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Quality and GMP Compliance for Virtual Companies (Pharmaceutical, Medical Device & Biologics Industries)
Website https://www.complianceonline.com/fda-ema-inspection-gmp-gcp-qa-for-virtual-companies-seminar-trainin |
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Category Pharmaceutical; Medical Device; Biologics Industries
Deadline: February 18, 2026 | Date: February 18, 2026-February 19, 2026
Venue/Country: U.S.A
Updated: 2025-11-06 16:35:05 (GMT+9)
Call For Papers - CFP
In this two day workshop conference you will learn the requirements and expectations of major health care regulators that are applicable to "virtual" companies. You will learn how to diagnose your company's needs based on which GMP and GCP-governed operations you retain and which you outsource; what the current expectations and best industry practices are for selecting, qualifying and monitoring your contractors to ensure they are meeting your requirements; and how to build a quality system framework that is not excessive for your current needs, but has the structure and integration to "grow with you" as the scope your operations change in the coming months and years.Learning Objectives:Participants in this seminar will:Understand the GMP and GCP requirements all virtual companies must meet regardless of the extent of their outsourcing operationsUnderstand how to select, qualify and monitor CMOs, CROs and Contract LaboratoriesLearn the elements to include in a quality agreement (also known as a technical agreement)Learn how to determine which GMP or GCP requirements apply to you, depending on the things you do internally and those you outsourceUnderstand your obligations under the law for products you release to the clinic or the marketplaceAppreciate the importance of maintaining data integrityLearn how to effectively manage a health regulatory inspection:Inspection logisticsResponding effectively to document requests and questions from inspectorsManaging the inspection exit discussionHow to write an effective response to inspection observationsHow to find applicable inspection references and procedures of the FDA, EMA and Health CanadaKeywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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