Date: | March 29, 2017 - 1:00pm - 2:30pm |
Timezone: | (GMT-05:00) Eastern Time (US & Canada) |
Location: | AtoZ Compliance. 2754 80th Avenue, New Hyde Park, NY, 11040, United States |
Website for Event: | https://www.atozcompliance.com/trainings-webinar/life-sciences/pharmaceuticals/r... |
Topic: | Health Education |
Description: | Key Take Away : This webinar will present a unique perspective on risks associated with extractables, leachables & elemental impurities (ELEI) in cGMP manufacturing of pharmaceutical, biologic and medical device products. Overview : This pharmaceutical risk assessment webinar for quality risk management in pharmaceutical industry will start with a definitional review of risk management in pharma and then present the current FDA perspective on 1099 risk mitigation of impurities of these types in product. After the credit risk mitigation introduction, the instructor will present quality and compliance considerations related to ELEI. What will make this webinar unique is the presentation of three distinct case studies related to a project manager’s perspective of ELEI. The first involves a large blood fractionation facility and the successful implementation of a materials management program Why Should You Attend : This HIPAA risk analysis, risk assessment and HIPAA security risk assessment webinar is daunting to many outside of the laboratory setting. For most in the drug treatment manufacturing world, the chemistry involved/ risk based internal audit is not part of their vocabulary, nor should it be. An attendee of this webinar will be given a strong understanding of risk management corporate governance, but more importantly, be given the talking points to be able to add value to the conversation. This risk management for corporate leader’s webinar will leave attendees confident that they could support a project related to risk analysis, risk mitigation techniques or deviation resolution related to extractables, leachables & environmental impurities, with a basic understanding of the regulatory importance to cGMP manufacturing, and some memorable lessons learned that they can refer to throughout their career. Areas Covered In This Webinar : Introduction of the Topic Learning Objectives : Understand the importance of the topic Who Will Benefit : Anyone involved in the Direct Manufacturing or Manufacturing Support of Pharmaceuticals, Biologics or Medical Devices For more information, please visit : https://www.atozcompliance.com/trainings-webinar/life-sciences/pharmaceu... Level: Speakers Profile : Mr. Gibbs is a sought after trainer and educator who has a gift for motivating fellow professionals to reach their peak performance. Through many years of in the field experience, he possesses a full and applied understanding of the business of consultancy support to industry. |
Contact Name: | AtoZ Compliance |
Contact Email: | referrals@atozcompliance.com |
Contact Phone: | 8444141400 |