FDA & GMPs - Automating The Management & Control Of Employee Training Records To Comply With FDA Regulations

Document Control Systems (DCS), provider of integrated quality management software solutions, is offering a complimentary pre-recorded presentation and white paper on how medical device and drug manufacturers can automate and proactively manage employee training records to be compliant with FDA regulations.

Although FDA requirements for training are handled slightly differently between the Center for Drug Evaluation & Research (CDER) and Center for Devices & Radiological Health (CDRH), the FDA requires both drug and device companies to document, track and ensure proper employee training. The recording and white paper identify the regulations and the basis of these requirements. It will also examine the challenges that lead to general system failures; and how implementing an automated "training control" system can eliminate these shortcomings to improve efficiency and ensure compliance.

RECORDING DETAILS:

http://mailiwant.com/links.jsp?linkid=15769&subid=1013519&campid=137783&type=0

Carl Accettura, Sr VP of FDA Solutions & Validation Services at DCS, will explain FDA's regulations for managing training requirements for medical device and drug manufacturers. He will explain how FDA addresses training records in the most recent draft guidance, Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations, which was released in Sept 2004.

Brian Curran, Sr VP Product Development & Strategic Marketing at DCS, will participate with Accettura and present a new approach for meeting and going beyond tracking training requirements.

WHITE PAPER DETAILS:

http://mailiwant.com/links.jsp?linkid=15770&subid=1013519&campid=137783&type=0

The white paper will discuss the necessity of "training control" in detail within the following topics:

-- FDA's regulatory requirements for employee training & training tracking
-- Challenges of controlling training & records
-- Paper approach to managing & tracking training
-- Hybrid approach (paper & electronic) to managing & tracking training
-- Electronic approach to managing & tracking training

ABOUT THE PRESENTERS:

Carl Accettura has more than 20 years of diversified global experience in the manufacturing of pharmaceuticals and medical devices. Over the course of his career, Accettura has gained expertise in leading the implementation of enterprise-wide documentation, manufacturing, supply chain and quality systems. He has in-depth knowledge of a broad spectrum of life sciences manufacturing operations. His experience ranges from new product planning and time-to-market initiatives, to strategic planning, quality control, and project and supply chain management.

Brian Curran has 15 years of experience leading the direction for enterprise and entrepreneurial software development companies. He began his career with IBM, spending 5 years leading consulting engagements with Fortune 500 companies, such as MCI, BellSouth and many others. After this, Mr. Curran held several director and VP level product management and marketing positions for entrepreneurial software development companies in the telecommunications and web analytics space.