ComplianceOnline

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

Instructor: Peter Calcott
Product ID: 700893
  • Duration: 60 Min

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

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.

Description

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.

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.

Follow us :
ComplianceOnline Banking Summit 2016 | Risk Management and Data Security - 80390SEM
ComplianceOnline Medical Device Summit 2017

Product Reviews

This product hasn't received any reviews yet. Be the first to review this product! Write review

Best Sellers
You Recently Viewed
    Loading