

# Event Details

- **Event Name**: Quality and GMP Compliance for Virtual Companies (Pharma, Med Device & Biologics Industries)
- **Event Start and End Date**: Wed, 18 Feb, 2026 at 09:00 am – Thu, 19 Feb, 2026 at 04:00 pm
- **Event Description**: For Agenda &amp; Event Registration Visit: https://www.complianceonline.com/fda-ema-inspection-gmp-gcp-qa-for-virtual-companies-seminar-training-80445SEM-prdsm?channel=alleventsUse coupon COMPLIANCE15 to get 15% discount on this virtual seminarAfter registration ComplianceOnline customer care will contact you on a day before the event with event link and proceedingsToday, 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.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 CanadaWho will Benefit:This course is designed for those charged with managing Quality Assurance and Regulatory Affairs for companies in the development or commercial phase of growth who either release investigational drugs to clinical trial sites or send commercial products to the market, but rely to a great extent on the use of Contract Manufacturers and/or Contract Laboratories. The following personnel will benefit from the course:Senior quality managers in manufacturing QA/GMP or clinical quality areasQuality professionalsRegulatory professionalsClinical OperationsCompliance professionalsQuality auditors – GMP and GCPDocument control specialists
- **Event URL**: https://allevents.in/sunnyvale/quality-and-gmp-compliance-for-virtual-companies-pharma-med-device-and-biologics-industries/80002751115305
- **Event Categories**: workshops, health-wellness, business, meetups, conferences, virtual
- **Interested Audience**: 
  - total_interested_count: 0

## Ticket Details


## Event venue details

- **city**: Sunnyvale
- **state**: CA
- **country**: United States
- **location**: MetricStream Inc.
- **lat**: 37.4180315
- **long**: -121.9791885
- **full address**: MetricStream Inc., 6201 America Center Dr, Sunnyvale, CA 94089, United States

## Event gallery

- **Alt text**: Quality and GMP Compliance for Virtual Companies (Pharma, Med Device &amp; Biologics Industries)
  - **Image URL**: https://cdn2.allevents.in/thumbs/thumb69428fa1789cb.jpg

## FAQs

- **Q**: When and where is Quality and GMP Compliance for Virtual Companies (Pharma, Med Device & Biologics Industries) being held?
  - **A:** Quality and GMP Compliance for Virtual Companies (Pharma, Med Device &amp; Biologics Industries) takes place on Wed, 18 Feb, 2026 at 09:00 am to Thu, 19 Feb, 2026 at 04:00 pm at MetricStream Inc., 6201 America Center Dr, Sunnyvale, CA 94089, United States.
- **Q**: Who is organizing Quality and GMP Compliance for Virtual Companies (Pharma, Med Device & Biologics Industries)?
  - **A:** Quality and GMP Compliance for Virtual Companies (Pharma, Med Device &amp; Biologics Industries) is organized by ComplianceOnline.
- **Q**: Who is this event for? Is it right for me?
  - **A:** Quality and GMP Compliance for Virtual Companies (Pharma, Med Device &amp; Biologics Industries) is ideal for professionals, entrepreneurs, startup founders, and networking enthusiasts eager to grow their connections. Whether you're a first-time attendee or a longtime enthusiast in Sunnyvale, this event is thoughtfully curated to deliver a standout experience worth every moment. If Quality and GMP Compliance for Virtual Companies (Pharma, Med Device &amp; Biologics Industries) sounds like your kind of event, don't wait - spots fill up fast.

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