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

Computer System Validation Professional Certification Program 3 Days

Dec 8-10 , 2021 This course will completely immerse you in computer system validation and delivers comprehension of the regulations impacting your system

Carolyn Troiano

€1.295

Deviation Management – Why have we not solved the problem?

MP3 Download This seminar will discuss the reasons for deviation failures and provide solutions for success.

David W. Husman

$199

Marketing to Medicare or Medicaid Beneficiaries - What You Can and Cannot Do

MP3 Download This webinar will discuss the Federal Anti-Kickback Statute, what it prohibits, its penalties, its scope and its exceptions

William Mack Copeland

$199

GMP Environmental Monitoring for Pharmaceutical Clean Rooms

MP3 Download Attend this webinar to various US and international regulatory requirements, the testing requirements for the various clean room classifications

John E Lincoln

$249

Elements of a Corrective and Preventive Action (CAPA) Program and Uses of CAPA Data

MP3 Download this webinar will cover all the items listed above, and more. If you want to improve your CAPA system, you cannot afford to miss this.

Jeff Kasoff

$199

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

Quality by Design for Medical Devices Live Webinar

MP3 Download This webinar can help you create a design control process that is a competitive strength for your company.

Susanne Manz

$699

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

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

Human Factors/ Usability Studies following ISO62366 and the new FDA Guidance

MP3 Download This webinar will conforms to the new ISO 62366 standard and the new FDA Guidance document.

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

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

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

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

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

Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)

MP3 Download This course will discuss the importance of establishing metrics, how to distinguish Key Performance Indicators (KPIs)

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

Identifying Sources of Process Unreliability Within Your Organization: You May be Surprised.

MP3 Download In this Webinar you will learn how to use Reality-Charting, The Model for Improvement, and Process Reliability Modeling

David W. Husman

$209

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

Vaccine Patents in the Current Pandemic Climate Live Webinar

MP3 Download This presentation will discuss not only the global patenting issues facing vaccines but will also look at some of the challenges facing vaccine

Joanna Brougher

$199

Fired by Facebook - HIPAA and social media violations of HIPAA’s privacy requirements

MP3 Download Duration 60 Minutes

Mark Brengelman

$399

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