Are you responsible for payroll or employer tax withholding compliance? Or maybe you were recently hired or promoted to the payroll department. During your indoctrination, you are surprised at all the interesting things to do and how important this role is to the success of the company. You begin to wonder just how much there is to learn. Join us for a quick briefing on the basic laws affecting payroll. Lea..
Complaint handling and Corrective and Preventative Action (CAPA) is considered by the FDA to be two of the most important areas to assure medical device safety and efficacy. They are in the top five areas where FDA finds problems during inspections and issues 483’s. Medical device developers must understand the complicated Complaint and CAPA process and have a strong CAPA program. A key understanding is str..
The US FDA expects that as part of a product development Design Control Program risk management will be conducted.FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard.One of the techniques described in ISO 14971 is Hazard Analysis. This is the most powerful of the risk management techniques because it considers risks in normal operation as well as fault conditions. FMEA and..
Your message may be a very important one but if no one is willing to listen, its value will be lost. Effective Communication is a commonly used phrase; wherein, effective basically means being successful in what you are trying to accomplish. While you have been successful in sharing the information, it is important that what has been shared is understood and meaningful. Less than 10% of what you say is part..
In today’s fast-changing world financial environment plays a crucial role in influencing the economic growth, investments, employment, external trade, inflation, interest rates, credit demand and supply, exchange rates, purchasing power, consumer spending, Government Budget, and also your wealth, investment, financial planning, and economic wellbeing. It is, therefore, imperative to understand how the polic..
Building great workplaces where employees contributions are acknowledged and encouraged requires a foundation of trust and authenticity. The problem with a one size fits all approach to employee recognition such as the typical annual awards’ event where employees are recognized for years of service or a public announcement of cost reduction idea winner in the company newsletter is that employees don’t belie..
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..
Succession planning isn't just naming the new CEO. In fact, it's not about putting a name behind a title at all. That's called replacement planning. And when it is only used during times of crisis - when a company has to name somebody to fill a vacant role quickly - that's not succession planning either. That's crisis management. The goal of succession planning is to continuously identify and develop high-p..
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..