WASHINGTON, Jan. 15, 2014 /PRNewswire/ — EduQuest – which has trained hundreds of FDA inspectors in the past 19 years – is now training FDA-regulated companies to prepare for inspections of their quality systems and automated processes.
(Photo: http://photos.prnewswire.com/prnh/20140115/PH46646)
A global team of FDA compliance experts based near FDA headquarters in Washington, DC, EduQuest will present FDA Auditing of Computerized Systems and Part 11/Annex 11, April 7-9, 2014, at the Hilton Garden Inn in Frederick, Maryland. The three-day training course includes three hands-on, mock FDA inspections teaching Agency expectations for:
- Highly configurable systems used for complaint management, adverse event reporting, and other quality management functions;
- Vendor-hosted learning management systems (LMS), including cloud-based services;
- Hybrid custom/off-the-shelf manufacturing execution systems (MES) with complex network configurations and change control and data monitoring challenges.
In addition to providing simulated FDA audits, the class explains the FDA Part 11 regulation and the EU Annex 11 guidance for managing electronic records and ensuring data quality; clarifies FDA expectations for software development and validation, and provides lessons learned from FDA regulatory enforcement actions.
The class is designed for quality managers and those responsible for regulatory compliance, clinical data assurance, internal audits, document management, and IT engineering at pharmaceutical, medical device, biotechnology, clinical research, tobacco, and food companies.
Since its founding in 1995, EduQuest has trained staff in the FDA Office of Regulatory Affairs (ORA), which is responsible for FDA field inspections and product recalls. In addition, EduQuest has trained and advised industry professionals worldwide. Martin Browning, the president of EduQuest and primary developer of EduQuest training classes, co-wrote the FDA Part 11 rule for electronic records and electronic signatures during his 22 years at FDA.
Tuition for the FDA Auditing of Computerized Systems and Part 11/Annex 11 training class is $2,795. Immediately following the class, EduQuest also will offer two-day classes on CAPA Systems and Quality Risk Management.
FDA inspection and quality system course details are available on the EduQuest website or by calling +1 (301) 874-6031. By email, contact Email at Email.
Further Information: Martin L. Heavner
Email
301-874-6031