Course "Texting and E-mail with Patients: Patient Requests and Complying with HIPAA" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: With the recent advances in portable technology, more and more organizations and their users are taking advantage of mobile devices to save time and get work done more efficiently. Texting, portable e-mail, and Apps are rev...

Overview: Educational material discussed during this seminar will include both effective sanitation and hygienic practices and the control of microorganisms that cause spoilage and foodborne illness. After a discussion of microorganisms found in meat products, safety issues will be addressed and contamination sources identified. Practices to reduce contamination such as personal hygiene and Good Manufacturing Practices (GMPs) will be discussed...

Course "HIPAA Privacy Security - Time to Get Serious" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Brian has conducted over 400 risk assessments for business associates and covered entities alike as well as worked directly with the Federal government in terms of auditing. This seminar will go into great detail about what is going on in the HIPAA Secur...

Course: "The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting 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 tra...

Course "The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting 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 trai...

Course: "The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting 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...

Overview: This course will review the company Master Validation Plan for major key inputs and CGMP deficiencies. It will address the FDA's newer & tougher regulatory stance. This course's aim is to prove "Product Risk Based V&V" by sufficient, targeted and documented risk-based V&V test case elements/scripts. It will teach participants to evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk manage...

Course: "The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting 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 tra...

Overview: The FDA recalls related to software performance are on the increase for at least five years at the time of this writing. Software failures were behind 24 percent of all the medical device recalls in 2011, according to data from the FDA. Similar to hardware, software also has hazards (any source of harm) and hazardous situations which transform a hazard into harm. We must identify hazards and identify what event can turn them into har...

Overview: Drug development is the process of incorporating data from multiple disciplines into a logical and coherent argument for the efficacy and safety of a drug product resulting in regulatory approval. The course will focus on the clinical aspect. The primary goal of the course will provide students with the basic principles and process for taking a chemical and developing it into a drug product. Medical, pharmaceutical, pharmacokinetics,...