Overview: In the area of product design, one of the most critical and least understood phases is Design Validation at the interface with Process Validation. The international standard on medical device Risk Management impacts this phase through a requirement for verification of risk control effectiveness. In order to accomplish Design Validation, Process Validation must be partially completed. In order to complete Design Validation, regulators expect Risk Management to be completed. This presentation will discuss this critical interface between these three elements and give medical device manufacturers practical advice on implementation of a process that meets the requirements of all three…

This 90-minute webinar will discuss the new FDA "Global Engagement" Initiative for new areas for heightened CGMP compliance from U. S. FDA-regulated companies and their global partners. It will cover areas for increased awareness, focus, and remediation, and the approaches that are now mandated. Why Should You Attend:- The last two years have seen major initiatives at the FDA; as well as prominent drug and device failures over cGMP issues, resulting in recalls, lawsuits, class action lawsuits, and even possible criminal prosecution. The FDA sees globalization as a growing reality, and potential contributor of major regulatory issues: the supply chain,…

Overview: Each lecture will be 90 min in length. There will be morning and afternoon breaks of 30 min each which will be reduced to 15 min, if needed to accommodate long lectures. Lunch will be at least 1 hr in length. The instructor will be available for questions and discussions during all breaks and lunches and will also be available for a minimum of 30 min at the end of each day. The first day’s presentations will be for those who are new to the U.S. regulations. The second day’s presentations will be aimed at people in Regulatory Affairs…

Overview: This course will present, in one place, the regulations and guidelines that apply to early phase products. In some cases these will not be regulations, but needs that, if met, will increase the efficiency of activities as a product proceeds through the development process. The course will present these items in the order of product development from the point of R & D activities to the completion of Phase 2 clinical trials. Why should you attend: Any pharmaceutical worker who must deal with products both in early and latter phases of development should attend this course in order to…

Course Description :- Sterilization is a critical aspect of device approval and release. Though this is indeed fact, manufacturers sterilize product as a matter of course, without expert sterilization assurance personnel to guide them through potential problems in sterilization. As the world and meaning of CAPA continue to evolve in the medical device industry, further misunderstanding arises when faced with determine root cause and corrective (or preventive) action for any variation in this critical process in device manufacture. The course will begin with an overview of EO sterilization, explaining which aspects of the process often cause confusion. This will be…

‘Imprinting the Future’ We have learnt from the last two decades that the period covering conception, pregnancy and early infancy is unique in life, as a number of stimuli, not only insults or diseases, have long lasting effects and shape the whole life of an individual. Health and disease, but also less explored issues such as behavior or senescence are involved in developmental ‘programming’. Early exposure to imbalanced nutrition and lifestyle, stress, or toxic chemicals, starting as soon as in the pre- periconceptional periods, can act silently with effects revealed only at (late) adulthood. In this framework, epigenetic, transgenerational mechanisms…

Overview: The U.S. Food and Drug Administration issued the final rule establishing regulations to require current good manufacturing practices (CGMPs) for dietary supplements. The current good manufacturing practices (CGMPs) final rule will require that proper controls are in place for dietary supplements so that they are processed in a consistent manner, and meet quality standards. The CGMPs apply to all domestic and foreign companies that manufacture, package, label or hold dietary supplements, including those involved with the activities of testing, quality control, packaging and labeling, and distributing them in the U.S. The rule establishes CGMPs for industry-wide use that are…

"Teens Using Drugs: What To Know and What To Do" is a free, ongoing, two-part series designed to help participants learn to understand, identify and address adolescent alcohol/other drug problems. Part 1 provides information on how to understand and recognize the signs of a teen substance abuse problem and includes a short video. Part 2 provides information on what should and should not be done when a teen substance abuse problem is recognized, and concludes with a short open talk by a young person in recovery. The series is presented on the first (part 1) and second (part 2) Tuesday…

Overview: This webinar will cover the various methods used to determine residual moisture in products ranging from bulk powders, to sterile freeze-died products in vials, to foods. Understanding the different techniques, their limitations, and proper execution will result in more accurate and precise moisture results, which translates into better quality products with longer shelf lives. Why you should attend: Monitoring and controlling residual moisture in powders, lyophilized solids, foods, etc can be a critical factor in achieving and maintaining quality products throughout their expected shelf life. Improper levels of moisture in products can result in poor powder flow properties, spoilage,…

