Understanding the Current FDA Requirements for Raw Materials and Components

Instructor: Jamie Jamshidi
Product ID: 701048
  • Duration: 90 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: Dec-2014

Training CD / USB Drive

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(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

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.

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.

Follow us :
Seminars by Ex-FDA Officials
Latin America: Regulatory Compliance Requirements for Life Science Products

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.

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