Medical Device Risk Management Following ISO 14971:2019
The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects that a post-production risk management program is implemented. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard. Hazard Analysis is described in ISO 14971. This is the most powerful of the risk management techniques because it considers ris..
Outlook for Attorneys: Law Office Rules for Productivity
A partner is valuable in any endeavor but especially in such a complex issue as productivity. You need a partner to keep you on track when interrupted, when distracted by miscellaneous thoughts that pop in your head, and when you have concentrated, taken a break and need to get back on track. This is a “must-attend” and “don’t miss” webinar for attorneys who want to sharpen their work habits, prioritize for..
The Development and Implementation of a Hands on Day to Day Environmental, Health and Safety (EHS) Operating Manual
Most environmental, Health and Safety (EHS) guidance is provided from program management. This includes guidance on matters such as compliance, audit and management systems, for example, ISO 14,001. There is little guidance provided for day-to-day EHS activities. Learning is usually by trial and error. There is general uncertainty if things are being done correctly or perhaps not. If you are trying to antic..
How to Create Team Spirit When Mainly Working Virtually
There are many virtual communication tools. What’s the difference between using phone or using one of the many video conferencing tools? What features should you learn to use so you can increase team spirit, motivation? How can you get the team members to eagerly await the sessions rather than dread them?In this program, we will address the benefits and detriments of virtual team interactions and many engag..
Implementing Purchasing Policies
This live webinar is intended to provide attendees with information on implementing purchasing policies for purchasing professionals. Attendees should leave the program with practical applications that they can apply to their daily business. Topics may include: outlining the strategic role of purchasing in the organization, latest business writing techniques suited for the development of policies,..
Technical Managers: Hired for Hard Skills & Fired for Soft Skills
The basics of great management are the same whether in the technical or non-technical sphere because you are dealing with human beings. The key is to develop a plan to implement any and all assignments and then delegate the detailed tasks to technical professionals to execute using proven methodologies and keeping individuals motivated. Coaching each person to get the results you are responsible for and hel..
Understanding Initial IND Submission - The First 30 Days
This webinar will shed light on the entire process that takes place from the time the sponsor submits the initial IND to the FDA for an initial 30-days. Alongside this presentation would detail the various grounds on which the FDA may consider placing a clinical hold. What’s more; the options/ ways to respond to the clinical hold are also discussed to help the sponsor effectively work toward the resolution ..
7 Attributes of High Octane Leaders
This webinar is designed to assist the participants in the rapid assimilation of new ideas that can become part of their managerial and leadership repertoire. The notion of “Personal Kaizen” will be introduced in terms of developing, embracing, and incorporating new ideas that will bring about changes in behavior. New Idea assimilation will be introduced in terms of a concept called “The Slight Edge”.Person..
Good and Bad Practices in Risk Analysis
Selecting the most appropriate risk treatment option involves balancing the costs and efforts of implementation against the benefits derived, with regard to legal, regulatory, and other requirements such as social responsibility and the protection of the natural environment. A number of treatment options can be considered and applied either individually or in combination. Risk treatment itself can introduce..
Answering and Replying to an FDA 483
A brief introduction into the FDA 483 and its use. Responding and responding appropriately is extremely important. This is not an advanced course on 483 response but a recommended approach to best position your company to prevent even worse FDA regulatory measures. All pharmaceutical and medical device facilities who need to know how to react to FDA 483s. Properly responding to FDA observations will make or..
Technical Writing: Best Practices for Everyday Use
Most companies have in-house requirements that all documents produced within the organizations conform to the firms’ particular requirements. The purpose of this webinar is to define and clarify general guidelines for the creation and maintenance of documents in order to ensure consistency between documents created by various functional groups within organizations. This webinar will describe the best practi..
Handling a Chaotic Work Environment: How to Prioritize Work and Make Good Decisions Under Pressure
This highly interactive Webinar offers you and your team an array of practical tools to help you get things done in today's chaotic and constantly changing work environment. You’ll learn practical techniques for making structured decisions—even under pressure—to earn buy-in from bosses, coworkers, and customers. In a workshop environment, you will participate in valuable exercises utilizing real-world case ..
Fact-Based/Evidence-Based Decision-Making
The evidence-based decision-making process is a step-by-step (Systematic) process allowing professionals to solve problems by weighing evidence (facts), examining alternatives, and arrive at the correct (effective) decision. Fact-based decision-making Webinar will cover the basics of scientific problem-solving, knowing what decision(s) should be made. In anything we do, the main objective is “effectiveness”..
Fundamentals of Toxicology for the Pharmaceutical Industry
In toxicology, it should be possible to distinguish expected pharmacology (related to the mechanism of action of the drug) from unexpected or abnormal pharmacology. Toxicity should also allow to rank molecules based on their intrinsic toxic potential and to identify potential adverse effects. These effects should be correlated in toxicology with the exposure, to assess the presence of a dose-response. Overa..
Leading When You’re Not In Charge! Leadership Without Authority
Whatever it is we call ourselves in the office, we all need to get work done while dealing with other people. But leadership today isn’t like 40 years ago. Getting people to work by saying “because I’m the boss” just doesn’t work anymore. Because being a leader isn’t about having authority or exercising power. Being a leader is a learned skill. It means acting in a way that people are moved to action by you..