Course "Requirements for Establishing an Effective Cleaning Validation Program" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. GlobalCompliancePanel Refer a Friend Program: Any Customer to 3 Referrals "Can Participate 2 Days Seminar for free of Cost Overview: This 2 day course will cover practical guidance on cleaning validation regulatory compliance, in conjunct...

Course "Clinical Research for Cardiovascular Pharmaceuticals: Ensuring Compliance of Traditional and New Cardiovascular Medications" has been pre-approved by RAPS as eligible for up to12 credits towards a participant's RAC recertification upon full completion. Overview: Understanding basic clinical research requires excellent people and project management skills, and very good scientific writing and organization skills. Also paramount is gathe...

Overview: A management system, by definition, is a process by which a function or functions are carried out in an organization by a series of hierarchal documents that are prescriptive, and set a particular path on which the organization manages its day-to-day operations. A management system can be for one function, but more often than not, it incorporates many functions. Functions like accounting, engineering, banking, etc. have their own man...

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...

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,...