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Validity : 14th Apr'24 to 24th Apr'24
GMPs for Virtual Companies
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.