This presentation will discuss the purpose of good documentation, what proper documentation looks like and a brief discussion of elements

David W. Husman

$199

Purchasing Controls and Receiving Acceptance for Medical Devices

MP3 Download This webinar can help you understand your responsibilities in terms of Purchasing Controls enabling you to provide safe and effective products

Susanne Manz

$229

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

MP3 Download 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

$199

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

Lyophilization Basics for Pharmaceuticals: Scale-Up, Validation, Deviations

MP3 Download This course will provide an overview of the process, and suggest approaches that may be considered

Lisa Hardwick Thompson

$299

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

Biomarkers in Drug Discovery and Development

MP3 Download The topics that will be discussed potential benefits of a biomarker in drug development are very significant

Dr. Stefano Persiani

$199

Production and Process Controls for Medical Devices What You Need to Know

MP3 Download This webinar can help you prevent serious issues such as these. You’ll learn about FDA quality system regulation expectations, and how you can

Susanne Manz

$249

Investigation of Out-of-Specification Test Results

MP3 Download Attendees will learn the FDA expectations when investigating out-of-specification and out-of-trend laboratory results.

Paul Larocque

$265

The European PSMF

MP3 Download This course teaches you with evolution of the PSMF and the legislation concerning it for the EU, sections of the PSMF, annexes of the PSMF

Graeme Ladds

$249

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

Technical Writing for professionals in the life sciences

MP3 Download This virtual seminar will walk you through the technical writing process from start to finish. Each critical aspect of writing technical documents

Charles H. Paul

$1,495

Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions Virtual Training

MP3 Download The objective of this FIVE HOUR/DAY, ON-LINE two day interactive seminar is to explore raw materials and their requirements – issues and solutions.

Barry A. Friedman

€1.895

Verification and Validation - Product, Equipment / Process, Software, QMS+

MP3 Download This seminar will provide valuable assistance to all regulated companies that need to review and modify their Master Validation Planning and Plan(s).

John E Lincoln

$1,295

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

Write it Right – Standard Operating Procedures

MP3 Download This webinar will help you to write complete, clear, unambiguous, and flexible SOPs.

Susanne Manz

$487

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

Complaint Management: Best Practices to Assure Regulatory Compliance and Customer Retention

MP3 Download This session will include the requirements for all of the above responsibilities, which will include defining, documenting, and implementing

Jeff Kasoff

$249

Writing Excellent SOPs Webinar

MP3 Download You will learn techniques for creating concise and easy to read SOPs that your employees can understand and will follow

Susanne Manz

$179

Purchasing Controls, Supplier Management, and Receiving Acceptance for Medical Devices

MP3 Download This 2-day virtual seminar can help you understand your responsibilities in terms of Purchasing Controls enabling you to provide safe

Susanne Manz

$1,295