Course "Regulatory Affairs aspects of clinical trials and clinical Product Development in the EU" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: The main document from a regulatory perspective in the development of a medicinal product is the regulatory plan. In this Seminar it is explained how to write the regulatory plan, and which aspects to consider....

Course "Applying U.S. FDA Laws and Regulations to Each Phase of Total Product Life Cycle (TPLC)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This workshop style training course is supported by comprehensive knowledge of U.S. FDA laws and regulations and 30 year of extensive experience working within in the U.S. FDA regulated industries. In these 2 da...

Overview: This two day seminar will provide the foundation for the application, concepts and theories of clinical research. Within the two days, attendees will learn about the historical evolution of research, current regulations and guidelines including the Common Rule, FDA regulations and HIPAA. We will discuss site and study staff responsibilities in the conduct and reporting of research, types of studies and the regulatory requirements tha...

Overview: In keeping with the book published by McGraw Hill, what key steps do you want to take TODAY to address your effectiveness with: Managing a team Customer service Communication Facilitating change Removing troublemakers Managing your boss Clashes between two teams Managing performance Budgeting Taking a team from any of three stages to peak performance Managing a remote team or teams effectively Why should you attend? Would you like yo...

Overview: If you are looking for ways to improve your Corporate Expense Account Oversight and Reporting, you will find best-of-breed practices and suggestions at a basic level. Finance and Operational staff will find this presentation interesting and informative. This webinar will provide you with some of the best practices in corporate expense account review used today. Why should you Attend: In today’s busy corporate environment staff...

Overview: There are many forms of ethical behavior, and it is good to know what they are when performing the required tasks of the EHS function. This session discusses those forms, plus outlines situations in which ethics play an important part of decision making, both from a professional and a personal perspective. The session also covers situations that the participants have experienced (without giving away names of people or organizations),...

Join the ACT-IAC Small Business Alliance on Wednesday, February 10th at 1307 New York Ave. NW in Washington, DC for Straight Talk featuring Gladys Bailey, Acting Director of the Office of Small and Disadvantaged Business Utilization (OSDBU) for the Department of Labor. The mission of the OSDBU for the Department of Labor is to administer their small business program in accordance with the Small Business Act. Their priority is to ensure that sm...

Overview: Manufacturing involves an attempt to produce items that as closely as possible meet design specifications (e.g., size, strength, etc.). However, all production processes exhibit variation - that is, no two items are identical. What method can be used to reduce such variation? The classic and still most widely used method is called SPC or "statistical process control". SPC is a statistical tool that objectively identifies when it is w...

Overview: This webinar will provide guidance on how to validate cleaning in terms of allergen removal and it is intended for use in all operations. Very small amount of some allergens such as nuts can cause adverse reactions, including potentially fatal anaphylactic shock. Therefore where HACCP/allergen management plans identify cleaning as a prerequisite to ensure adequate removal of allergens, it is important that cleaning procedures can be...

Overview: In financial institution, operational risk has been considered as minor compared to credit risk and market risk. Moreover, Operational Risk is too difficult to grasp for bankers. Therefore operational risk management is often considered as a regulatory constraint or as an imprecise practice rather than a science, and it is often hijacked by political necessities, or can turn into insignificant exercises aimed at predicting small loss...