Tips for setting up a Quality System to withstand FDA Audits for Medical Device and Pharmaceutical Companies

05 Oct 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

CMO Supplier Quality Agreements - What you need to know to comply with new FDA & EU GMP Guidelines for contract drug manufacture

07 Oct This Webinar presentation will provide a thorough understanding of the content that is expected in Quality Agreements from a regulatory perspective.

Roger Cowan

$249

Biostatistics for the Non-Statistician

Oct 18-20, 2021 this course will have understanding of concepts and statistical methods required in pharmaceutical, biological and medical device.

Elaine Eisenbeisz

€4.665

Biostatistics for the Non-Statistician

Oct 18-20, 2021 this course will have understanding of concepts and statistical methods required in pharmaceutical, biological and medical device.

Elaine Eisenbeisz

$4,665

Calculations for Process and Product Capability

21 Oct This Webinar will focus on providing the information needed for attendees to know the appropriate measures and formulas

Elaine Eisenbeisz

$249

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

26 Oct This session will include the requirements for all of the above responsibilities, which will include defining, documenting, and implementing a complaint-

Jeff Kasoff

$199

A Comprehensive View of Medical Device Post-Market Regulations and Challenges During COVID-19— Complaint Handling, MDR Reporting and Recalls

On 21-23-Oct, 2021 this course will explain how to comply with complicated Complaint Handling, MDR and Recall requirements. Earl Bird. Register.

Rita Hoffman

€1.295

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

Oct 21 - 22 The lifecycle concept, new to these Guidances, link product and process development, qualification of the commerc

Barry A. Friedman

$1,699

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

Oct 26 - 27 The lifecycle concept, new to these Guidances, link product and process development, qualification of the commerc

Barry A. Friedman

€1.295

A Culture of Quality is a Competitive Advantage

04 Nov This webinar will help you to imbed a culture of quality throughout your organization. We will discuss concepts for creating a culture of quality

Susanne Manz

$229

Purchasing Controls and Receiving Acceptance for Medical Devices

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

Susanne Manz

$229

DHF, DMR, DHR, Technical Documentation for US FDA, ISO and EU MDR Requirements

MP3 Download This Webinar will discuss the latest U.S. FDA and European Union requirements on Design History File, and Technical File/Design Dossier

John E Lincoln

$199

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

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

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

2 Day Virtual Seminar on FDA Inspection Essentials in 2021

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

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

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

$199

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

US FDA Medical Device QSR, 21 CFR 820 and Quality Management System

MP3 Download Learn the basic overview of the original medical device Quality Management System

John E Lincoln

$229

Excel Spreadsheet Validation-Step-by-step guide to data integrity compliance in the COVID-19 Era

MP3 Download This session will make you a better Excel user, saving you time and costs

David Nettleton

$599

The FDA Inspection: Best Practices for Preparation, Behavior, and Response

MP3 Download This course provides medical device/pharmaceutical professionals with the information they need to prepare for and manage any type of FDA

Jeff Kasoff

$179

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

The European PSMF

MP3 Downoad 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

$199

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

2 Day Virtual Seminar on FDA Inspection Essentials in 2021

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

FDA Regulation of Artificial Intelligence/ Machine Learning

MP3 Download This webinar is not a programming course but will explain the present and future regulatory requirements for AI/ML

Edwin Waldbusser

$265

Building a Compliant Laboratory – From Foundation to Business Excellence

MP3 Download In this webinar speaker will define compliance, provide a translation of regulations and guidance into user requirements .

David W. Husman

$199

Power Analysis for Sample Size Calculations

MP3 Download In this webinar speaker will explain how to put the power analysis techniques to use will help to assure that you’ll collect a large enough sample

Elaine Eisenbeisz

$249

Management Review to ensure a Suitable and Effective Quality Management System

MP3 Download this course, we’ll discuss how to improve awareness, focus, and a culture of quality

Susanne Manz

$199

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

$1,095

How to write SOP's that Avoid Human Error

MP3 Download This Webinar will discuss the primary cause of quality and production losses in many industries

Ginette Collazo

$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

$287

Qualification and Control of Contract Manufacturer Organizations Based on Practical Experience

MP3 Download This webinar will cover in detail the steps to plan and conduct a program to qualify contract manufacturer organizations (CMOs)

Edwin Waldbusser

$229

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

$199

Anti-Kickback, Fraud, Stark, and Marketing - Where are the Landmines?

MP3 Download This session will benefit all functional groups who have data protection responsibility, marketing responsibilities, or need to understand

William Mack Copeland

$299