Medical Device Supply Chain and Manufacturing Regulatory Compliance Training - Live Webinars, Recordings & CDs

This webinar, by an ex-FDA, will cover Good Data Integrity Practice for GxP environments. Participants will understand what FDA looks for with regard to data integrity, what may need to be audited, the new guidance and application of data integrity, and relevant regulations for data integrity

This webinar will discuss best practices for preparing for an international announced inspection as well as how to be always prepared for those in the US who may be inspected at any time. It also discusses the various roles of the persons who will be assisting during the inspection and suggests how to organize support personnel to aid in keeping the inspection going smoothly and identify and address issues before FDA sees them.

The course is designed to review critical elements of the new regulations and will be run as an interactive 2 hour course designed for business leaders with a good working knowledge of current requirements.

This webinar will teach attendees best practices for building a sustainable vendor qualification program for FDA regulated industries. It will discuss common pitfalls to avoid when qualifying vendors.

This training will provide an understanding of graphical tools used to identify multiple populations or failure modes. Attendees will learn how to estimate product reliability for multiple populations using Minitab® v17.

This webinar examines the issues in audit sampling and provides the answers one need to plan audit. It will help attendees understand the use of standard sampling plans in an audit including FDA’s QSIT sampling plans.

This webinar on sterility or bioburden test for medical devices will discuss about the various items that should be investigated to determine the root cause, when a failure occurs during a sterility test, and the follow up to the investigation.

The Medical Device Classification webinar explains the classification system in US and the EU.

This webinar explains what it means to be “normally distributed”, how to assess normality, how to test for normality, and how to transform non-normal data into normal data.

This webinar will provide an overview of mobile medical apps and discuss when the app becomes the FDA regulated medical device. It will also discuss the cybersecurity requirements for mobile apps.

This webinar will cover all relevant regulatory requirements (CFR, FDA, ISO, ASTM and European) for establishing the stability and determining the shelf-life of medical devices. Attendees will gain a better understanding of the design control process for designing medical devices.

This webinar will cover FDA’s current thinking on QRM and Guidance for Industry - Q9 Quality Risk Management, provide information to help understanding of QRM concepts, and applications. In addition, brief review of how ICH Q8, Q9, and Q10 work in coherence throughout product lifecycle.

Attend this webinar to increase one’s knowledge of FDA inspections, what inspectors are looking for and expect to see and not to see in manufacturing facilities. It will provide an in-depth understanding of how to prepare for unannounced FDA audits and inspections.

This webinar will focus on the recent changes to the ISO 9001 and ISO 13485 quality management system (QMS) standards. Participants will be provided with the tools necessary to help their company plan for the transition to the new editions.

This webinar will cover in detail the steps to plan and conduct a program to qualify contract manufacturer organizations (CMOs). It will teach best practices to meet regulatory requirements and satisfy practical needs to obtain the best CMO.

To provide a clear understanding on impact the EU Commission Recommendation has had on tighter controls, roles and further responsibilities of Notified Bodies and other changes, which will impact manufacturers and their corresponding suppliers. As a result, this webinar furnishes details on how can these latter parties prepare for a Notified Body routine surveillance and unannounced audits. Advance preparation and planning to these changes and others, will help you have a smoother transition to what is expected and required. This webinar will also provide the challenges and benefits of successful results from Notified Body routine and unannounced audits.

This webinar will explain how to use ANSI/ASQ Z1.4 to define sampling plans including its switching rules. It will also offer an inspection plan format that reduces the sequential sampling plan to ten or fewer rows in most cases.

This device compliance training will offer a basic understanding of the records required to fulfill requirements of both US FDA 21 CFR 820 and ISO 13485:2016 for establishment and maintenance of a Design History File (DHF). It will also help attendees understand what document control means for DHF records.

This webinar will cover US FDA and Customs legal import requirements including discussion on FDA product codes, Custom's Harmonized Tariff Schedule (HTS) and Affirmation of Compliance (AOC). It will also provide information on FDA's software screening program, PREDICT, and U.S. Custom's ACE program.

This webinar will provide valuable assistance to all regulated companies; a CAPA program is a requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.