From birth control to thyroid medication, millions of women take medication each day for a variety of ailments. While most women take for granted that the medication they take is safe, pharmaceutical auditors work behind the scenes to make sure the drugs we use will not do us more harm than good. The International Society for Pharmaceutical Engineering offers training for Good Manufacturing Practice auditors in the form of classroom training courses that certify auditors.
The ISPE provides training to prepare GMP auditors to uphold the GMP rules and regulations developed by the U.S. Food and Drug Administration. The FDA created the GMP rules to protect consumers and they rely on GMP auditors to enforce those rules to assure that drugs and medications are safe, effective and pure. Typically, companies staff internal GMP auditors to keep themselves accountable to the FDA and their customers. Failure to keep GMP standards can mean massive fines, recalls and even jail time for company execs. ISPE auditor certification benefits new auditors, auditors looking for more experience in GMP auditing practices and other professionals who work with pharmaceutical companies, like suppliers and scientists.
An ISPE GMP auditor training course covers a variety of topics including auditing different areas of the business. The training classes show auditors how to assess a company’s recordkeeping systems, personnel, cleanliness, equipment and manufacturing processes. Other topics the class covers include GMP background information, audit preparation, conducting an audit and dealing with any issues the audit reveals. The class teaches auditors the skills needed to follow an audit checklist, create an audit report and understand compliance concepts.
The ISPE GMP auditor training courses take place in a classroom setting at various locations throughout the world. Typically, the ISPE will offer the GMP auditing course several times a year. For example, in 2013, the ISPE held its GMP auditing course in Indiana, New Jersey and Czech Republic. The course takes two days to complete and participants also receive 1.3 continuing education credit hours for finishing the class. Currently certified and training GMP auditors, who are also ISPE members, teach the classes.
The only two requirements for attending a GMP auditing class through ISPE is registering via the ISPE website and paying the class fee. ISPE offers a discount for its members, as well to federal government employees, students and professors. As part of the registration fee, participants get all the class materials, including workbooks, texts and study materials, as well as breakfast and lunch each day.
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