Live: One Dial-in One Attendee
Corporate Live: Any number of participants
Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
GMPs for Excipients is a developing area. There is no US or other geographical jurisdiction regulation covering this area.
Trade groups have issued GMPs and guidance documents and the regulators expect the pharmaceutical manufacturers to monitor excipient manufacturers, and all of the elements of the excipient supply chain to have appropriate controls in all of the areas found in the drug GMPs: organization, personnel, buildings, facilities, equipment, components, production, production controls, packaging, labeling, laboratory testing, and documentation, and assure that they demonstrate good manufacturing practices through the implementation of contemporary quality systems such as outlined in ICH Q10, Pharmaceutical Quality System.
A focus of the regulators is the use of risk management , as outlined in ICH Q9, Quality Risk Management, to identify potential problems and develop appropriate corrective and preventive actions.
Why should you Attend: This 90 minute webinar, “GMP Compliance for Excipients”, provides an understanding of Regulatory expectations and concerns for the production and control of drug product excipients.
Although the regulators may not have a direct responsibility for monitoring Excipient manufacturers, they do expect the drug product manufacturers to implement appropriate controls over excipient manufacturers and the production and control of pharmaceutical product excipients.
Pharmaceutical product producers monitor and control excipient manufacturers from pharmaceutical product development through routine production to ensure that the excipient has implemented appropriate GMPs and quality systems.
Areas Covered in the Session: This webinar will focus on the five key areas of GMPs: