Ensuring the Microbiological Integrity of Pharmaceutical and Biopharmaceutical Facilities

Instructor: Frank Settineri
Product ID: 701145
Training Level: Intermediate to Advanced
  • Duration: 90 Min
This Microbiology training/webinar will provide a new approach in ensuring the Microbiological Integrity of Pharmaceutical and Biopharmaceutical Facilities.

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: May-2009

Training CD / USB Drive

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

Customer Care

Fax: +1-650-362-2367

Email: customercare@complianceonline.com

Read Frequently Asked Questions

Pharmaceuticals and biopharmaceuticals are products that are designed to make people well. Therefore it is incumbent upon manufacturers to ensure these products are manufactured in a manner that ensures their microbiological integrity. Achieving this goal requires a few simple activities: maintaining a clean facility, selecting the right people and training them to be constantly aware of their microbiological footprint. Companies that adhere to these principles will not only be close to being compliant with regulatory requirements but will also promote the health of patients who use their products.

Areas Covered in the seminar:

  • Overview of Microbiological Integrity.
  • Expectations of cGMPs.
  • Microbial Integrity: Cleanliness.
  • Microbial Integrity: People.
  • Microbial Integrity: Training.
  • Microbial Integrity: Compliance.
  • Case Studies.
  • Specific actions to ensure microbiological integrity.
  • Making microbial integrity pay for you.

Who will benefit:

  • End-users responsible for applications that need to be validated
  • QA managers and personnel
  • Information Technology managers and personnel
  • Validation specialists
  • Quality system auditors
  • Consultants

Instructor Profile:

Frank Settineri, is the founder and President of Veracorp LLC, a consulting firm that specializes in providing pharmaceutical, biotech, medical device and start up companies with the essential advice they need to keep their busineses 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, outsourcing) and business (building a start-up pharmaceutical company and its infrastructure) endow him with a unique oversite of the industry that has benefited his clients, including major pharmaceuticals, start ups, laboratories and generic companies.

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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.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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