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

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

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

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

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

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

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

Annual Current Good Manufacturing Practices (cGMP) Training

MP3 Download This webinar provides a basic understanding and fundamental principles of Current Good Manufacturing Practices and will fulfill the requirement

Kelly Thomas

$229

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

Computer System Validation Boot Camp®

The course moves quickly and participants will change gears often to keep interest high and accommodate multiple learning styles

Carolyn Troiano

€2.800

The Veterinary Drug Approval Process and FDA Regulatory Oversight

MP3 Download This two-day seminar will provide attendees with an understanding of FDA’s veterinary drug approval process, obtaining federal government

Karl M. Nobert

€1.295

FDA’s Ambitious Regulation of Social Media - New Course By FDA Investigator

MP3 Download This webinar teach us about social media platforms provide common ways to cross FDA’s legal boundaries for “misbranding” your product

Casper (Cap) Uldriks

$229

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

Hypothesis Testing, p-values, and Inference: When Thinking Like a Statistician Makes Sense

MP3 Download You will learn the why and how of the scientific method, and how to view the world with a statistician’s eyes

Elaine Eisenbeisz

$499

FDA Inspections – Proven Preparation & Survival Techniques : What Regulators Expect and How to Prepare

MP3 Download This seminar will help you use the FDA inspection as a learning tool, not as a negative or adversarial experience.

Danielle DeLucy

$3,995

Data Integrity: FDA, WHO and EMA's Requirements

MP3 Download This two day seminar is to explore and define the necessary elements in the development and implementation of a Data Integrity program

Barry A. Friedman

$1,495

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

FDA’s Plan to Modernize the 510(k) Pathway: What Regulatory, Quality and Compliance Professionals Need to Know

MP3 Download This webinar will discuss the 510(k) framework to reflect advances in device technology, safety and capabilities, making it harder to obtain

John E Lincoln

$287

Multiplicity: When and How to Adjust for Multiple Testing

MP3 Download this webinar will explain the differences between family wise error rate (FWER) and false discovery rate (FDR).

Elaine Eisenbeisz

$249

Medical Device Cybersecurity and FDA Compliance

MP3 Download This webinar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products

Carolyn Troiano

$695

Audits in the World of COVID-19 and Beyond: Are You Ready for Remote Audits?

MP3 Download The presentation will provide an insight and guidance to managers with QA departments to implement a Remote Auditing program

Michael Ramcharan

$229