Auditing and Compliance of Biopharmaceutical API Facilities

Speaker

Instructor: Frank Settineri
Product ID: 701208
Training Level: Intermediate to Advanced

Location
  • Duration: 90 Min
This FDA audit training will review the fundamental aspects of auditing biopharmaceutical API facilities to ensure their compliance with current regulatory guidelines.
RECORDED TRAINING
Last Recorded Date: Apr-2009

 

$149.00 $249.00 (40%)SAVE: $100.00
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)

$229.00 $299.00 (23%)SAVE: $70.00
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

Biopharmaceutical Active Pharmaceutical Ingredients (APIs) must be produced according to Good Manufacturing Practices outlined in FDA and ICH guidelines in order to be marketed to the public. This webinar will review the areas that an inspector may examine when conducting an audit of a biopharmaceutical API supplier to ensure it complies with regulatory requirements.

Areas Covered in the seminar:

  • Review of applicable regulatory guidelines that oversee the manufacturing of Biopharmaceutical APIs.
  • What are the GMP requirements I need to know?
  • What are the specific guidelines for APIs manufactured by cell culture/fermentation?
  • What are the requirements for cell bank maintainence and record keeping?
  • What are the requirements for cell culture/fermentation?
  • What are the requirements for harvesting, isolation and purification?
  • What are the requirements for viral removal/inactivation steps?

Who will benefit:

This webinar will review the fundamental aspects of auditing biopharmaceutical API facilities to ensure their compliance with current regulatory guidelines. Employees who can benefit include:

  • Senior Operations and Quality Management
  • QA directors and managers
  • Production management, supervisors and operators
  • Regulatory and Compliance Management
  • Laboratory management and analysts
  • Quality system auditors

Instructor Profile:

Frank Settineri, is the founder and President of Veracorp LLC, a consulting firm that specializes in providing pharmaceutical, biotech, medical device and startup companies with the essential advice they need to keep their businesses running efficiently and within regulatory guidelines. With over 30 years of pharmaceutical business, manufacturing and laboratory experience he is an authority on FDA Warning Letters and 483s, GMP compliance, validation planning, outsourcing, microbiology, sterile and non-sterile manufacturing issues. His accomplishments in science (setting up and running laboratories), compliance (auditing, validation, and outsourcing) and business (building a start-up pharmaceutical company and its infrastructure) endow him with a unique over site of the industry that has benefited his clients, including major pharmaceuticals, start ups, laboratories and generic companies.

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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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