Medical Device Audits and Inspections Training - Live Webinars, Recordings & CDs

This training program will discuss key terms and responsibilities related to FDA inspections and the purpose of the BIMO inspection program. It will also review the general purpose and overall process of an FDA inspection and enhance your inspection preparation strategies.

This training program will provide attendees with the ultimate set of tools in order to help their firms properly create User Requirement Specifications (URS) for Computer Systems Validation (CSV) with emphasis on current industry trends in this particular area as well as current Food and Drug Administration (FDA) regulatory trends and enforcement activity.

This 90-minute webinar will review FDA's draft regulations for UDI and describe the new requirements for labeling medical devices. It covers the new regulations in 21 CFR Part 830, the changes to Part 820, the Quality System Regulation; Part 801, Labeling; Part 803, Medical Device Reporting; Part 806 Corrections and Removals; and other regulations.

This training program will enumerate the inspection process for API, drug and device manufacturers and summarize recent changes. It will guide attendees on preparing staff for the new FDA inspections and discuss the role of exit meeting to avoid enforcement.

This webinar will review FDA’s regulations related to suppliers in manufacture of drugs, biologics and medical devices. It will discuss the current regulations, guidance documents and best practices for supplier management and enforceable quality agreement using case studies for a variety of scenarios. Common FDA audit findings will be discussed.

The webinar will focus on the amendments made to the Blue Book Memorandum #G95-1 Use of International Standards ISO-10993, “Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.” It will help attendees stay updated with the current trends set out by the amendments to the guideline and help them draft guidance documents that will impact their business.

This training program will discuss why it is important for you to be better aware of and to become better acquainted with FDA inspection best practices. In particular, the webinar will detail a list of Dos and Don’ts before, during and after the inspection.

This webinar will teach attendees how to prepare for, manage, and follow up on FDA inspections. It will discuss common pitfalls to avoid during an inspection.

This webinar will help attendees understand the FDA and EU inspection process and how to prepare for both of them. Attendees will learn the best practices to respond to Form 483 citations, Warning Letters and EU inspection findings.

This FDA compliance webinar will discuss in detail the guidance on recognition and use of consensus standards. It will focus on the topics such as voluntary conformance, declaration review and content of declaration of conformity.

This webinar will focus on the current trends in FDA inspections and guidelines that can be implemented to ensure compliance with the latest quality and regulatory requirements. Attendees will learn how to prepare for an FDA inspection to avoid Warning Letters.

This webinar will discuss requirements for supplier and vendor qualifications. Attendees will learn how to develop a risk management plan for monitoring of suppliers, vendors and service providers. It will also discuss how to prevent recalls and advisory notices due to provided non-conforming materials or bad services.

This training will outline the possible consequences for failing to promptly and adequately correct significant violations related to cGMPs, new drugs or devices, labeling or other regulatory issues resulting in advisory, administrative and judicial actions.

This webinar will discuss FDA's requirements for medical device supplier management and the controls you need to have in place to ensure compliance with quality. It will cover how to structure a supplier quality agreement and the tools and methods you need for evaluating and assessing suppliers.

This FDA audit training provides an overview of the audit readiness process from internal evaluation of your quality systems to the logistics of the audit itself; with key emphasis placed on equipping you and your team with the skills needed to present expert testimony during interviews with regulators.

This virtual seminar will start by evaluating important areas for regulated companies to focus in 2013-2014, based on the U.S. FDA’s recent "Strategic Priorities" initiative. The second-half of the session will discuss how FDA's global initiatives affect supplier chain management and vendor audits and how you can prepare to address them.

This webinar on handling FDA inspectors will discuss practical tips to cope with a difficult FDA compliance officer or inspector. You will learn how to wiggle out of complicated situations, make legal arguments and challenges to the FDA agent and use meeting requests and other tools to ease tensions.

This webinar on preparing for FDA inspections will present simple but powerful tools, with real world examples on how to prepare for an impending FDA inspection. You will learn what essential last minute preparation activities can be done and others that should be avoided.

This 120-minute webinar will help medical device manufacturers to understand what you need to do to ensure that your process, the methods, and the procedures that you have established to implement the requirements for design controls are in perfect order.

Attendees will receive a detailed understanding of process validation for medical devices approach employing IQ, OQ, and PQ. You will learn the information to include in the protocols and reports, the role of Statistical Process Control (SPC), using Design of Experiments (DOE), attribute sampling plans as a verification method, and a discussion of the GHTF document on process validation.

Understanding the GHTF guidance document is particularly important, since FDA (CDRH) plans to issue it as a guidance document in FY2011.