The US FDA receives over 100,000 reports a year of medical device adverse events including deaths, serious injuries, and malfunctions. Because of this high number of reports, the FDA sought ways to sort the data using hierarchical coding systems that included a device problems code; a manufacturer’s evaluation for the event: methods, result, and conclusion; and also information on the patient and the device..
This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa. The programme will cover the regulatory requirements and developments in the individual countries such as Algeria, Bahrain, Egypt, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE, and Yem..
Standard Operating Procedures and work instructions – the documentation required by regulation – is essential to the effective and compliant running of any regulated business. Unfortunately, many individuals in those businesses miss the valuable opportunities that properly developed Standard Operating Procedures/Work Instructions can provide. Regulated documentation can serve a variety of purposes other tha..
One of the primary responsibilities of leaders in any industry is to develop and foster the cohesiveness of teamwork. Though simple in concept, it is probably the greatest challenge a leader faces. In order to meet this challenge, we must recognize the causes of team dysfunction and then develop strategies to address the problems. Moreover, leaders need to be able to effectively and impactfully communicate ..
Is your company ready for the next level of efficiency, productivity, and profit? Then you are ready to initiate and implement a Performance Management Plan.Your management can change the conditions of the workplace in order to measure the true success of your business. It includes activities that ensure organizational goals are consistently met in an effective and efficient manner. The overall goal of perf..
In today's diverse workplace is a reflection of North American society at large. Often we see a wide range of behaviours that display a lack of respect and politeness, both inside and outside the workplace. Various polls and studies have highlighted that workers view impoliteness as a serious issue which must be dealt with. As the workforce becomes even more diverse than it is now, it is important that each..
This webinar will help personnel in the Analytical Method Development Laboratory, Quality Control Laboratory and Quality Assurance understand the evolving expectations for analytical method validation. The paradigm that test method validation is one experiment performed just before method transfer must be replaced with a proactive, lifecycle approach that includes the three stages of Analytical Method Proce..
An employee hands in his resignation and walks out the door and with them walks out valuable skills, knowledge, and capabilities. You are sorry to see them leave and you don’t want to lose anymore. Also walking out is the key to how to keep good employees and how to make your business better than ever. The key is Exit Interviews.Exit Interviews can provide critical information that only leaving employees ca..
This webinar examines the scope and nature of employee dishonesty and explains the risks to employers and organizations of all types. It goes on to deal with the practical aspects of prevention and response to victimization, as well as balancing the need to assure that corrective and deterrent programs and policies do not unduly interfere with normal operations and opportunities and do not generate other ma..
1. This is a Business Relationship a. You are representing your Company or Agency b. You’re First Priority should be to look out for the best interests of your Employer c. Your Vendor will be looking out for their best interests d. Avoid getting into a personal relationship with your supplier or their representative2. Coming to Terms with your vendor a. Make..
Abuse under the Family and Medical Leave Act touches every employer. They are difficult cases because you must deal with it (or you lose your good employees because they are doing their co-workers’ work) but at the same time, you almost assuredly setting yourself up for a retaliation suit. How do you put your company in the best legal position while dealing with abuse? Since the Family and Medical Leave Act..
This webinar provides internal auditors with important information about how to approach their company’s audit of internal controls. It presents an overview of the current role of the modern professional internal auditor with an emphasis on its primary role of opening on the adequacy and effectiveness of internal controls. It shows the purpose and detail steps involved in an audit of the systems of int..
More and more people –often your employees suffer from mental illness. Whether this is a result of environment or better diagnostic tools is open to question. Those with a mental illness often deny this fact and often try to hide it from employers. Such is often a result of fear of being terminated or to avoid the stigma often attached to mental illness. As a result, mental health disorders often go un..
Non-tariff measures (barriers) are generally defined as policy measures other than ordinary customs tariffs that can potentially have an economic effect on international trade in goods, changing quantities traded, or prices or both (UNCTAD).Areas Covered Non-Tariff Barriers definition and objectiveDifference between a Direct and an Indirect NTBDirect NTB’s established by the Mexican ..
Pragmatic Approach to Pharmacovigilance/Drug Safety System Update Against the Latest New Requirements
In the last year/recent months, there have been a lot of changes in the pharmacovigilance requirements especially impacting the reporting to EudraVigilance, the Signal Detection Management (e.g. inclusion of EudraVigilance Data Analysis System as part of the Signal Detection Management, etc.) and the Risk Management activities. The course is aimed at providing some practical examples of the application of t..