National Courses Taught by Former FDA Investigators Examine Latest Strategies for Integrating Quality and Risk Management
A series of FDA compliance training courses taught by former FDA investigators will examine the regulations and best practices for integrating quality and risk management. Courses will be held in Charlotte, NC, and Providence, RI.
Hyattstown, MD, March 24, 2008 --(PR.com)-- The latest FDA compliance strategies – including the integration of quality and risk management systems – will be examined in a series of training courses presented by EduQuest, Inc., this year in Charlotte, NC, Providence, RI, and Scottsdale, AZ.
The classroom training consists of four complementary programs:
- FDA Auditing of Computerized Systems and Part 11 (3 days)
- Introduction to Systematic Risk Management (1/2-day)
- Process Risk Management (1 ½-days)
- Corrective and Preventive Action (CAPA) Systems (1 ½ -days)
The FDA Auditing course is based on materials and exercises EduQuest originally developed to train Agency officials to inspect computerized systems and interpret 21 CFR Part 11 during visits to FDA-regulated manufacturing facilities, pre-clinical laboratories, and clinical investigational sites.
The lead developer for the courses is Martin Browning, president of EduQuest, a former FDA investigator, and the former vice chair of FDA’s Electronic Record and Signature Work Group, where he helped to write the original Part 11.
Dates for the courses are April 28-May 2 in Charlotte and September 22-26 in Providence. Dates for the Scottsdale courses will be announced later this year.
Students may elect to attend the entire week of training classes or select individual programs. Tuition for the full week of training is $3,980, with discounts available for teams of two or more attending from the same company.
EduQuest has been providing consulting, auditing and training services to the global pharmaceutical, biologics, and medical device industries for more than 12 years. Course details are available by visiting www.eduquest.net or calling 301-874-6031.
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The classroom training consists of four complementary programs:
- FDA Auditing of Computerized Systems and Part 11 (3 days)
- Introduction to Systematic Risk Management (1/2-day)
- Process Risk Management (1 ½-days)
- Corrective and Preventive Action (CAPA) Systems (1 ½ -days)
The FDA Auditing course is based on materials and exercises EduQuest originally developed to train Agency officials to inspect computerized systems and interpret 21 CFR Part 11 during visits to FDA-regulated manufacturing facilities, pre-clinical laboratories, and clinical investigational sites.
The lead developer for the courses is Martin Browning, president of EduQuest, a former FDA investigator, and the former vice chair of FDA’s Electronic Record and Signature Work Group, where he helped to write the original Part 11.
Dates for the courses are April 28-May 2 in Charlotte and September 22-26 in Providence. Dates for the Scottsdale courses will be announced later this year.
Students may elect to attend the entire week of training classes or select individual programs. Tuition for the full week of training is $3,980, with discounts available for teams of two or more attending from the same company.
EduQuest has been providing consulting, auditing and training services to the global pharmaceutical, biologics, and medical device industries for more than 12 years. Course details are available by visiting www.eduquest.net or calling 301-874-6031.
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Contact
EduQuest Inc.
Martin L. Heavner
301-874-6031
www.eduquest.net
Co-Contact:
Cece Bland
301-874-6031
cecebland@eduquest.net
Martin L. Heavner
301-874-6031
www.eduquest.net
Co-Contact:
Cece Bland
301-874-6031
cecebland@eduquest.net
Contact
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