Validation Requirements Based on ICH Q9

Speaker

Instructor: Jamie Jamshidi
Product ID: 700932

Location
  • Duration: 90 Min
This program is specially designed for personnel in the Pharmaceutical and Biotechnology industries. This guidance provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality.
RECORDED TRAINING
Last Recorded Date: Jul-2008

 

$249.00
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)

$500.00
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)

 

 

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Read Frequently Asked Questions

This guidance provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. These aspects include development, manufacturing, distribution, inspection, and submission/review processes throughout the lifecycle of drug substances, drug products, biological and biotechnological products (including the use of raw materials, solvents, excipients, packaging and labeling materials in drug products, biological and biotechnological products) Detail review of Quality Risk Management as Part of Production and Validation.

Areas Covered in the Webinar:

  • Understand why the use of Risk Management in Process Validation is now expected.
  • What does the FDA expect for batch conformance prior to, and post, product approval .
  • What is the benefit of using the Risk Management approach versus the traditional 3 batch validation approach?
  • What does ICH Q9 mean with respect to Quality Risk Management in Validation.
  • Learn why the Quality Risk Management approach to Validation will result in less ongoing process support during production.

Who will benefit:

This program is specially designed for personnel in the Pharmaceutical and Biotechnology industries with daily responsibilities in the:

  • Quality Assurance
  • Regulatory Affairs
  • Compliance Auditing
  • Validation
  • Manufacturing
  • Consultants
  • Training
  • Quality Control
  • Product Submission

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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