Understanding the Current FDA Requirements for Raw Materials and Components

Speaker

Instructor: Jamie Jamshidi
Product ID: 701048

Location
  • Duration: 90 Min
This webinar will cover the current FDA requirement for raw materials used in producing APIs and drug products. Attendees will learn how to ensure that raw materials are of acceptable identity, quality and purity before use. This webinar will also provide best practices for avoiding FDA warning letters and 483 observations.
RECORDED TRAINING
Last Recorded Date: Dec-2014

 

$229.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$299.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

Why Should You Attend:

During the last several years, FDA has issued numerous observations and warning letters to pharmaceutical and biotechnology companies for lack of adequate systems for evaluating the suppliers of raw materials and the components, to ensure that these materials are acceptable for use. It is the FDA requirement that all raw materials that are received and used in producing APIs and drug products should be qualified using a system to ensure that raw materials are of acceptable identity, quality and purity before use.

Areas Covered in the Webinar:

  • Establish appropriate specifications for these materials and assure that your suppliers provide materials meeting these specifications.
  • Have the quality unit approve these specifications.
  • Ensure that raw materials received are suitable and approved by the quality unit prior to use.
  • Set a vendor qualification program that provides adequate evidence that the manufacturer can consistently provide reliable and safe materials.
  • Audit, monitor and regularly scrutinize the suppliers to assure ongoing reliability.
  • Review FDA 483s and warning letters related to this topic.

Who Will Benefit:

This training applies to personnel / companies primarily in the pharmaceutical, and biotechnology industries. The employees who will benefit include:

  • Senior Management
  • Regulatory Affairs Personnel
  • Quality Assurance Personnel
  • Production Staff
  • Engineering Staff
  • All personnel involved in an U.S. FDA-regulated environment

Instructor Profile:

Jamie Jamshidi, Biotech-Pharmaceutical Quality & Regulatory Advisor has over 27 years of industry experience, including small molecules and large molecule biologicals.

Jamie has a broad understanding of the entire drug development process for both large molecule proteins and small molecules. She has extensive knowledge of U.S. Regulatory Filings through product life cycle, FDA Current Good Manufacturing Practices (CGMP), Current Good Laboratory Practices (CGLP) and Current Good Clinical Practices (CGCP), European and Japanese drug manufacturing regulations, ICH guidelines, and Qualified Person (QP) requirements under EU Directives, and World Health Organization (WHO) regulations.

Jamie also has extensive experience in the development and commercialization of pharmaceuticals and biotechnology at all process stages, including Drug Substance (API), Drug Product, Packaging, and Labeling. She has given numerous lectures and talks in the areas of Quality and Regulatory in several colleges, universities and conferences globally. She is well known in bio/pharmaceutical industry for her passion and respect for laws and regulations in ensuring product quality.

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Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar 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 [email protected] call +1-888-717-2436 (Toll Free).

 

 

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