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: The Microbiology Lab must take leadership in contamination control support for production because it is the hub of the necessary technical expertise. This broad manufacturing support role covers many areas, including routine raw material and product testing, disinfectant/sanitant qualification, water and compressed gas testing, environmental monitoring, microbiological “awareness training” of production operators, etc. Perhaps their most difficult leadership role is in contamination control investigations where product is at risk, manufacturing may be at a standstill, and the pressure to resume operation with a quick (and possibly incorrect) fix is tremendous. In these situations, the microbiology lab can either gain…

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…

Overview: This webinar teaches how to determine and document risk in a process in order to reduce validation time and ensure compliance. What makes this session unique are the real life examples that make application of the techniques understandable in the context of any validation project. It includes a workshop for participants to perform their own hazard analysis so they are proficient in applying the risk-based techniques. Areas Covered in the Session: Interactive real life examples. How to identify risk and establish mitigations. How to use the hazard analysis to make validation efficient. How to document the risk assessment using…

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…

STEM talent is indeed global and skills must be sourced worldwide. Companies will need visibility into where skills are located and access to them to overcome location mismatch, the challenge of STEM talent not residing where it is needed. Utilizing both traditional labor market intermediaries (staffing agencies, job boards) and emerging intermediaries to reach talent will be vital. This conference will focus on how organizations can recruit, develop and retain the STEM talent needed to excel in the 21st century. Representatives of industry, higher education and government are encouraged to attend and set a course for aligning our nation’s workforce…

From the Creators of Call Center Week: Taking Call Center Performance, Productivity & Metrics to the Next Level Gone are the days were contact centers simply answered and responded to calls. Call centers are taking on an increasing strategic role and must strive to enhance customer experience while increasing sales and reducing operating costs. Join Call Center Performance and Productivity & Metrics, September 12-14 in Dallas, Texas and learn how to turn your call center into a profit center. Experience how to create a well-integrated operation across tools like workforce management, coaching, e-learning, performance management, speech analytics and surveys. Plus:…

The inaugural HR Excellence Summit brings together 100+ cross-industry leaders in the field of HR across the Americas to discuss the most pressing human resource issues facing the industry. With a focus on investigating and advancing current and future trends, this summit is a must attend for senior HR Executives looking to make a real impact on their organizations. It is an opportunity for the most senior thinkers and practitioners in the HR community to come together to share experiences, make new contacts and benchmark with their peers. The 2012 event agenda features interactive discussions around: • Integration of HR…

The 1st International Conference on Cultural Psychiatry in Mediterranean Countries is a highly anticipated and ambitious event that seeks to deal with novel issues appearing in a world of open frontiers, new opportunities and international upheaval and conflicts, particularly relevant in light of recent events in the region.

La conference internationale de la langue française est un grand rassemblement auquel tous 200 participants, particulierement des enseignants, répresentant du gouvernement, organisations non gouvernementales, entreprises, individus, universitaires ou tous autres acteurs de la société civile partageront leurs craintes, ambitions, idées et leurs experiences sur la langue francaise. Cette conference est un moment fort, de témoignages, de débats et d’activités créatives, au cours duquel les participants seront conviés pendant 5 jours à se prononcer sur les avantages et inconvenients de la langue francaise dans les domaines économique, éducatif, culturel. La conference incitera des participants attendus de tous les continents à des…

Séminaire international sur Les Changements climatiques mondiaux Ce séminaire est un grand rassemblement qui va réunir du 10 au 14 septembre 2012 à Toronto, ON de 9AM à 3PM plusieurs dizaines de participants particulièrement des experts, étudiants, des chercheurs, répresentants des gouvernements, délégations des organisations non gouvernementales et individus venant de tous les coins du monde. L’objectif principal de ce séminaire est de rappeler aux participants les notions climatiques de chaque continent et de présenter les principaux mécanismes responsables des variations du climat à différentes échelles de temps. Les orateurs vont faire le point sur les connaissances actuelles relatives aux…

Course Description:- Implementing an effective system for corrective action and preventive action can be a major challenge. FDA illustrates the point in its published information on Warning Letters. FDA cited the CAPA subsystem in 81 of 89, 91%, of Warning Letters issued in 2010, the most recently available data. The CAPA subsystem includes nonconforming material, corrective and preventive action, and complaints (820.90, 820.100, 820.198). The trend continues in recent warning letters. This interactive two-day course provides the tools you need to develop and implement an effective medical device CAPA system. In addition to FDA QSR, the course covers the corresponding…

Course Description :- Most medical devices marketed in the European Union must follow the Medical Device Directive (MDD); IVD device and active implantable devices have other directives. The MDD can be complicated, especially for US companies, because the MDD’s approach is different than the regulatory approach in the US. For example, under the MDD your company makes “submissions” to a private company that you hire, not to a government agency. This interactive two-day course will help you comprehensively understand details of the MDD and implement its requirements. Attendees will learn how to classify devices, select the appropriate conformity assessment path,…

Course Description:- Knowing how to get your 510(k) application through FDA quickly can save millions of dollars in unnecessary investment burn. Mark DuVal, a national authority on the 510(k) program is in Silver Spring, Maryland at FDA nearly twice a month negotiating 510(k)/IDE/PMA issues for his clients. He will teach you the basics and advanced knowledge of the 510(k) program. He will also provide insights in what FDA looks for in 510(k) submission and common mistakes companies make in drafting 510(k)s. This will include insights and commentary on CDRH’s new proposals for the 510(k) program. He will also discuss the…

Course Description :- Nearly every computerized system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated. Finding efficiencies without weakening the quality position is essential. This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments.Attendees learn how to decrease software implementation times and lower costs using a 10-step risk-based approach to computer system validation. The instructor addresses the latest computer system industry standards for data security, data transfer,and audit trails. Students see how 21 CFR Part 11, the FDA regulation pertaining to use…

Course Approach:- This interactive Risk seminar will provide attendees with enhanced risk assessment skills that go beyond COSO and RCSAs. This seminar will improve your understanding of key risks and allow you to more effectively communicate risks to senior management. In this program we will explore the role of leadership, technology, and the decision sciences play in creating the right environment for business performance and risk management to co-exist. Course Description:- In today’s competitive business environment risk management programs must be cost effective, demonstrate business acumen, and add value to organizational goals. Regardless of whether you are using Microsoft spreadsheets…

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…

Course Description: This 2-day on-site Course will help you gain a comprehensive understanding of the Regulatory Structure, Clinical Trial Requirements and the Conduct of Running Clinical Research in Japan and South Korea. It will prepare you for the regulatory approval processes, Agency meetings, the complexities of running studies in both countries, the importance of partner selection and the cultural knowledge needed for success. The recent changes made by PMDA and KFDA to be more sponsor-friendly will be reviewed. Real world experiences on actual interactions with the Agencies since these changes, will also be discussed. Who will Benefit: This course will…

Course Description :- All pharmaceutical, biologics, and medical device facilities are likely to have high purity water systems. In spite of this purity, microorganisms can flourish within these systems and lead to undesirable contamination of facility processes and their products. Of all the individuals at the facility who should understand the microorganisms in water systems and how best to monitor and control and them, it should be the site’s microbiologists. Sadly, this is often not the case due to the lack of familiarity with biofilm and its impact on water system sampling, testing, sanitization, and routine maintenance. This course is…