Specification and OOS for Pharma, Biopharma and Combination Products
Website https://www.complianceonline.com/specification-oos-pharma-biopharma-combination-products-webinar-tra |
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Deadline: August 28, 2019 | Date: August 28, 2019
Venue/Country: U.S.A
Updated: 2019-08-15 01:52:28 (GMT+9)
Call For Papers - CFP
Stericycle Expert Solutions in their Q1 2019 Recall Index indicates, For the Eleventh consecutive quarter, failed specifications were the top reason for pharmaceutical recalls.For example, in this webinar, as a QA, Product Development, QC and Regulatory professional you will learn about what to look for in setting specifications for Drug Substance or Active Pharmaceutical Ingredients, Starting materials, Raw materials, Excipients and Final Product of small and or Biotechnology derived drug products.The overall goal of this course is to raise awareness for setting the right specifications for the drug product to improve patient satisfactions and to prepare organizations for regulatory inspections. The session provides quality assurance and product development professionals with a management perspective to make the right decisions in selecting the correct specifications.Emphasis is on higher level on how to prevent OOS, product recall, FDA and or other regulatory notifications due to specification failures, Patient Safety and Satisfaction.Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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