Medical Device QMS, ISO 13485 Requirements and CAPA Regulatory Compliance Training - Live Webinars, Recordings & CDs

This training program will assist anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Professionals in the pharmaceutical, biotechnology and medical device industries who want to be Good Clinical Practices (GCP) compliant in relation to regulatory submission environment will benefit from this training. Effective and practical solutions to address real-world issues will be detailed.

This webinar on supplier controls will provide you the information you need to assure your supplier management program is in compliance with the latest FDA, European and international guidelines requiring a risk-based supplier management program. We will look at how to improve your supplier management system to meet both the FDA and ISO expectation while potentially reducing your cost of compliance.

This training program will highlight key differences between SDTM and ADaM models and process flows. It will also focus on key differences between the seven CDISC classes and on best practices to create Dataset.XML from SAS. Attendees will gain a better understanding of the structure and syntax of ODM-XML files as well.

This webinar on avoiding serious FDA 483s will explain FDA's changed audit focus based on recent top 483 findings and provide practical tips on how to better prepare your company's internal audit program to avoid serious Form 483 observations.

This Medical device training will acquaint one with the various terms used in risk management and the importance of ISO 14971 & ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture.

This webinar will review types of training requirements from the FDA and ISO 13485 for medical device employee. It will discuss techniques for monitoring and documenting training effectiveness.

This webinar will explain how to apply the theory of lean documents and its corollary theory of lean configuration to present a fresh approach to controlled document system for a life sciences manufacturing plant.

Medical Device Tracking is a very important aspect of the distribution chain of a medical device. This is because it is critical to have a mechanism by which a medical device can be traced and located in its place after it leaves the manufacturer. This system of tracking helps to identify a defective device and ensure that corrective measures are taken immediately.

This webinar will teach attendees best practices for conducting effective quality audits to ensure regulatory compliance. Learn how to avoid potential pitfalls during the audit process.

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.

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 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 explain how to create, develop and manage Design History Files (DHFs), Device Master Records (DMRs), and Design History Files (DHFs) using lean document and lean configuration methods.

Buying software is a fact of life for most companies. There is fierce competition in the market, with multiple software vendors trying to convince to buy their product. How do you determine whether to buy the software or having it built in house? Or which vendor to choose? And if you buy something, how do you determine whether to have it hosted? And are there any regulations that apply to this software? And if so, what are they?

This training program will examine how human factors/usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process and validating the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. This process conforms to the new ISO 62366 standard and the new FDA guidance document.

This webinar provides a basic understanding of the records required to fulfill requirements of both US FDA 21CFR 820 and ISO 13485:2016 for establishment and maintenance of a Device Master Record. It will further discuss the responsibilities of various development team members such as R&D/engineering, operations, quality assurance, project management and executive management.

This webinar will discuss the fundamental statistical concepts to perform an effective process validation. Attendees will learn best practices to comply with QSR and ISO 13485:2016 requirements for process validation.

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.