Course Description

Price:£735.00 (excl VAT-discounts may be available).This course is designed to give existing auditors, who have no ‘bio’ background, sufficient exposure to some of the specific issues involved in biologics and biotech processing to allow them to approach a biologics/biotech audit with confidence. GMP requirements of both EMA and FDA (CBER) are addressed. The course is ideal for delegates who have either previously attended NSF-DBA’s IRCA certified Pharmaceutical Quality Management Systems Auditor/Lead Auditor course, or who already have a good understanding of the basic principles and practices of auditing and wish to expand their technical understanding to biologics/biotech GMPs. The course can also contribute to registered auditors’ and lead auditors’ professional requirement for continuing professional development.This course will also be ideal for manufacturing and quality personnel already working in a biologics/biotech facility who wish to undertake effective self-inspection

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