Compliance Key - Compliance Online Training Webinars, Regulatory, Medical Device, FDA, Financia

Compliance Key INC  - Life Science Webinars   Overview Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product. The design, construction and monitoring of a compressed air system is essential for maintaining a quality system without contamination of the product. Proper testing of compressed air quality according to international standards is important for both validation and ongoing monitoring of the system. Why should you attend this webinar? Compressed air is often overlooked as a potential source of clean room and product contamination. This webinar will give you an understanding of the different types of contamination inherent in compressed air and how to prevent each from affecting your particular system. A detailed description of a typical pharmaceutical compressed air system with its individual components is provided. Engineering schematics are ...

Compliance Key INC  -  Medical Device Training Overview Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the product from contamination. Therefore, the design, validation and ongoing monitoring of a clean room HVAC system is necessary to assure the quality and safety of the pharmaceutical product. Also, a proper understanding and testing of the clean room environment according to international regulatory standards is important from a compliance perspective. Why should you attend this webinar? It is important that a clean room's HVAC system is fully understood, properly designed and properly validated. If this is accomplished, it will provide the environmental control necessary to meet the regulatory particulate and mic...

Compliance Key INC  -  Compliance Online Training                                             Roger Cowan Roger Cowan is the Keynote Spaker at Compliance Key Inc. He is the founder and owner of R Cowan Consulting Services LLC, a consulting company specializing primarily in the area of pharmaceutical contract manufacturing. He has 35 years experience in pharmaceutical quality assurance and manufacturing.  Webinar Id:  LSHCRC007  10:00 AM PT | 01:00 PM ET  12/07/2017  Duration 60 mins Overview A Quality Agreement is a contract between a pharmaceutical firm and a GMP Contract Manufacturer detailing the responsibilities of each party in assuring the quality, safety, and efficacy of the manufactured drug.  Recently, the EU and the FDA issued regulatory guidance to bring some clarity and consistenc...

Angela Bazigos, is the CEO of Touchstone Technologies, Inc. She has 40 years of experience working in hospitals and Pharma industry. Her background includes companies like Roche, Novartis, Genentech and PriceWaterhouseCoopers in GLP, GCP, GMP, Medical Device and Data Integrity Roles. She has held positions such as Chief Compliance Officer, QA Director and has acted on behalf CEO for communications with FDA.  Webinar Id:  HIPAB001 Time: 10:00 AM PST | 01:00 PM EST Date: 09/29/2017 Duration 180 mins  Overview HIPAA, which stands for Health Insurance Portability & Accountability Act, does not just apply to health insurance. The rules apply to all companies with Personal Health Information (PHI) in electronic formats -doctors, health plans, pharma organizations, government programs, research organizations, testing organizations, pharmacies, clinics, IT services for regulated organizations, and more. In March of 2013, the HIPAA Omn...