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FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials: 2-day In-person Seminar

ComplianceOnline

Monday, December 9, 2013 at 8:30 AM - Tuesday, December 10, 2013 at 3:30 PM (PST)

San Francisco, CA

FDA's GMP Expectations for Phase I and First-in-Man...

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Ticket Type Remaining Sales End Price Fee Quantity
Seminar Ticket 1 Ticket Ended $1,299.00 $48.92

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Share FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials: 2-day In-person Seminar

Event Details

Course Description:

Manufacturing an investigational product for the initial pilot clinical trials could pose a considerable logistical and financial challenge to developers. The first-in-man and pilot clinical trials are usually conducted in very small number of healthy participants with lower doses primarily to establish safety and hence do not need a significant amount of investigational material. The US FDA allows developers to test early stage investigational products under relaxed GMP requirements.

The manufacturing requirements for early stage clinical trials are designed to assure adequate quality of the investigational product being tested without the excessive regulatory burden of full-scale GMP manufacturing. This workshop will present the current regulations, guidance documents and regulatory strategies available for manufacturing an early development stage product for Phase I and first-in-man clinical trials. Also discussed will be logistical issues with managing the supply of an early stage investigational product, and requirements for stability testing, storage and shipping, labeling, and documentations. Issues specific to special products in early stages of development such as combination products and 505(b)(2) drugs will be discussed. Basics of process validation along to standard process development will be presented. Perspectives for different classes of products will be presented using case studies.

 

Who will Benefit:

  • Directors
  • Managers
  • Supervisors, and lead workers in Regulatory Affairs
  • Quality Assurance and Quality Control
  • Workers who will prepare GMP documents for early phase products as well as those who will review these documents
  • Regulatory affairs workers who will need to deal with submissions covering early phase products.

For Registration:

http://www.complianceonline.com/ecommerce/control/seminar?product_id=80039SEM&?channel=Eventbrite

Have questions about FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials: 2-day In-person Seminar? Contact ComplianceOnline

When & Where



Grand Hyatt San Francisco
345 Stockton Street
San Francisco, CA 94108

Monday, December 9, 2013 at 8:30 AM - Tuesday, December 10, 2013 at 3:30 PM (PST)


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Organizer

ComplianceOnline

At ComplianceOnline, we are focused on :

 

  • Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
  • Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
  • Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
  • Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.

 

 

 

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