Course "US Medical Device Regulation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Break Overnight Clinical Trials IDE Other Export for trials Common problems in trial design and management Post marketing QSR CAPA Reporting Inspections Export for foreign markets Pop quiz Give quiz Discuss questions and answers Why should you attend? Have you had the e...

Course "Tougher Import Rules for FDA Imports in 2016" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: FDA's and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of information and adherence to government procedures. Firm's that fail to understand and properly execute an import and...

Join us December 16 as a panel of journalists-turned-public affairs officers reveals what they’ve learned in the often challenging and eye-opening transition from media to government. Our guests will include: John Poirier, formerly of Reuters and now with the U.S. Office of Financial Research Rich McIntyre, former managing editor of The Calvert Independent and since with various state and federal agencies Rob Margetta, one-time editor of...

Overview: The webinar covers factors considered by FDA before, during and after an inspection that can be used to predict your inspectional vulnerability. Once you know some key points, you will see that FDA's approach to inspections follows well-established procedures and risk criteria that enables FDA to characterize your firm's compliance. Usually the only way FDA will let you know about your profile is when an official action is indicated....

Overview: Business Administration is often very generalized and even more often overlooked by project managers. This course is targeted to teach you the strategic and business administration concepts that are specific to project management. Too many times we try to manage our projects in a vacuum without awareness of how we impact the company overall, and how the company overall impacts our performance as project managers. Why should you Atten...

Overview: Biosimilars in the US, including new regulations, existing guidelines, direction from Congress, meetings with the FDA, INDs that have been filed and NDAs that have been filed. We will also discuss the current state of affairs in Canada, who seems to be closely aligning itself with Europe. Finally, we will address Europe and where the landscape is in terms of approval and market accessibility. We will address an interchangeability stu...

Day One * 7:30-8:00 Continental Breakfast (Provided) 8:00-8:30 Introduction Curtis Wehr/Tiffany Jones 8:30 - Noon QuickBooks Seminar Chart of Account Design (Direct, Indirect, and Unallowable Segregation) Data Entry (Segregation of direct and indirect costs) Set-up Customer Job Center Set-up Employee Center Timecard Compliance and Entry Labor Allocation Payroll Reconciliations Job Cost Report Design and Set-up Contract Segregation—Contr...

Overview: FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are maj...

Course "Surviving an FDA Inspection: Understand the Do's and Don'ts and the Ground Rules" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on ho...

Course "Mastering Biofilm Control, Monitoring, Validation and Excursion Investigations of Pharmaceutical Water Systems" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training,...