Understanding FDAs Governance of Prescription Drug Development: Manufacturing/cGMPs, Submission Process and Post Approval Commitments - Part 2

  • Sharon W Ayd
  • 25, September 2019 Wednesday
  • 10:00 AM PDT | 01:00 PM EDT (60 Min)

Attend this webinar to explore the major considerations that must be planned before the prescription drug development process, the FDA cGMPs and their significance to drug manufacturing, the submission process and post-approval obligations. This session is part 2 of a 2-part series.

Live Online Training
September 25, Wednesday 10:00 AM PDT | 01:00 PM EDT (60 Min)

$229.00
One Dial-in One Attendee
$599.00
Group-Max. 10 Attendees/Location
(For multiple locations contact Customer Care)

Recorded Version Only

(PPT + Recorded Streaming Link)

$299.00
1x Person - Unlimited viewing for 6 Months (For multiple locations contact Customer Care)
rec Recorded Link and Ref. material will be available in My Account Section 48 hrs after completion of Live training

CD or USB Drive Only

(PPT + Recorded Training File)

$399.00
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(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days after completion of Live training
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Why Should You Attend:

Unless Pharma companies understand what regulations exist and how to turn them into effective internal compliance strategy, they cannot be successful. This webinar will assist in understanding the following pointers critical to success:

  • What you should be prepared for in the prescription drug development process
  • How you can ensure your analytical chemists and formulators have the right skill sets to develop a stable product formulation
  • How you can ensure your staff have experience in technology transfer from bench to manufacturing plant
  • The timeline for FDA drug development application review
  • What FDA will review in your application
  • Why the sponsor should honor post-approval obligations
  • What happens if the sponsor does not abide by the post-approval obligations?
  • This webinar will cover in detail all the key aspects of prescription drug development including API,

Drug Formulation, Analytical Characterization, Clinical Development, Technology Transfer and Target Product Profile. Although deciphering all the information and knowledge obtained during product development into batch records relevant for tech transfer to a manufacturing plant is complex, it is an essential aspect. This webinar will help you build a thorough appreciation for the intricacies of FDAs cGMPs, the regulations that govern drug manufacturing. The webinar will also explore the process of putting together an application for submission to FDA for review.

Areas Covered in the Webinar:

This webinar will talk focus on:

  • Important considerations that matter during prescription drug development process including: API characteristics, Drug Formulation Properties, Dose, Strength and Presentation, Analytical Characterization, Technology Transfer and Target Product Profile
  • What are some of the tradeoffs that must be made to obtain a stable product formulation?
  • Why does technology not always scale easily?
  • What are cGMPS and why do they matter so much
  • How is all the information developed during product development collected and organized into a submission to FDA
  • How long does it take for FDA to review my application and should I expect a first pass approval?
  • Now that FDA has approved my application, why do I have to make post-approval commitments
  • What are the consequences of not living up to post-approval commitments
Who Will Benefit:

This webinar will be invaluable to a wide-ranging audience composed of companies involved in drug research and drug development/commercialization this includes Pharmaceutical and Biotech companies, Academia, Clinical Research Organizations (CROs), Government sponsored groups and Not-for-Profits.

This webinar will be well suited to anyone needing practical knowledge or even a refresher. This webinar is applicable to all functions involved in developing drugs

  • Regulatory Function: Regulatory Affairs Associates, Regulatory Affairs Managers, Document Reviewers and Publishers
  • Research & Development Function: Staff scientists, Researchers, Formulators, Analytical Chemists, R&D Group Leaders, Laboratory Managers, R&D Supervisors, R&D Managers
  • Clinical Function: Statisticians, CRO employees, Clinical Study Monitors, Clinical Research Program Managers
  • Quality Function: Batch record reviewers
  • Marketing Function: Marketing Communications Manager
Instructor Profile:
Sharon W Ayd Sharon W Ayd

CEO, Ayd BioPharma Consulting Group

Sharon Ayd, is the primary owner and Principal Consultant at Ayd BioPharma Consulting Group, ("Ayd Group"). Sharon is a biopharmaceutical industry veteran with more than 30-years’ experience in developing and commercializing all types of prescription drugs, i.e., Branded/Novel, Specialty, Rare/Orphan, Generic, Biosimilar and combination products (drug/device). She has an established record of value creation for Life Sciences companies by; leading international drug programs from discovery through clinical evaluation, regulatory review/approval process, product launch and lifecycle maintenance. She is also recognized for helping companies become more profitable by optimizing business strategy as well as organization structure and operations.

Sharon worked for global and multi-national companies including Apotex Inc., Hospira (now Pfizer) and Fresenius Kabi. Her experience is not only scientific, but strategic and operational as well. She spearheaded Apotex’s first operational presence in US. At Hospira she was instrumental in building operational infrastructure, including Stage-Gate portfolio governance. As a member of the deal team, she integrated global R&D operations following acquisition of Bresagen and Mayne Pharma in Australia and Orchid Pharma in India. She also led One2One, Hospira’s branded CDMO where she had P/L responsibility. At Fresenius Kabi she led a fully integrated biopharma organization, on four continents with responsibility for an R&D pipeline of ~$2.5 Billion to the US Sales & Marketing Territory alone.

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. FDATrainingAlert 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@fdatrainingalert.com call +1-888-771-6965 (Toll Free).

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