This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application. What makes this session unique is the combination of step-by-step instructions and the hands on workings of each participant. Bring your laptop and use Excel for your own needs. This session will make you a better Excel user, saving you time and costs. Areas Covered in the Session: * Develop spreadsheet applications that are GxP compliant. * Avoid 483s and warning letters. * What does and does not need to be validated. * Learn…

The National Congress of Cardiology is one of the key events on the scientific calendar in Bulgaria bringing together more than 1300 participants from all over the country and eminent foreign specialists. For the first time this year the program of the Congress will include joint session between the European and Bulgarian Societies of Cardiology. Leading international lecturers are invited. For more information: http://cim.bg/index.php/en/view/organizing-XII-national-congress-cardiology/

Cell banking assures that an adequate supply of equivalent well-characterized cells exist for production over the expected lifetime of the biopharmaceutical. Cell line development followed by preparation of the master/working cell banks is an expensive process and needs to be done right the first time. Cell banks acceptable for early clinical trial material production have been found not to be adequate and appropriate for commercial production, causing product approval delays and rejections. Why should you attend: 'Secret', according to Merriam-Webster's dictionary, is 'something kept hidden or unexplained.' A variety of reasons why an effective Chemistry Manufacturing & Controls (CMC) regulatory…

As the purpose of a clinical trial is to determine safety and effectiveness of a treatment, it is imperative that the rules of the trial be followed exactly. If there are Instances of "Protocol Not Followed" (PNF), that could result in a failure to determine safety and effectiveness. That is why eligibility criteria are so strict, and why any PNF or unexpected events need to be reported immediately. Principal investigators in clinical trials are expected to adhere to the study protocol. Instances of “Protocol Not Followed” (PNF) are not addressed in the CFR or other regulatory rules. The various terms…

This clinical evaluation & ISO 14971 training will discuss how the new changes in MDD and the risk management requirements per 14971 overlap and how manufacturers can establish one integrated system to meet both the requirements. Why Should You Attend: The changes to the Medical Device Directive (MDD) should be in place by now. However, many manufacturers didn't recognize the March 21, 2010 was the final date for compliance, rather than the start of the transition period. One of the new requirements has the device manufacturer update the clinical evaluation (and its documentation) with data obtained from the post-market surveillance.…

This Data Monitoring Committees (DMC) webinar will guide you through the essential and the purpose of the Data and Safety monitoring plan. Areas Covered in the Seminar: - The historical background of why Data and Safety monitoring is essential. - The purpose of the Data and Safety monitoring plan. - The Regulatory requirements for safety monitoring. - Studies requiring a formal Safety Monitoring Committees. - What does the "Charter" of a DMC compose of? - What is the composition and function of a DMC? - What types of studies "require" a DMC? - Conflict of interest and the DMC. Who…

This three hour overview of financial risk management will provide the fundamentals to risk management that all managers need to comprehend. Regardless of job titles, risk management is a shared responsibility by all managers. Compared to accounting, risk is an immature discipline with a variety of risk frameworks competing to dominate. Based on the new Wiley and Sons book, Essentials of Risk Management, due for publication at the end of 2010, this webinar is designed to provide a non-math introduction to an area and discipline that is changing rapidly, especially in the light of the risk management failures that have…

Document control can be a time- and paper-consuming process. Even the simplest of changes often requires an inordinate amount of time spent in the preparation, submission, distribution, and implementation of change requests, document modifications, document review meetings, document approvals, and document placement. Many companies can spend MUCH LESS time and prepare MANY LESS documents, and still be in compliance with the regulations. This presentation will review the QSR and ISO requirements for document control, and provide a streamlined process for document control. Records maintenance, distribution, and management can be similarly streamlined by this system. Areas Covered in the Session: *…

Drug companies face many challenges in pediatric clinical research. Pediatric trials come with a high level of complexity and cost. In order for professionals to carry out a successful pediatric drug development plan, they need the right infrastructure and information to avoid obstacles such as slow recruitment, noncompliance and difficulties in developing the right study criteria and protocol. When conducting research on children, drug companies must ensure that ethical boundaries are observed in both the design and execution of pediatric trials. Attend this Webinar to understand the ethical, economic, regulatory and technical considerations when conducting clinical studies on children. Discussions…

This one-of-kind webinar is intended to provide you with practical guidelines on applying SLA concepts to your organization's GRC program. Organizations that have SLAs for GRC reap these benefits: * Ongoing improvements in their ability to identify, assess and prioritize risks * facilitates business owners involvement in risk management and GRC programs that affect them * Better communication on risks to stakeholders * Measurement criteria on GRC actions and a basis for ongoing improvement What You will Learn from the Webinar: * Receive a clear picture of the current view of GRC * Obtain a clear knowledge of SLA concepts…

