This course will review recent legislation enacted by key regulatory bodies including EMA, FDA, CFDA, ANVISA to ensure excipients are produced and supplied according to Good Manufacture Practice. The impact on excipient manufacturers, brokers and distributors will be reviewed along with the expectations of drug product license holders. This course will explain expectations for excipient risk analysis and how to adapt your company’s Vendor Management Program accordingly. The pharmaceutical industry often accounts for only a small proportion of an excipient manufacturers volume and often auditors need to work around time constraints. This course will cover good auditing techniques and strategies to overcome these constraints while meeting your company’s objectives.
What You Will Learn
Recent changes in legislation impacting excipient manufacture and supply:
Your Tutors: Luba Skibo and Janeen Skutnik
BY CHECK: Make payable to "NSF Health Sciences LLC" and mail to us at: NSF Health Sciences LLC, 129 South Street, Boston, MA 02111.
BY WIRE TRANSFER
Bank - JP Morgan Chase, New York, NY
ABA Number - 021000021
Account Name - NSF International 790465173
Swift Code - CHASUS33