A Practical Approach to Microbial Data Deviation Investigations

Instructor: Frank Settineri
Product ID: 701129
Training Level: Intermediate to Advanced
  • Duration: 90 Min

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

Training CD

One CD is for usage in one location only.
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CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556


Read Frequently Asked Questions

This Pharmaceutical training will utilize the Aseptic Processing Guidance as a centerpiece for conducting MDD investigations and will supplement its proposals with additional industry-standard best practices.


The scope of the FDA guidance document on Out-Of-Specification results addresses analytical excursions, not microbiological excursions (Microbiological Data Deviations - MDD), although the approach for correcting them is the same: 1) Determine the root cause 2) Determine a corrective and/or preventative action and 3) Demonstrate that the corrective/preventative action was effective. Recent FDA warning letters cite microbiological excursions and many companies are unsure how to correct them since there are no definitive guidance’s. This webinar will utilize the Aseptic Processing Guidance as a centerpiece for conducting MDD investigations and will supplement its proposals with additional industry-standard best practices.

Areas Covered in the seminar:

  • What guidance documents govern microbiological data deviations (MDD).
  • What should we do about the specific batch and related batches of products when an MDD is found?
  • What is the difference between an objectionable microorganism and one that is pathogenic?
  • How do I determine the root cause?
  • How do I conduct a microbiological risk assessment?
  • How do I determine a corrective and/or preventative action?
  • How to I demonstrate that the corrective/preventive action was effective?
  • What can I do to minimize the reappearance of the excursion?

Who will benefit:

This webinar will provide definitive actions to follow when a microbiological data deviation (MDD) is encountered. It will allow the company to properly disposition its affected product(s) and will provide actions designed to prevent future occurrences. Employees who can benefit include:

  • Senior Management responsible for making final decisions
  • QA directors and managers
  • Microbiology analysts and technicians
  • Regulatory and Compliance Management
  • Consultants
  • 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 business 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 oversight of the industry that has benefited his clients, including major pharmaceuticals, start ups, laboratories and generic companies.

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