GMPs for Virtual Companies

  • 11
  • July 2023
  • 10:00 AM PDT | 01:00 PM EDT

    Duration:  90  Mins


Basic & Intermediate & Advanced

Webinar ID



Quality and Supply Chain Oversight for Virtual Companies – what is different and what are the Challenges?

  • What does quality oversight mean and what is expected?
  • What aspects of the supply chain are relevant and how is sufficient oversight achieved.
  • How to handle more than one quality System.
  • How to manage differences in culture and language.

Specific Quality System Aspects for Virtual Companies

  • General principles relating to virtual company quality Systems and how they should interact with other companies QMS.
  • Detailed review of likely points of interaction (e.g. Change controls, deviations/non-conformances, complaints & recall, preparation of the Product Quality Review, audits……)
  • How to ensure effective and efficient interaction and communication.
  • What are the challenges to overcome?

Batch Certification – Minimum Requirements & Best Practices

  • Manage deviation reporting and change control implementation in virtual companies.
  • Batch Certification – Considerations for Outsourcing.
  • Case studies, examples of effective arrangements.

Use of Quality Risk Management

  • Objective of QRM and how best to use this tool.
  • When to use proactively and how to ensure this is effective.
  • Examples of when QRM has to be used reactively and how to make informed, scientific decisions.

Post Product Release Oversight Responsibilities

  • Virtual companies’ responsibilities after certification and release of medicinal product.
  • Establishing arrangements for effectively managing defect reporting, potential market actions, supervisory authority engagement.

Overview of the webinar

Participants in this seminar will:

  • Understand the GMP and GCP requirements all virtual companies must meet regardless of the extent of their outsourcing operations.
  • Understand how to select, qualify and monitor CMOs, CROs and Contract Laboratories.
  • Learn 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 outsource.
  • Understand your obligations under the law for products you release to the clinic or the marketplace.
  • Appreciate the importance of maintaining data integrity.
  • Learn how to effectively manage a health regulatory inspection.

Who should attend?

  • Analytical Development.
  • Quality Assurance.
  • Quality Control.
  • Validation.
  • Regulatory Affairs.

Why should you attend?

You should attend the webinar to learn how to: 

  • Inspect logistics.
  • Respond effectively to document requests and questions from inspectors.
  • Manage the inspection exit discussion.
  • How to write an effective response to inspection observations.
  • How to find applicable inspection references and procedures of the FDA, EMA and Health Canada.

Faculty - Ms.Kelly Thomas

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation,  21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

What if you miss the Live Webinar?
Don't worry! Pay only $29 & get the full Recording.


Refund / Cancellation policy
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