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

This training program will assist those responsible for planning, executing or managing the integration of a business system with any laboratory system governed by FDA regulations. On completing the program, attendees will have an understanding of laboratory system computer validation planning, execution and management concepts, and how they apply to any integrated business system.

The training program will prepare attendees to better understand the revisions to this standard as they read its requirements in detail. For those organizations that have a QMS that's compliant with ISO 13485:2003, you will benefit from this program as it will help you assess your preparations.

This webinar will cover the regulatory perspective in testing raw materials for microorganisms and how you can manage the risk of raw materials being the major source of microbial contamination in your medical product manufacturing process.

Attendees will come away from the training program with the tools they need to understand the various types of enclosures and how to select the correct type of enclosure for their process in order to meet regulations, protect the product, and ensure worker safety. The course is apt for personnel in FDA regulated industries who want to learn about what enclosure is best suited for their process and why.

This training program will dispel mistaken paradigms regarding the risk based approach to water system lifecycle. It will detail how to eliminate variability – the cause of most deviations. Attendees will learn how to capitalize on the advantages of online analytical instrumentation (chemical and microbiological rapid methods).

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 It will help attendees stay updated with the current trends set out by the amendments to the guideline and help them draft guidance documents that will impact their business.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 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 course will instruct attendees on establishing an approach to process control within each unit of operation to generate overall process control needed for validation. The webinar instructor, an FDA expert, will enumerate the importance of variation in enhancing a validated means of operation and the parameters that can cause variability. The Randomized Block statistical model will also be analyzed for effective validation.

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 explain how to incorporate a quality system into the validation process to reduce cost and ensure compliance. It will cover the analysis, design and initiation phases, including full implementation of the incorporation.

This webinar will explain how to generate a practical and compliant methodology to handle equipment requalification. Attendees will learn about common pitfalls to avoid when requalifying equipment.

This webinar will explain the regulatory path of an in vitro diagnostic (IVD) and Laboratory Developed Test (LDT). It will discuss the CLIA regulations for Laboratory Developed Tests (LDTs), including companion diagnostics (CDx) and how these differ from the FDA’s authority.

This webinar on outsourcing medical device manufacturing will discuss practical decision making steps you can follow to analyze whether to transfer or invest in keeping production in-house. If you decide to transfer production, then this training will detail the options and next steps to transferring it to the right facility or contract manufacturer.

This webinar on objectionable microorganisms will show how to identify and prevent objectionable microorganisms that are beyond the ones outlined in USP <1111>. Attendees will learn the clinical implications due to presence of objectionable microorganisms.

This ISO 13485 requirements training will provide guidance to medical device companies in developing an adequate Quality Management System (QMS) in accordance with ISO 13485 and FDA expectations. This webinar will also benefit medical device companies that are planning to market their products in Europe.

This medical device process validation training will use recent warning letters to explain the regulatory requirements for process validation and what FDA Investigators look for. It will cover process validation components (IQ, OQ, and PQ), and the content of protocols and reports.

This webinar on sterilizing grade filter validation will describe the essential requirements and steps for process validation of sterilizing grade filters. It will discuss multiple guidance documents in regard to sterilizing grade filtration and their interpretation.

This 90-minute webinar on personnel practices and microbial control in Pharmaceutical, Biotech, and Medical Device manufacturing will cover effective ways to train personnel on gowning and personnel practices in cleanroom operations to limit contamination. This webinar will also address controlling microorganisms on process equipment and product contact surfaces.

This Sterilization validation training will review the general requirements for validation as described in ISO 11137:2006.

In this Cleaning validation training we will discuss preparing the cleaning validation protocol. Important aspects such as how to set acceptance criteria and how to measure cleanliness will then be reviewed.