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

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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Jun-2008

Training CD / USB Drive

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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 :
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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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