Auditing an Active Pharmaceutical Ingredient (API) Contract Manufacturing Organization (CMO)
Instructor:
Jamie Jamshidi
Product ID: 701065
- Duration: 90 Min
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
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.
Refund Policy
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).
