Why Should You Attend:
The ICH and FDA guidance documents on Pharmaceutical cGMPs stress the importance of management's responsibility to meet customer needs by encompassing quality improvement through quality by design (QbD), risk management, process control, and user feedback and experience.
This new paradigm forces industry leaders as well as the FDA to rethink their roles in this dynamic regulatory-business environment. Here, quality principles trump the dictates of compliance. If your company fails to respond to this new calling, it may not be able to compete effectively in the marketplace. These quality concepts are based on well-known and tested quality principles that have been shown to be effective. While the "new quality" is gaining, the virtues of compliance are declining.
Attend this 4-hour webinar and learn how you can successfully implement the Quality Systems Approach in your operations. Understand how you can be an active and positive force in driving this paradigm change at your organization.
Areas Covered in the Seminar:
Who Will Benefit:
Because these guidance documents focus on management's responsibility to organize for quality and manage resources, all functions are impacted directly or indirectly. Therefore , all departments would benefit from the seminar. Below is a list of functions that would benefit from attending:
Howard, enjoys sharing his 30 years plus experience in starting up, developing, implementing, managing, and remediating pharmaceutical and medical device quality systems. He has a BS in Biology/Chemistry and Political Science as well as work toward an MBA. His ability to quickly learn the technology is demonstrated by his success in applying quality assurance principles to a wide range of pharmaceuticals and medical devices. He is a Certified Biomedical Auditor (CBA), Certified Quality Manager (CQM), and Quality Auditor (CQA). His technical education is further complemented by his Political Science degree helping him understand the regulatory process; his work toward an MBA provides business insight.
He is a member of ASQ, PDA, AAMI, RAPS, and SQA. He strongly believes that Quality is very influential in shaping successful operations. He knows how to use his leadership abilities to build organizational relationships that make systems operate effectively as well as to develop and empower people.
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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
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