Medical Device Regulatory Compliance Training - Live Webinars, Recordings & CDs

This webinar will provide an overview of the FDA expectations in medical device industries for setting up a quality system for FDA audit readiness. It will also provide an understanding of the quality system inspection techniques (QSIT) requirements for documents controls, production and process controls, packaging and labeling controls and more.

This webinar will focus on "non-traditional" medical device markets, challenges to market access including competitors and government regulation or lack thereof. Outside of the most developed countries, there are many areas in the world, not as developed, where registration and marketing of medical devices is extremely lucrative. These include: Latin America (LATAM), Asia Pacific (APAC), and The Middle East (EMEA).

This session will focus on conducting a risk/benefit analysis of both the positive and potential negative impact of the advancement of AI and ML devices in the medical device industry. It will provide a further understanding of the FDA's current thinking on the implementation of regulatory policies to ensure safe and effective medical devices that advance the quality of life of the patient. Artificial intelligence technology is rapidly spreading across the medical field, as systems are being developed that can identify signs of illness and disease in a wide variety of imaging situations such as MRI and CT. AI devices are complex with respect to algorithm used in their development, information being input in to the systems in which they learn, and the recommended out from such learning.

This webinar pulls together current US FDA and UK MHRA guidance covering medical devices and diagnostic tests during the current COVID-19 emergency. Particular emphasis will be given to ventilators and other respiratory aids within the medical device topic.

This webinar will discuss the multi-faceted aspects of bringing a medical device to market. The webinar explores topics ranging from market concept to post-market surveillance. Entering a medical device market involves more than engineering and regulatory compliance. Companies need to consider a variety of issues to successfully enter the medical device market.

Attend this webinar to learn about the new EU legal requirements for exporting medical devices to the EU. Learn how to prepare for this MDR requirement and include options for selling your device in the EU and the U.S.

This training program will provide the regulatory requirements (US) for complaint handling in the medical device and pharmaceutical industries. The course will touch on complaint sources, and details will be furnished on the interrelationships regarding complaint handling/change control/adverse event reporting/and recalls. The course will also include timeline requirements associated to adverse event reporting, which reporting formats to use, when to recall and types of recalls.

This webinar will demonstrate methodologies for obtaining competitor information to use for the establishment of equivalence. You will also learn how to monitor changes in the global regulatory medical device landscape.

In this webinar attendees will learn how to develop, use and document Hazard Analysis and the Product Risk Management File and Report per ISO 14971:2007/12 and ICH Q9. Also a field-tested (US FDA and EU Notified Body) multi-industry “model” will be presented in detail.

This webinar will help you understand specific product verification and validation requirements for medical devices to comply with ISO 13485: 2016 and FDA quality system regulations. It will focus on the topics such as product development process, traceability and risk management at all stages, design outputs and documentation in DMR and DHR, design verification and design validation activity cycles and more.

Internal audit should be an essential guide to corrective and preventive action and drive improvement. But it doesn’t always work that way. In this webinar, we’ll cover the reasons internal audit doesn’t work and how you can correct that. This webinar will explore how to improve your internal audit program so it is the efficient and effective tool it is meant to be. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to identify areas of non-compliance and quality risks. A well-designed audit program can be an effective tool in understanding, communicating, and reducing quality and compliance risk.

This webinar provides attendees with an introduction to FDA Import Alerts and what they are, examine why they are issued, show you where to locate them and how to determine whether a company or product is on one, and finally, provide strategic recommendations for removal from an alert.

This webinar will cover the new paradigms for designing safe products. It will discuss how to plan for Zero Defects at little or no cost resulting in high return on investment. It will cover real industry examples from the instructor’s experience.

This webinar will help you better understand test method validations to verify the performance of a Medical Device, global reference standards, the FDA requirements and how to perform successful TMV to ensure your inspection of verification is effective, using detailed real-life case studies.

Attend this webinar to understand the new requirements of the medical devices regulation EU IVDR 2017/746 in the European Union and get ready to receive the new certificates until May 2022.

This webinar will discuss in detail the methods of sterilization to be used on medical devices and pharmaceutical products including advantages and disadvantages of each method. Also attendees will understand the regulations pertaining to sterilization of products that will help to decide with method to use for their product. Validation of each sterilization method will be discussed and how best to prove to a regulatory body the products being treated are considered sterile.

This training program will cover statistical hypothesis testing concepts including: null and alternate hypotheses, test statistics, p-values, confidence intervals, confidence levels, power, power curves, and sample sizes. Several types of hypothesis tests will be covered such as 1 and 2-sample means tests, tests of variances, and tests of proportions. Equivalence tests will also be discussed. The importance of selecting appropriate sample sizes will be stressed.

Attend this webinar to learn how to set up and use kanbans, JIT, pull system, and drum-buffer-rope in medical device and biotechnology manufacturing start-up operations. Also attendees will learn elements of lean documents and lean configuration, sterilization lot size, MRP II kanban system and how to use kanbans to track off-site sterilization and external supply chain suppliers.

This webinar will discuss main differences between current EU Medical Device Directive (MDD) 93/42/EEC and new EU Medical Device Regulation (MDR) 2017-745 and how to ensure compliance with the new MDR requirements that will be mandatory starting May-2020.