Quality by Design - Integrating your product and process development into your submission with QbD

Instructor: Peter Calcott
Product ID: 701525
  • Duration: 60 Min

recorded version

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
Last Recorded Date: Feb-2010

Training CD / USB Drive

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

Customer Care

Fax: +1-650-362-2367


Read Frequently Asked Questions

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.

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Seminars by Ex-FDA Officials
Upcoming In-person Seminars by EX-FDA OFFICIALS

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 call +1-888-717-2436 (Toll Free).

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