Overview: Major postmarketing vigilance revisions are now in force. A revised medical device guidance document on postmarketing vigilance (MEDDEV 2.12-1 rev 5) came into force on January 1, 2008. Providing more guidance than the previous version, the new document includes new reporting terminology and concepts such as "periodic summary reporting" and "trend reporting." In addition, the terms "advisory notice," "near incident," and "recall" have been eliminated or replaced. Although MEDDEVs are not legally binding, it is likely that all European Competent Authorities will follow the new guidelines and will expect organizations involved in the management and reporting of adverse incidents…

Overview: The top management of a company is responsible for ensuring that all regulatory requirements are met. This concept is codified in both the QSR and ISO 13485. FDA officials have repeatedly stated that the management controls subsystem is the central subsystem because it is the "glue that holds the quality system together." Since it is individuals in top management that the FDA will typically seek to fine or prosecute in the event of major noncompliance, this session is key for those individuals who are members of top management, or those regulatory professionals who need to understand these requirements to…

It’s a great pleasure to invite you to the “Cadmium Symposium 2012”, that will take place in Sassari (Sardinia) Italy, from 8 to 9 June 2012. Cadmium is a heavy metal with a high toxicity. It is toxic at very low dose and it has acute and chronic effects on human health and a high impact on environment. The meeting, that will include a wide spectrum of presentation covering the main aspects of cadmium biology as well as its clinical implications, is divided into three main sessions: Cadmium and Environment (Subtopics: Epidemiology; Food Chain) Cadmium and Cell Biology Cadmium, Cancer…

Overview: This CAPA training program helps you to understand, in 10 easy steps, the entire CAPA process. It includes elements of Quality Tools, Team Effectiveness, Awards & Recognitions, and Verification & Validation of actions taken. Attend this webinar to grasp the A to Z of CAPA and learn how to implement & manage it for success. Why Should You Attend: We have found out, through auditing many organizations world-wide that the organizations are pretty good when it comes to corrective actions yet they are not nearly as good when it comes to the preventive actions. This webinar should provide you…

Antibody drugs play a more and more significant role in biopharmaceutical industry around the world. Over $50 billion dollars sales in the world market, it keeps a rapid growth with the speed over 20 percent per year. The ballooning of antibody shows that: with the rapid development of science and technology, antibody must be the hot in the next decade. With the profound influence of previous Pharma manufacturing summit, based in Shanghai China Antibody China Summit 2012 is about to become one of the most influential international summit. We would like to be committed to the prosperity of industry and…

This 90-minute presentation will cover the FDA Quality System Requirements for software used in medical devices. The presenter will review FDA guidelines on software verification and validation and discuss methods to verify and validate even complex software. Why Should You Attend:- Software problems are now the third-leading cause for recalls of medical devices. Most recalls are because of incorrect verification and validation for safety. Most of the knowledge on how to do a comprehensive V&V is not widely understood. Software design is a complex set of interactions within the device, with the connecting devices, and with users of the device.…

Overview: The FDA's Quality System Regulation (QSR) prescribes the Quality Management System for a medical device manufacturer who markets in the US. ISO 13485 covers the rest of the world. The webinar describes management responsibility by reviewing the regulations and the reasoning that FDA published. Management responsibility, in QSR, has five major components: Quality Policy, Organization, Management Review, Quality Planning, and Quality System Procedures. The webinar covers each of these topics 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.…

Overview: This webinar is not a project management certification course. It is designed to provide the tools necessary to assist those designing a result or deliverable to achieve that end. It will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale. Three of the most common tools will be discussed. Common variants such as "dashboards" will also be presented. A very simple approach using common Excel- or Word-type PC applications programs that…

"Teens Using Drugs: What To Know and What To Do" is a free, ongoing, two-part series designed to help participants learn to understand, identify and address adolescent alcohol/other drug problems. Part 1 provides information on how to understand and recognize the signs of a teen substance abuse problem and includes a short video. Part 2 provides information on what should and should not be done when a teen substance abuse problem is recognized, and concludes with a short open talk by a young person in recovery. The series is presented on the first (part 1) and second (part 2) Tuesday…

Overview: Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted. This presentation will discuss what advance preparation is needed on the part of the auditor, and discuss what the auditor should look for during the audit. Since documentation is often an issue, a discussion of documentation problems will be…

Overview: Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted. This presentation will discuss what advance preparation is needed on the part of the auditor, and discuss what the auditor should look for during the audit. Since documentation is often an issue, a discussion of documentation problems will be…