Quality by Design: what the FDA wants, what you must do, how you can deliver to their expectations and what relief you can expect

Quality by Design (QbD) is an FDA initiative that has been in existence for upwards of 5 years. Success has been evident in the generic and drugs areas but less so in the Biologics. This has resulted in improved science in the generics industry and more trust and openness between industry and FDA in the drug industry. Much can be learned from the generics and drugs industries for the biologics industry. The results could be some startling reduction in regulatory burden and more streamlined operations. The fruits of the program can bring a higher success rate in the commercial operations with its impact on cost of goods, reduced reporting requirements or at least a reduction in the level of reporting for supplements and less complex or stressful inspections.

Areas Covered in the seminar:

• Why was QbD developed? And who will benefit?
• What must you supply to gain benefit?
• Can we submit materials retroactively for established products as well as new submissions?
• Why have previous submissions not met the QbD objective?
• How do you spell "regulatory relief"?
• Simpler inspections, reduced reporting requirements and more freedom to operate.
• Building trust between you and regualtors.
• Higher success rates in the plant.

Who will benefit:

This webinar will describe the origins and rationale for the QbD program. It will describe the successes in the generic and drug areas and the opportunities in the biologics areas. It will describe what the agency is looking for and how to best build the relationship with the regulators to maximize return on investment.

• QA and Complaince staff
• Process development staff
• Manufacturing staff
• Validation
• Regulatory affairs staff
• Project managers

Instructor Profile:
Peter Calcott, Ph.D. is the President of Calcott Consulting, a consulting firm focused on supply chain, quality, clinical development, regulatory affairs and corporate compliance. He has over 30 years experience in the industry having positions in Quality, manufacturing, process development, compliance. He has worked for large Pharma as well as small biotechnology companies. He has licensed and introduced new products to the marketplace on 6 continents.

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