This webinar will describe European PV requirements, including compliance with applicable laws, regulations and guidance. In addition, attendees will learn how to compare the company's PV operations to applicable best practices in Europe. Why should you attend: Large and small pharmaceutical companies face an increasingly complex set of international regulations in their commitment to patient safety and Good Pharmacovigilance Practices. The regulatory framework in Europe presents complex challenges to meeting international requirements effectively. Areas Covered in the Session: * International Conference on Harmonization (ICH) * Regulatory Framework * European Medicines Evaluation Agency (EMEA) * Eudravigilance * Electronic submission of ICSRs…

This Sterilization validation training will review the general requirements for validation as described in ISO 11137:2006. Areas Covered in the seminar: - General requirements of ISO 11137:2006, Method 1 and VDmax25, to include (but not limited to): .Pre-validation activities and requirements. .Product bioburden testing and analysis. .Laboratory methods and practices. .Analysis of verification dose results. .Basics components of protocol and final report. For More Details: http://bit.ly/9Gb0dZ

The FDA has proposed an overhaul of the 510(k) clearance system In its release of reports from two working groups, the FDA's goals are to increase the predictability and transparency of the 510(k) process and enhance FDA scientific decision-making. It will also increase the burdens on industry. For example, if finalized, there will be a new subclass of Class 2 products for which clinical studies will be required. You will learn of possible changes in the de novo process that could streamline the clearance process. There will be new definitions of "Substantial Equivalence" and "intended Use" will be redefined and…

This Medical Device Quality System training will discuss how to Create an adequate quality system that meets FDA’s requirements and Effectively prepare for upcoming Quality System Regulation (QSR) inspections. Why Should You Attend: Your newly approved device is now on the market and is undergoing mass production at your manufacturing facility. What’s next? Now, you as device manufacturer are subject to an additional set of FDA requirements known as Quality System Regulations (QSR) and FDA can schedule an inspection at any time. Quality System inspections, to the unprepared, can be seen as an overwhelming and intimidating experience; however, understanding the…

This (QSR) Quality System Regulation webinar describes management responsibility by reviewing the Quality System Regulation (QSR) and the reasoning that FDA published. It covers each of the components of management responsibility and provides a list of things you should consider in your implementation. Why Should You Attend: One of the most common areas for FDA Warning Letters is Management Responsibility. FDA considers this a principal subsystem and is where they start inspections. Ensuring that you understand what they expect and how to implement it is a valuable approach to preventing problems. This webinar examines the requirements for management responsibility using…

This adverse event reporting Webinar/training will discuss the clinical trial regulations requirements with respect to adverse event and explain how to assess and report AEs and SAEs. Areas Covered in the seminar: The CFR definitions of Adverse Events, Serious Adverse Events, Unanticipated Adverse Device Effects and many more. How to know what an Adverse Event is and when to report it or them. Understanding laboratory AEs and the "Reference Range" concept. Type A and Type B Adverse Reactions. Common Mistakes in AE / SAE Reporting. Reporting of Adverse Events - when and to whom and the use of Adverse Event.…

This change control webinar will discuss the change control activities and documentation required to meet GMP requirements Areas Covered in the Seminar: - Defining a "change" and "change control". - Tougher FDA Expectations / Requirements. - Areas impacted. - FDA "Hot Buttons". - Design Control. - Document Control; Archiving. - Identifying "changes". - Preventing negative changes and entropy. - Maintain a ‘state of control’. Who Will Benefit: This information applies to personnel / companies in the Pharmaceutical, Medical Device, Diagnostic, Neutraceutical and Biologics fields. The employees who will benefit include: - Senior management - Regulatory affairs - Quality Assurance /…

The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point". This is a major headache. How can companies make that determination? How can they trigger such an analysis over the major change or the series of smaller changes. What approaches are required for product changes; for process changes. How is the process risk-based? How to maximize the process against…

As your company's system continues to grow, the potential for "crisis issues" to occur grows proportionally. The concern for food safety to your customers and employees must be a constant area of focus for all operators in the system. Ultimately, how well your company manages the crisis situations it will make a significant difference in how your company brand is perceived in the public's eyes and how well it succeeds in today's highly competitive marketplace. Most important is that failure to ensure food safety can jeopardize the health of your customers and could be detrimental to your business and reputation.…

The 6th Annual World Healthcare Innovation and Technology Congress (WHIT v.6.0) is the leading event for senior executives tasked with making multi-million dollar strategic, organizational and IT decisions to position their organizations for success in the rapidly changing marketplace. WHIT v.6.0 brings together providers, payers, government officials and other key stakeholders to provide critical insight and leading-edge case studies on innovative technologies and strategies that will improve outcomes and minimize costs. ** Confirmed speakers include FIVE speakers whose organizations have reached Stage 6 or above on the HIMSS EMR Adoption Model(sm) and SIX speakers from H&HN's 2009 Health Care's 100…