Sterile Filtration of Pharmaceutical Products - What you need to know to meet Validation and Regulatory Requirements
It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the filtration requirement. This webinar will give you a comprehensive understanding of this important subject with an emphasis on the different types of sterilizing filtration available and their application to your par..
The Disruptive Practitioner: A Danger to the Hospital's Operation
Most disciplinary policies are progressive. A progressive policy applies increasingly more severe sanctions to additional incidents of bad behavior. It is very important that the organized medical staff have a disruptive practitioner policy. This webinar will discuss the development of such a policy, including what it should include, and how it should be implemented.It is also important to understand what c..
Update - FDA Humanitarian Use Device (HUD) / Humanitarian Device Exemption (HDE) Programs
The passage of the 21st Century Cures Act and the recent release of draft guidance from FDA signal changes ahead for the Humanitarian Use Device and Humanitarian Device Exemption Programs in the US.Whether you work strictly with medical devices, or with device combination products you will not want to miss the opportunities afforded by these changes. The requirements for qualifying for Humanitarian Use Devi..
What Policies Should be Part of Your Employee Handbook in 2019 or Risk Lawsuits in 2020!
Employee handbooks have been a tool for Employers from small to large companies for several years. Many companies elect to have employee handbooks and utilize employee handbook templates that are provided online which we call “cookie cutter handbook” since they are created as a “one size fits all”. Unfortunately, employee handbooks can be a huge risk if not updated regularly, adapted to each company, reflec..
Best Practices for Working with Vendors and Suppliers
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..
FDA Adverse Event Reporting
This training program will provide the regulatory requirements for complaint handling in the pharmaceutical & medical device industries. The course will touch on complaint sources and details will be furnished on the interrelationships regarding complaint handling and product recalls. The course will also include timeline requirements associated with adverse event reporting. Areas Cover..
Handling FMLA Abuse
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..
Project Management For Non-Project Managers
Today, much work in organizations is organized as a project although it may not be called a project. Often, through years of downsizing, people with in-depth special knowledge in critical areas are no longer available. The work still needs to be performed when needed, so someone is assigned. Thinking about these special, periodic assignments as projects and applying the approaches of project management help..
CAPA System
FDA, EMEA, and ISO9001 want you to have a CAPA system in place. This is the first of three in themselves closed Session about CAPA system (the basics)Change is unavoidable; it attacks your processes and products at all times. The creation of a CAPA system should not be an empty exercise in regulatory compliance but an integral part of the company’s risk mitigation; against all forms of negative influences o..
Comprehensive Review of Budgeting Best Practices
This webinar will provide an overview of the best tools to transform the planning cycle into an evolutionary process, bringing tangible and intangible returns for the organization. This is the most comprehensive condensed costing best practices course available!Whether a public company, private enterprise, or a not-for-profit organization, budgeting is vitally important to any entity.Learning ObjectivesSimp..
SOPs for Commercialization
SOPs are standardized procedures and processes prepared with enough detail to ensure that tasks are performed consistently each time they are done. SOPs are also required to be in compliance with regulations and guidelines internationally, across all regulated functions, including sales, marketing, manufacturing, quality, and regulatory affairs. An absence of and non-adherence to SOPs are often cited in reg..
ISO 14001 Environmental Management Systems
ISO 14001 is an internationally agreed standard that sets the requirements for environmental management systems. It helps organizations improve their environmental performance through more efficient use of resources and reduction of waste, gaining a competitive advantage and the trust of stakeholders. ISO 14001 is suitable for any organization -- all types and sizes, be they private, not-for-profit or gover..
Multi-State Nexus: What you need to know after the Game Changing Wayfair Decision
As businesses use more and more e-commerce to reach customers, it becomes highly likely that the business will eventually cross state lines. Most companies are comfortable collecting and remitting sales tax to their home state but often struggle to know when and why state sales taxes may need to be collected from different states. For the longest time, these companies were able to rely on a Supreme Court ca..
Psychiatric Illnesses in the Workplace
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..
Six Sigma Principals for Process Improvement in Clinical Research
Managing clinical trials, of any size and complexity, requires strategic planning and efficient execution. In order to successfully deliver innovative therapies to patients with unmet medical needs the trial management guidelines need to be standardized further, and robust methods of evaluation of study protocol complexity developed in conjunction with risk management strategies and process improvement impl..