Quality and GMP Compliance for Virtual Companies (Pharmaceutical, Medical Device & Biologics Industries)

ComplianceOnline, Virtual Seminar
February 18-19, 2026

Use coupon COMPLIANCE15 to get 15% discount on this virtual seminar

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:

• 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:
  • Inspection logistics
  • Responding effectively to document requests and questions from inspectors
  • Managing 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

Kevin J Slatkavitz, Ph.D President & Founder, ThinkQuality, LLC

KEVIN J. SLATKAVITZ, Ph.D. is the President & Founder of ThinkQuality, LLC, a results-oriented consulting firm providing clients across the life sciences with practical strategies, fit-for-purpose solutions, and hands-on support based on real world boots-on-the-ground experience to navigate a wide array of quality and GXP compliance challenges and opportunities in fast-paced environments.

Dr. Slatkavitz has 30+ years’ experience working proactively and collaboratively for virtual, mid and large companies and with CROs/CMOs/Business Partners to build quality and compliance into the drug development, manufacturing and supply chain processes resulting in measurable business success – including regulatory approvals and inspections. He has served as Head of Quality and other senior leadership roles in the pharma/biotech industry and is very passionate about enabling compliance with a science-based risk management approach.

Dr. Slatkavitz holds a BS in Chemistry from Tufts University and a Ph.D. in Analytical Chemistry from the University of Massachusetts Amherst. He is vested in collaborating with industry, academia, and regulators to advance quality and compliance best practices.   

Use coupon COMPLIANCE15 to get 15% discount on this virtual seminar. Register by following this below URL