This Quality by Design (QbD) webinar training will discuss what the agency is looking for and how to build a relationship with regulators by following certain dos and don’ts.
Why Should You Attend:
Quality by Design (QbD) is an FDA initiative that has been in existence for more than 5-6 years. Success has been evident in the generics and drugs areas but now beginning to be evident in the biologics area. This has resulted in improved science and more trust and openness between industry and FDA in the 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.
This webinar will describe the origins and rationale for the QbD program. It will describe the successes in the generics 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.
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 is useful for all companies in pharmaceutical and biotech industries. All staff from following department must attend this course
- Quality and Compliance
- Process development
- Regulatory Affairs
- Manufacturing
- Validation
- Project managers
- Drug Safety
Instructor Profile:
Peter Calcott, Ph.D. is founder and President of Calcott Consulting which serves the biotech, pharma and venture capital industry. It provides consulting services in supply chain, quality systems, clinical development, regulatory affairs, compliance and governance, enterprise e-solutions and government affairs. It also provides corporate strategy development, analysis and assessment especially due diligence evaluation.
He has held positions in industry in all these disciplines over a 30 year career. He has presented at national meetings and is active in the biotechnology community via BIO and the bay area BayBio trade associations where he is chairman of the BIO RAC committee and a Board member of BayBio.
