ComplianceOnline

Auditing an Active Pharmaceutical Ingredient (API) Contract Manufacturing Organization (CMO)

Instructor: Jamie Jamshidi
Product ID: 701065
  • Duration: 90 Min

recorded version

$329.00
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

Training CD

$499.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This webinar will discuss in detail key auditing elements of an Active Pharmaceutical Ingredient (API) facility/operation. It will cover selection, designation and documentation of starting materials; qualification of analytical methods; control requirements for multi-product/multi-processing API production facility; QA review and release of API and much more.

Why Should You Attend:

This webinar will detail step by step itemization of key auditing elements of an API facility/operation. It will include major’s item to look for during the audit of an API CMO. For example: selection, designation and documentation of starting materials; considerations for a chemical production facility such as process and material flows; qualification of analytical methods; requirements for intermediates testing, hold steps and release; and control requirements for multi-product/multi-processing API production facility; QA review and release of API; Quality systems; and Supplier qualification.

Areas Covered in the Webinar:

  • Review and discuss all audit elements for small molecules API facility/CMO.
  • Using the FDA Compliance Program Guidance Manual.
  • 7356.002F-Process Inspection additional items through our experience and knowledge.

Who will benefit:

This webinar will provide valuable assistance to all personal in the API Pharmaceutical industries. Personnel from the following functional areas will benefit from this course:

  • Quality Audit
  • Operations
  • QA/QC
  • Contract Manufacturing
  • Regulatory
  • Managements

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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