Course "Risk Analysis and Design of Experiments (DOE) in Process Validation and Development" 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 help scientists and engineers plan and conduct experiments and analyze the data to develop predictive models used to optimize processes and products and solve complex problems. DOE is an e...

Overview: Design Controls are essential for producing safe and effective medical devices. And Design Controls are considered a critical process by the FDA. Yet is still one of the most frequent areas for 483 and Warning Letter observations. This 2 days seminar will help you understand and develop design controls processes and tools that are a competitive strength for your company. Intrinsic quality, safety, and effectiveness of a device are kn...

Overview: Have you had the experience of guiding a new product through concept, development, and final design, and, while you are preparing the product for US introduction, you suddenly stop dead. It seems FDA has decided your product is a medical device! The basic definition of a medical device is extremely broad, including "instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article,...

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, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems. The instructor will provide the necessary background needed to understand this very import...

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, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems. The instructor will provide the necessary background needed to understand this very import...

Course "Mastering Biofilm Control, Monitoring, Validation and Excursion Investigations of Water Systems for Bio/Pharma, Medical Devices, and Cosmetics Industries" 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. P...

Increased Revenue & Profit For Your Practice! Better Service & Outcomes For Your Patients From Your Existing Patient Base! This seminar will provide you with the following critical information and materials: How to develop Profits $5,000-$20,000+ Per Month, Per Doctor though Durable Medical Equipment (with but a few patients a week or day) How to Become Immediate Positive Cash-Flow How to provide a "Convenient One-Stop Medical Shopping...

Overview: I will be going into great detail regarding you practice or business and how it relates to the HIPAA Security/Privacy Rule. Areas covered will be history of HIPAA, privacy vs security, business associates, changes for 2016, audit process, paper based PHI, HIPAA and suing, texting, email, encryption, medical messaging, voice data and much, much, more. I will uncover myths versus reality as it relates to this very enigmatic law based...

Course "Applied Statistics, with Emphasis on Risk Management in R&D, QA/QC, and Manufacturing" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: The 2-day seminar explains how to apply statistics to manage risk in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics ov...

Course "Bullet Proof 510(k) and Latest FDA Proposed Changes to the Process" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This Two-day course is a primer and overview to the premarket notification process, i.e., a 510(k). A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, tha...