ANDA Submission and GDUFA Guidance

Instructor: Charles H Paul
Product ID: 706538
Training Level: Intermediate
  • Duration: 60 Min
In order to properly, effectively, and efficiently bring generic drugs and medicinal products to market, it is crucial to anyone interacting with the submittal process to understand how the process is structured and functions
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Why Should You Attend:

In addition, with the passage of GUFDA II which significantly changes the fee structure, it is also crucial to understand the major changes to the program, and the effects of those changes on the generics industry.

This webinar explains the submittal process of drugs and medicinal products and also explores the GUFDA II Guidance.

Areas Covered in the Webinar:

  • Overview of the ANDA and PAS processes
  • Overview of GDUFA
  • The FDA’s process for classifying major, minor, and unsolicited amendments to ANDAs or PASs.
  • How ANDA or PAS deficiencies that will cause the FDA to request a major amendment or classify deficiency responses as a major amendment.
  • The amendment format and submission process.
  • The FDA's review goals for amendments under GDUFA II.
  • How the FDA will process amendments submitted before GDUFA II.
  • How to request that the FDA reconsider classifying a major amendment.
  • A discussion of how high quality standards are maintained through inspections and risk-based approaches.
  • The process of and reasons for requiring the identification of the facilities involved in the manufacture of generic drugs and the associated active pharmaceutical ingredients.
  • The intent of the FDA to expedite product access.
  • How amendment submissions may affect review goal dates.

Who Will Benefit:

The audience for this webinar would consist of anyone in the generic pharma business in the following functions:

  • Compliance and regulatory,
  • Research & development,
  • Quality assurance. Positions would include – Director, Associate Director, Manager, and associates
Instructor Profile:
Charles H Paul

Charles H Paul
President, C H Paul Consulting Inc

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence. He is a regular presenter of webinars and on-site seminars in a variety of related subjects from documentation development to establishing compliant preventive maintenance systems. The firm works globally completing projects throughout the EU, UK, South America, and Asia.

Follow us :
Raw Material Requirements
Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)

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.

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