Overview: The topic is 510(k) changes, a topic that is still producing more than its share of 483's and warning letters. In general, FDA does not return filings because the change described in them is not sufficiently "significant", and only rarely suggests that the traditional 510(k) should at least be scaled down to a special 510(k).Therefore, it is up to the sponsor/manufacturer to determine whether this change will be significant or not. T...

Overview: The Food and Drug Administration (FDA) was not empowered by Congress to regulate medical devices until May 28, 1976 when the Medical Device Amendments were added to the Federal Food, Drug, and Cosmetic Act (FDCA).Computer software was in a state of infancy during the 1970's and the role computer software would eventually play in the provision of healthcare was not foreseen. FDA did not have to create a software regulatory policy unti...

Overview: It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?Who Will Benefit: Validation Managers and Personnel Engineers involved in water system design and installation Utility operators...

Overview: FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last 24 months FDA issued more than 30 warning letters with citations Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems.Areas Covered in the Session: FDA's current inspection and enforcement practice...

Overview: Manufacturing involves an attempt to produce items that as closely as possible meet design specifications (e.g., size, strength, etc.). However, all production processes exhibit variation - that is, no two items are identical. What method can be used to reduce such variation? The classic and still most widely used method is called SPC or "statistical process control". SPC is a statistical tool that objectively identifies when it is w...

Overview: Every project undertaken is not a guaranteed success; there are many things that can and do go wrong. Overly optimistic budgets or underfunded projects can result in shortcuts or unrealistic pressures on those working on the project. Staff or resources lacking the skills to work on the project see the assignment as a fast track to promotion and may not be willing to admit they can not handle the project, projects escalated to be done...

Overview: Biosimilars in the US, including new regulations, existing guidelines, direction from Congress, meetings with the FDA, INDs that have been filed and NDAs that have been filed. We will also discuss the current state of affairs in Canada, who seems to be closely aligning itself with Europe.Why should you Attend: Understanding this fast developing area is critical. How will approvals be handled. Will indications be able to be bridged fr...

Overview: This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceutical Products in South Korea. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in South Korea. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and registrati...

Overview: Learn about the issues and how can they be addressed. Understand what responsibilities each of us must adopt to help ensure that our food supply is safe.Why should you Attend: This webinar will address the complexity of defining safe food and examine the factors that impact on microbiological food safety. We will look at the changing nature of foodborne/food transmitted pathogens and the influence of demographics and geography on the...

Overview: The topic starts with the communication system design that delivers the single ATCSCC facility with the radar and flight data from the entire National Airspace System (NAS) for real time processing and assessment. There is then a discussion of the various goals, strategies, and techniques the ATCSCC employs to manage and resolve areas of significant traffic congestion and delay.To draw the entire ATC series together, the webinar clos...