Highlights of the seminars will include the latest initiatives taken by Margaret Hamburg, M.D., the new Commissioner of Food and Drugs. The seminars will review the six systems the FDA use within their abbreviated and full inspection audits and why they may choose one over the other. Validations will be reviewed to include elements within the process, API, product, sterile product and cleaning of the total process/product equipment following use.
• Latest initiatives taken by the Margaret Hamburg, M.D., FDA Commissioner
• Updates to the FDA 21 CFR Parts 210/211
• The Six Systems involved in FDA abbreviated and full audits
• Process Analytical Technology (PAT)
• The management of electronic data based on 21 CFR Part 11
• Reviewing how GMP compliance can make your organization more efficient
• Understanding current FDA expectations through review of current Warning Letters
• Using Warning Letter information to improve your facilities performance and conformance to cGMPs
• "Pitfalls" encountered with Warning Letter responses
Who Should Attend
Those who will benefit from this seminar include Quality Assurance, Quality Control, Manufacturing and Facilities professionals who are required to maintain standards of compliance consistent with the latest revisions of the cGMP as well as those that use contract manufacturing and contract testing facilities.
• Where the FDA is headed under its new commissioner
• Learning how GMP compliance can enhance the efficiency of your organization
• Determining if your organization is meeting all six Quality System requirements
• How to use a Warning Letter to improve the Quality within your facilities
• How a quick response to follow-up with training may not be the correct response to an FDA 483/Warning Letter
• An opportunity to learn how others are meeting cGMP needs during the "live" Question and Answer session
All courses begin at 8:00 a.m. and end at 5:00 p.m. unless otherwise noted in course information posted on the website or in the course brochures.
Please arrive at your course location approximately thirty minutes before the start of the course to register and receive your course materials. Please be sure to bring your confirmation letter as proof of registration during check-in. You will not be able to attend a course without payment, or guarantee of payment.
A continental breakfast will be served before class beginning 7:30 a.m. Lunch will be provided from 12:30 - 1:30 p.m. Snacks will be provided during the morning break from 10:00 - 10:30 a.m. and the afternoon break from 3:00 - 3:30 p.m.