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Inspection and Audit Readiness Training for Medical Device Manufacturers
John E Lincoln
90 Min
Product Id: 706877
This webinar will focus on how to prepare domestic and foreign medical device manufacturers selling to the U.S. to recognize and prepare for FDA pre- and post-market inspections.
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Combination Product Device Supplier Management Training
John E Lincoln
90 Min
Product Id: 706876
The U.S. FDA continues to increase its requirements for tighter control and management of vendors / suppliers / outsourcing. Combination products doubles the problems. And Covid 19 has compounded supply chain issues.
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Conducting Remote Medical Device QMS Audits Training
John E Lincoln
90 Min
Product Id: 706875
Remote QMS-CGMP compliance inspections are here to stay. Add it to your toolbox for vendor and remote site audits, especially for low to moderate risk companies.
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Computer System Validation and Part 11 Compliance
Joy McElroy
60 Min
Product Id: 705427
This webinar will discuss in detail the requirements of 21 CFR part 11 and updated European Annex 11 regulation including requirements for local, SaaS, and cloud hosting. It will also offer techniques to implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds.
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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.
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Medical Device Non-Product Software Validation Training
John E Lincoln
90 Min
Product Id: 706874
This presentation focuses on the verification and validation planning and execution of software, used in medical device manufacturing, after basic developmental testing and de-bug. It includes COTS (commercial off-the-shelf), custom, and the growing field of "cloud"-based software. A suggested FDA model (mandated for submissions) will be evaluated, implemented, with V&V documentation and test case examples. The focus is on the most recent issues the FDA has had in this area, and remediation approaches. Software considered: 1) Production / Test, and 2) QMS / 21 CFR Pt. 11, and 3) Cybersecurity / Networked systems. Examples will be demonstrated. Evaluation of the chief areas of FDA concerns will focus on actual and anticipated changes in emphasis based on the changing regulatory climate.
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US FDA Labeling Requirements for Medical Devices
John E Lincoln
90 Min
Product Id: 706873
The definition of labels is well defined and ususally well known; "labeling" not so well. Differing requirements for different applications can be confusing and are the subject of this webinar.
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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.
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Validation Sampling Plans
Alan M Golden
60 Min
Product Id: 706332
This webinar will discuss setting up statistically justified sampling plans for process validation. Discussion will also involve using the sampling plan to set acceptance criteria for process validation. Setting acceptance criteria for test method validation will also be presented.
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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.
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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.
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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.
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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) .
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Post Market Surveillance with the new Medical Device Regulation EU MDR 745/2017
Frank Stein
90 Min
Product Id: 706121
This webinar will help you understand the requirements of the new medical device regulation EU MDR 745/2017 and teach you how to create new required reports for the Notified Body and the Competent Authorities and how this process is connected to other processes in the quality management system according EN ISO 13485:2021.
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Medical Device Registration and Regulatory Submissions Know How for RA Professionals - Training Bundle
Daniel O Leary,Mercedes Massana,Cheryl Wagoner
11 Hrs
Product Id: 706835
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Project Management for Medical Device Regulatory Affairs - Training Bundle
John E Lincoln,Edwin L Bills,David Dills
6 Hrs
Product Id: 706834
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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.
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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.
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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.
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ANDA Submission and GDUFA Guidance
Charles H Paul
60 Min
Product Id: 706791
An ANDA is an Abbreviated New Drug Application. This application is submitted to the FDA to seek approval to produce a U.S. generic drug from an existing patented approved drug. The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs. After approval, the applicant is able to produce and market the generic drug product.