Dublin, Oct. 10, 2019 (GLOBE NEWSWIRE) -- The "Quality and GMP Compliance for Virtual Companies (Pharmaceutical, Medical Device & Biologics Industries)" conference has been added to ResearchAndMarkets.com's offering.
Today, many companies operate on an outsourcing model. This is very common for companies who are evolving from being mainly development-focused to a point where they are entering latter stages of Phase 2 or Phase 3 clinical trials, and plan to have a product ready for market approval in the coming months. Most such companies are small, and may not have deep expertise in QA and GMP compliance, relying on their partners to cover those areas.
Companies who outsource the majority of operations through the use of Contract Manufacturing Organizations (CMOs), Contract Research Organizations (CROs) and Contract Laboratories, however, remain responsible for the quality and compliance status of the products they send to the clinic or to the marketplace.
The Event
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.
You will also learn best practices for managing a regulatory inspection, with emphasis on FDA, EMA and Health Canada, but applicable to most other major agencies as well.
Learning Objectives
Participants in this seminar will:
Who Should Attend?
Agenda
Day 1
08.30 AM - 09.00 AM: Registration
09.00 AM: Session Start
Introductions and participant expectations for the program
Fundamentals of Good Manufacturing Practice
Data Integrity: What it is and why it is important to GMP
Fundamentals of Good Clinical Practice (GCP)
Regulatory and business risks: The case for compliance
Virtual company organizational structure and responsibility for QA/GMP/GCP
Virtual company quality system structure and management
Selection, qualification and monitoring of contractors
Day One Q&A and recap of progress meeting stated course expectations
Day 2
Regulatory Inspections
Logistics for managing inspections at your location
Inspections at your contract organizations
Post-inspection communications with the inspecting agency
Enforcement considerations
Final Q&A, discussion, and conclusion
4:30 PM: Adjourn
For more information about this conference visit https://www.researchandmarkets.com/r/lpbmgj
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