Compliance Global offers Regulatory Compliance Online trainings and webinars for Pharmaceutical, Bio-Technology, Medical Devices, Clinical, FDA, Healthcare, BFSI & Human Resource streams
Best Validation Practices for Laboratory Computer Systems Regulated by FDA. Overview We will discuss the importance of applying industry best practices when validating laboratory systems that are regulated by FDA.
Any “GxP” system (i.e., the system "touches" product during the laboratory testing or process) must be validated in accordance with FDA guidelines for computerized systems and documented accordingly. This FDA Compliance course will describe the best practices for conducting validation work, including "who" should be responsible for such tasks and "how" the documentation should be accomplished.
FDA guidelines are very specific in terms of how this is to be done. AML/BSA Requirements for Privately Owned ATMs. Speaker Profile Gina Lowdermilk is a highly experienced and educated BSA/AML and Financial Regulatory Compliance professional with extensive policy and procedure development and implementation, training, internal audit, monitoring, risk management, and reporting experience.
Her emphasis has been working with financial institutions that are experiencing regulatory concerns and resolutions, including enforcement actions such as memorandums of understanding and cease and desist orders. Her 15 years of experience has given her the opportunity to work from small community banks to large, international financial institutions. Managers as Coaches: Yes, You Can Boost Employee Motivation, Engagement and High Performance. Overview Managers who coach their people become known as good managers to work for, developers of talent, and achievers of business results.
They also become better leaders in the process.” -Jack Welch, Former CEO General Electric Are your people working harder yet performance is still below par? When a leader spends too little time managing performance, here’s what happens. Good managers regularly keep each member of their group or team informed about his or her work performance. Complying with the Federal Debt Collection Practices Act. Background Checks: What Employers Need to Know: EEOC employment discrimination. Speaker Profile Tom Palladino has held numerous HR leadership positions in companies that included Conoco Phillips, Starbucks Coffee, Wells Fargo, Capital One, First Data and Green Plains Renewable Energy.
His interest in HR Analytics started in 1998 while he was consulting for Starbucks. At that time Starbucks was growing rapidly around the world. Tom was tasked with designing a methodology that would identify employee attributes that correlate with business performance. His HR analytics model was initially applied to new subsidiaries in Asia and Europe enabling the company to inculcate select Starbucks values to create a “performance-driven brew”. In his HR leadership positions, Tom consistently applied analytics to identify high-leverage HR practices that delivered the highest possible business results.
Mitigating Top Fraud Risks for Businesses. FDA Regulation, 3D Printing and Medical Devices. Due Diligence Steps for Form 1099. Hazard Analysis following ISO 14971. Overview 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 FTA consider only fault conditions and are more suited as reliability tools than as product safety tools. In this ISO 14971 risk management training we will explain in detail the process of conducting a hazard analysis. We will explain how to integrate Human Factors studies into the Hazard Analysis and how to integrate Hazard Analysis into the design program. Why Should You Attend FDA expects that as part of a product development program risk management will be conducted.
Areas Covered in this Webinar Learning Objectives Learn to conduct a meaningful hazard analysis. Document Retention, you don't have to be overwhelmed with that all too frustrating Paper Chase. Overview The only constant today is change…and with regards to document retention policy and privacy, laws, regulations are changing all of the time.
You need to be diligent to know how, and if, your current policy is affected by these changes. Retention and management of records is more complicated than just deciding what to keep and for how long. In what form should records be kept? Should we keep more than what the regulations require? Starting Your Workplace Violence Program on a Shoestring Budget. Overview You already know if the violence erupts in your workplace the consequences can be unpredictable, and can be severe.
These include, but are not limited to, injuries or death of employees, customers, and/or visitors from workplace violence, in lawsuits, property damage, increased insurance premiums, OSHA enforcement actions, increases employee turnover and reduced community trust. Structuring and Auditing Physician Employment Agreements: Key Legal Considerations. Overview In recent years, the health care industry has seen unprecedented levels of physician employment.
Structuring employment arrangements appropriately and periodically auditing implementation are critical in today’s challenging enforcement climate. Why Should You Attend As health care organizations and physicians develop employment arrangements, they must manage their compliance and enterprise risk by ensuring the employment is defensible under the Stark Law. Corporate Expense Accounts Review and Audit Best Practices. Elements of a Corrective and Preventive Action (CAPA) Program and Uses of CAPA Data. Logistics Channel Incoterms Standards. Conducting Investigative Interviews Who, Why, What, When, Where, and How. How to Build and Use 360 Degree Feedback? Speaker Profile Chris DeVany is the founder and president of Pinnacle Performance Improvement Worldwide, a firm which focuses on management and organization development.
Pinnacle's clients include such organizations as Microsoft, Visa International, the Society for Human Resource Management (SHRM), U.S.