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PDA New England Chapter Webinar: Avoiding Adverse Findings in FDA Inspections

Aug 05, 2020
2:00 PM
-
3:00 PM
| Eastern Standard Time
Online
  • Chapter
  • Online
Register Now

Overview

In this webinar Jeanne Moldenhauer will highlight various inspection trends by FDA and how this information can be used to aid in preparation for upcoming inspections. The focus is how to present adverse findings in an inspection. She will review top inspection items for the last five years and key warning letter observations for the last four years.

Agenda

  • Key Discussion Topics:

    • Things to do before the inspections
    • FDA Expectations during the inspection
    • What to do after the inspection

Highlighted Speakers

Jeanne Moldenhauer
Jeanne Moldenhauer
Excellent Pharma Consulting, Inc.
Bio
Jeanne Moldenhauer
Excellent Pharma Consulting, Inc.

Jeanne Moldenhauer, Excellent Pharma Consulting has more than 25 years experience in the pharmaceutical industry. She chairs the Environmental Monitoring/Microbiology Interest Group of PDA, serves on the Scientific Advisory Board of PDA, founded the Rapid Microbiology User's Group™, and is a member of ASQ and RAPS. She is the author of Steam Sterilization: A Practitioner's Guide, Laboratory Validation: A Practitioner's Guide, Environmental Monitoring: A Comprehensive Handbook, System's Based Inspections for Pharmaceutical Manufacturers, co-author of Biological Indicators, and numerous publications.

Who Should Attend

  • Quality Control
  • Quality Assurance
  • Quality Systems
  • Regulatory / Compliance
  • Facilities
  • Manufacturing

Registration Fees

Register Now
Registration Type Price
Member* $25.00
Non-Member $65.00

*A special discount is available for PDA Members. To get this discount code, send an email to PDA Membership Dept: [email protected] or Shanna Morgan, [email protected].

NOTE: When entering a discount code, ensure that all characters are in UPPER case, when applying. Do not cut & paste.

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