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

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 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 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.

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.

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 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.

This medical device training program will provide an understanding of creative methodologies to solve design and development challenges of connected solutions for patient monitoring, scheduling, tracking, or drug delivery. It will demonstrate how consumer technologies vary by level of complexity and how they can be used in healthcare.

This webinar will provide an understanding of the organizational hierarchy of FDA and Health Canada, your regulatory and quality compliance obligations and the implications of the interactions between these two agencies on your organization.

This training program will provide an understanding of key areas of design focus for medical wearables. Attendees will learn best practices to implement product development plan that apply to medical devices.

Many companies offer their devices in the EU, so must comply with the EU UDI regulations. There are significant differences from the US system. While some details remain, there is sufficient information to allow companies to start planning. This webinar can help you prepare for this major aspect of the new EU regulations.

This training program will discuss changes from ISO 13485: 2003 to ISO 13485: 2016. Attendees will learn how to apply additional supplier controls and understand how improvement and corrective action clauses are strengthened.

Medical device manufacturers need systems to implement regulatory requirements (meeting customer requirements and handling regulatory complaints) as well as a business processes to determine customer satisfaction. While the three systems are related, each serves a different purpose. You will learn how to implement a customer satisfaction process to complete theses three important aspects.

When exporting outside the U.S., exporters must consider the Food and Drug Administration (FDA) provisions as it helps them understand what documents and procedures are needed in coordination with the transaction process. This training program will provide an in-depth explanation of FDA-regulated products that are exported from the United States to foreign countries. Also, it will address what export documentation must be used in the transportation of FDA-regulated products.

This 90-minute webinar will cover general considerations for microbial control for non-sterile manufacturing areas, including attributes of an effective cleaning and disinfection program. Points to consider specifically aimed at oral solid dose (OSD) manufacturers will also be presented, including cleaning and disinfection of both product contact and non-product contact surfaces.

Analyzing processes to understand their operation and implementing improvement is a necessary element in any quality system, but is especially important in medical devices. One of the more important tools is linear regression. Using Excel, you can get the information you need for process improvement.

This webinar will provide the basic understanding of how to conduct a compliant and effective out-of-specification (OOS) result investigation which is critical in preventing product recalls, voluntary and involuntary plant shut down, and FDA 483 findings or warning letter. It will also provide a basic mainframe for the Quality Assurance unit in the final disposition of the affected finished product as well as provide guidance for the different types of OOS investigational systems.

This course will describe the basic principles and requirements for building a supplier audit program. This webinar will provide a framework on which to build your subcontractor auditing program.