This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by an explanation on how to get from..
In the workplace, you might think that being accountable means you're the one who gets blamed when things go wrong. In fact, accountability is about helping people to take responsibility for their obligations.It's up to you to make sure your team knows what they are supposed to do and that they have what they need to get the job done. This webinar gives you the tools to hold your employees accountable and c..
ADA Accommodation and Compliance: What should the Process between Employer and Employee should look like?
This webinar explores the issue of what should the process be between employer and employee when trying to accommodate individuals with disabilities while complying with the Americans with Disabilities Act. All companies, employees, and applicants for employment that want to learn about who is covered under The Americans with Disabilities Act (ADA), as amended (ADAAA) by should attend this webinar to o..
Allergens are now a Class I Recall by the FDA (Food & Drug Administration), considered an adulterant in foods. It is the largest area for recalls in the US and growing at a staggering rate. Anyone wanting to know how to approach, improve or review their Allergen Management Program should participant to understand the latest information for Best Practice preventative controls. Important elements will inc..
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..
So, you’ve just been promoted. There are few career moments as exciting and these days as perilous as becoming new a team leader or manager of a department or business unit.Moving into a managerial role requires the development of leadership skills and techniques to enhance your personal and team outcomes. Leading others requires a greater level of self-awareness and core skills such as strategic thinking, ..
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..
The FDA has published guidance regarding the types of meetings that will generally be granted and the information needed to conduct the meeting. However, the guidance tends to be general and interpreted in multiple ways. This topic will provide practical examples and suggestions for standard meetings as well as requesting and conducting non-typical meetings (such as during fast track, the clinical hold, or ..
HIPAA and the Administrative Subpoena – How HIPAA Does or Doesn't Protect you When the Government comes Calling for your Patient Records and you are in Trouble
This webinar reviews core privacy requirements of HIPAA then covers in detail the ways state licensure boards and agencies use the authority of state law to cover HIPAA exceptions and gain access to your patient records. This webinar shows how state agencies use state law in concert with HIPAA exceptions to conduct government-lead investigations. These exceptions can also be used by federal agencies in the ..
Attendees will learn about the different elements that make up a standard procurement procedure. The topic will cover those looking to improve or change a current procurement policy or program and also for those starting from scratch. Attendees will learn about technical areas to include in structuring a new or improved procedure or program and then will follow along on a real case study involving creating ..
Each year, Federal tax refund time presents a nightmare of situations for institutions. From money mules to identity theft, nasty divorce situations to non-post items, institutions sometimes find themselves in high-risk situations with no clear guidance on how to proceed. Institutions need to be prepared for the onslaught of situations the tax refund season presents. Regardless of the scenario, there are so..
PivotTables are the most powerful data analysis feature in Excel, combining the ability to sort, filter, subtotal, calculate and chart data in minutes.A Pivot Table display a summary of a selected data set in a condensed format of rows, columns, data fields, and pages. These components can be “pivoted” with your mouse allowing you to expand, isolate, calculate, and group the particular data in real time. Th..
Sales and Use Tax is among the most complicated areas of compliance there is. 45 states levy a state-wide sales tax and each state does it differently. In addition, the digital era and online purchases bring with it its own issues. This webinar will teach you the basics of the sales and uses tax environment and how best to comply. We will touch on audits, and when use tax might apply to a given situation. F..
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..
This webinar will help Sponsors, CROs in the US, EU and internationally; understand how to write SOPs to comply with inspection requirements.The lack of or inadequate standard operating procedures (SOPs) continue to dominate the FDA's and other regulatory inspector’s inspection observations. This is often caused by poor writing and management and control of SOPs. SOPs need to be easily understood by all tho..