
Medical Device Process Validation Training for Professionals
John E Lincoln
90 Min
Product Id: 701662
This 90-minute session on risk-based verification and validation planning will discuss "must have" elements from the U.S. FDA cGMP, EU MDR, ICH Q9 and ISO 14971 for hazard analysis and product risk management, and show how you can integrate these into a company's quality management system.

Trial Master File and Clinical Data Management Regulated by FDA
Carolyn Troiano
60 Min
Product Id: 705360
This FDA compliance training will cover in detail the new requirements for trial master files including documents related to clinical trials that are required to be prepared, collected and maintained as part of the TMF.
Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance
David Nettleton
75 Min
Product Id: 701582
Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time.
Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
David Nettleton
90 Min
Product Id: 701687
This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).

Medical Device Change(s) and the 510(k)
John E Lincoln
90 Min
Product Id: 701742
This 90-minute webinar will provide valuable assistance to all regulated companies performing and documenting meaningful, results driven 510(k) / change analysis activities, based on the FDA's new Draft Guidance, "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", dated October 25, 2017.

Annual Current Good Manufacturing Practices (cGMP) Training
Kelly Thomas
60 Min
Product Id: 705422
This webinar provides a basic understanding and fundamental principles of Current Good Manufacturing Practices and will fulfill the requirement of personnel involved in cGMP must have documented training of current Good Manufacturing Practices. This session will focus on the FDC Act and 21 CFR federal regulations as applied to cGMP.

Human Factors/Usability Studies following ISO 62366 and the new FDA Guidance
Edwin Waldbusser
60 Min
Product Id: 704496
This training program will examine how human factors/usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. This process conforms to the new ISO 62366 standard and the new FDA guidance document.

Structuring and Conducting Risk-Based Internal cGMP Compliance Audits
John E Lincoln
90 Min
Product Id: 701432
This training will evaluate the chief areas of an FDA cGMP compliance audit and help you understand the actual and anticipated changes in emphasis based on this new regulatory climate. It will prepare you and your company for tougher US FDA cGMP compliance audits.

Powerful Closed-loop CAPA - Meeting FDA Expectations
John E Lincoln
90 Min
Product Id: 702012
This 90-minute webinar will show how you can implement a closed-loop CAPA system that meets CGMP requirements and U.S. FDA expectations. You will learn simple, but powerful, tools and methods that you can use regularly and systematically to define and resolve root causes, not just symptoms.

Project Management for FDA-Regulated Companies
John E Lincoln
90 Min
Product Id: 701758
This project management training for FDA regulated companies will show how you can meet key FDA and EU MDD regulatory requirements for the project you manage. It will focus on proven tools and techniques for successful development and implementation of project management planning.

FDA Ambitious Regulation of Social Media and Corporate Responsibility
Casper Uldriks
60 Min
Product Id: 703853
FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.

Effective Systems for Change Control in the Pharmaceutical Industry
David L Chesney
90 Min
Product Id: 705002
This webinar will help you understand GMP requirements for change control from a pharmaceutical manufacturing perspective, the purpose of change control and what types of changes are or are not subject to change control. Participants will learn how to execute and implement a change in a regulated environment.

User / Human Factors Engineering Under IEC 62366-1, -2
John E Lincoln
90 Min
Product Id: 705111
This webinar will focus on the Key parts of IEC 62366-1:2015 and -2:2016, Human Factors Engineering and Role in Design Control (21 CFR 820.30)l, Design and Development Planning (ISO 13485 7.3) .

Bacterial Endotoxin Test to Include the Latest on Low Endotoxin Recovery (LER)
Barry A Friedman
90 Min
Product Id: 705433
The webinar will review the current testing requirements as defined in the new, revised FDA guidance on Endotoxin and Pyrogen testing. It will further help attendees understand the issues surrounding the Low Endotoxin Recovery (LER) and its regulatory outcome.

Hypothesis Testing, P-values and Inference: When Thinking like a Statistician Makes Sense
Elaine Eisenbeisz
90 Min
Product Id: 703552
This clinical research webinar will explore the reasoning that formulates null hypotheses and turns researchers’ hair gray. Attendees will learn the why and how of the scientific method and how to view the world with a statistician’s eyes. Also attendees will learn the possibilities and limitations of research questions and hypothesis development, how to interpret statistical findings with p-values, effect sizes, and confidence intervals.

How FDA trains its investigators to review CAPA and what should you do to prepare
Jeff Kasoff
60 Min
Product Id: 700851
This CAPA investigation training will discuss techniques used by the FDA to review your CAPA system. You will learn what the FDA tells their inspectors to focus in the QSIT document and how your company can use the same QSIT document to prepare for inspection.

Performing Effective Management Review of the Quality System
David L Chesney
90 Min
Product Id: 704933
This webinar will teach you how to conduct an effective management review of the quality system which helps you understand how to plan and focus on right metrics and governed by an efficient process. Participants will also understand FDA policy regarding disclosure of management review information during inspections.

The FDA Inspection Process: From SOP to 483
Jeff Kasoff
60 Min
Product Id: 700269
This is a detailed course designed to provide medical device/pharmaceutical professionals with the information they need to prepare for and manage any type of FDA inspection. This course provides the rationale, strategies and flow on how to plan for an inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.

How to Use Quality Systems Inspection Technique (QSIT) to Your Advantage
Jeff Kasoff
60 Min
Product Id: 700788
This Webinar provides valuable assistance to all individuals who liaison with the FDA during inspections. It will also benefit senior management, who need to understand the methodologies used by FDA during inspections. During FDA inspections, several individuals from the organization work closely with FDA officials. For them and for senior management, understanding the intricacies of the methodologies used by the FDA is clearly of high importance.

Report Writing for Auditing Professionals
Phil Vassallo
90 Min
Product Id: 703814
Skilled auditors require a method that aligns what they experienced during the reviewing process with what they compose during the writing process. This report writing workshop will provide foundation resources that participants can continually turn to during intense, complex audit engagements.