In the highly regulated medical device world, standards and regulations are continuously evolving to ensure that the highest levels of quality and safety are achieved. To that end, international regulators have long recognized the value of developing a standardized, global approach to auditing and monitoring medical device manufacturing, and for the last five years, the International Medical Device Regulators Forum (IMDRF) has spearheaded an effort to create such a framework.
In the highly regulated medical device world, standards and regulations continue to evolve to ensure that maximum levels of quality and safety are achieved. This includes the advent of unannounced audit visits from notified bodies.
In the highly regulated medical device world, most manufacturers have to manage different types of quality system audits in order to comply with many international regulations, which creates a huge burden on staff and budgets. Through this course, you will be able to benchmark your audit processes in order to improve the efficiency and quality of your audits.
In the highly regulated medical device world, standards and regulations are continuously evolving to ensure that the highest levels of quality and safety are achieved. Through this course you will be able to assess your existing quality system processes and understand the changes that will need to be implemented in your organization to comply with the revised ISO 13485 Standard and to meet expectations from notified bodies.
Sponsors of clinical trials – and organizations that execute clinical trials – consistently identify the need for well trained and qualified people at all levels to execute studies. Fast-paced clinical trials and the pressures to quickly and effectively meet project milestones can be overwhelming.
Recent statistics show that human error is the cause of nearly 80% of failures in manufacturing facilities. This poses a tremendous challenge to pharmaceutical, biotech, and medical device companies as it translates to a significant loss of time, money, and consumer confidence each year.
Data integrity is absolutely critical to the quality and efficacy of finished pharmaceutical products. Pharmaceuticals manufactured without accurate, trustworthy data cost firms millions in fines, lost sales, and general lack of brand confidence.
In this webinar you will learn how to avoid costly mistakes and, more importantly, discover creative ways to use the medical device classification system to your competitive advantage. Simply put, the more effective your classification strategy, the quicker and easier you will get your products to market while making it more difficult for your competitors at the same time –the true art of regulatory strategy.
Standard operating procedures (SOPs) are a fact of life in regulated industry. They are a critical part of almost every aspect of product production in the life sciences, and are therefore some of the most heavily scrutinized documents during regulatory audits and inspections.
In this webinar you will learn how to design the substantial equivalence component of a successful 510k submission to get a medical device to market as quickly and efficiently as possible and to avoid problems before they occur.
This unique seminar demonstrates important regulatory requirements and concepts using case study discussions of real products from a variety of clinical specialities. Strategies for using regulation as a competitive advantage will also be discussed.
As medical devices become more complex and expensive, reprocessing becomes more attractive, and mitigating risks is critical. This session will give you the tools you need to tackle those challenges.
