Overview: Investigational device accountability is outlined in the FDA's regulations. Included in this topic is the receipt, storage, distribution, reconciliation, return and authorized destruction of investigational devices. Many industry sponsors already have standard operating procedures outline these policies but there are instances when a standard operating procedure or guideline does not already exist and those working with these devices...

Overview: Mental health care practitioners work in today's diverse, fast-changing, multidisciplinary health care environment. Nowhere but in mental health is there such diversity of clinicians who provide the same or similar services of counseling and therapy. A potential client has a wide choice of mental health providers from whom to choose. Yet each individual mental health profession has a unique education, training, and experience require...

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 over the 2 days is as follows: ISO standards and FDA/MDD regulations regarding the use of statistics. Basic vocabulary and concepts. Statistical Process Control Statistical methods for Design Verification Statistical methods for P...

Overview: Regular review and monitoring of product information for medicines is important, to support awareness of relevant updates/changes which may affect prescribing, dispensing, administration or monitoring practices. It is also important that patients and caregivers, as appropriate, are made aware of the information contained in the Package Leaflet (PL) and should be encouraged to read it prior to and during their treatment. The PL reflec...

Overview: This course will present the regulations and guidelines that apply to operations in quality control testing laboratories. In some cases these will not be specific regulations, but needs that, if met, will increase the efficiency or quality of activities in the laboratory. While it will not be possible to cover all of the subtle variations among regulatory regions, general internationally accepted practices that comply with GMP requir...

Overview: This course will present the regulations and guidelines that apply to operations in quality control testing laboratories. In some cases these will not be specific regulations, but needs that, if met, will increase the efficiency or quality of activities in the laboratory. While it will not be possible to cover all of the subtle variations among regulatory regions, general internationally accepted practices that comply with GMP requir...

Overview: In 2013, The US Department of Health and Human Services made major changes to rules implementing The Health Insurance and Portability Act of 1996 (HIPAA) and Health Information Technology for Economic and Clinical Health Act of 2003 (HITECH). Among the many areas impacted by these rules (billing, marketing, research, IT security, etc.) is fund raising. The amendments significantly modify the methods and practice that hospitals, their...

If your company is a SDVOSB or VOSB, Use code Vet and take $99.00 Off the Price of This Event GovConectx Presents: Winter Showcase Small Business Expo, MatchMaker and Seminar January 21, 2016, 9:00 AM to 3:00 PM 6633 Arlington Blvd, Falls Church, VA 22042 at the Best Western, Falls Church VA 22042 Keynote Speaker: VADM Lou Crenshaw USN (Ret.) This Event is designed to give you Maximum Exposure: Expo, MatchMakers and Speakers MatchMaking: 10 m...

Overview: Medical identity theft is a growing threat in the nefarious world of identity theft. Although it is not as well-known as financial identity theft, the impact of medical identity theft is long-lasting and life-threatening. It affects one in four Americans and accounts for three percent of all identity theft cases, or approximately 500,000 cases per year. With only one arrest made in every 700 cases, medical identity theft costs consum...

15th year! Government Marketing Best Practices 2016 is a half-day session covering what works in business-to-government marketing, from traditional methods through web 2.0 tools. This is one of the longest running seminars in the government market, started in 2002 and visiting over 20 cities throughout the U.S. This workshop is updated 2/x a year to stay current with the changes occurring in the GovCon community. You must register in advance t...