1773 Kings Road, Vista, CA 92084-3640, USA
Tel 1-760-941-2040 or 1-800-698-2040, Fax 1-760-301-0308, e-mail: info@cce-us.com
About this course
All regulatory authorities expect healthcare manufacturers to comply with GMP regulations when they start manufacturing for clinical trials. The function of GMP regulation is to guarantee reproducible production of unadulterated, safe product of consistent quality.
Governments enforce compliance with GMP through comprehensive and exhaustive inspections of company sites. Non-compliance with GMP regulations is considered a serious offense and can lead to product recall, product seizure, facility closure and criminal prosecution of company management and employees.
This course is designed to provide employees of regulated companies and vendors and suppliers to health care manufacturers with the necessary knowledge of Current Good Manufacturing Practices to effectively function in this highly regulated industry and to comply with all GMP regulations.
YOU WILL BENEFIT FROM THIS COURSE…
if you are involved in the development or manufacture of a health care product.
if you belong to Quality Assurance or Quality Control
if you are responsible for GMP compliance or are auditing for GMP compliance
if you are involved in the manufacture of clinical test supplies
if you are involved in the project management of a new health care product
if you belong to facility engineering and maintenance
if your company is a supplier, vendor or contractor to the health care industry
if you simply need a better understanding of the current U.S. and international GMP requirements
THIS COURSE WILL IMPROVE YOUR KNOWLEDGE...
the U.S. and international GMP requirements
what regulatory authorities expect of you, your management, processes, equipment and facility
how to implement or augment the GMP structure in your company
how to stay within compliance
how to audit
how to prepare for being audited
how to behave during audits
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