GMP Investigations

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    Speaker: William Miller

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    Duration: 60 Minutes
    Product Code: 50095
    Level: Intermediate


This webinar will concentrate on the key attributes of an effective cGMP investigation, the role of management, quality control tools, CAPA effectiveness and Warning Letters associated with cGMP compliance. Attend this training and learn how you can avoid “Inadequate investigations”

“Any unexplained discrepancy or the failure of a batch or any of its components to meet any of its specifications shall be thoroughly investigated. A written record of the investigation shall be made and shall include the conclusions and follow-up.”

  • 21CFR Part 211.192.

Implementing an effective system of conducting investigations that, ensure compliance of the five manufacturing systems: production, facilities and equipment, laboratory controls, materials, packaging and labeling and the overarching quality system is a critical requirement for the manufacture and sale of all FDA regulated products.


Any FDA inspection will ask to review your complaints, investigations and recalls. This, with a tour will be their first impression of your organization’s state of compliance. The investigations you performed for unexplained discrepancies and complaints will need to stand alone for an inspector to read and understand. They can and will ask questions for clarification but minimizing the number will not sidetrack their focus. 

In a list of top ten reasons for FDA form 483s, investigations discrepancies, failures were number two.

Effective and repeatable failure investigation and root cause analysis is still not the industry norm.

This webinar will discuss the keys to an effective cGMP investigation, the role of management, employing quality tools, root cause determination and CAPA effectiveness checks.

Unexplained discrepancies and failures will occur; effective investigations and CAPAs ensure they do not reoccur.


This webinar will give you a process to establish an effective system of conducting investigations. This includes:

  • Why an investigation?
  • What is an effective investigation system?
  • 21CFR Part 211.192 Requirements
  • Steps to follow to conduct a thorough investigation.
  • Root Cause versus symptoms of an unexplained discrepancy
  • Methods to determine root cause
  • Historical review’s role in investigations
  • CAPA’s role in investigations
  • Creating a culture of compliance in your organization


  • The benchmarks and best practices for writing thorough and compliant investigations.
  • How to determine your organization’s current investigation effectiveness.
  • Provide a template that will enable managers and supervisors to write effective investigations.
  • Timeliness – How to meet both the compliance and customer impact to your organization
  • The Investigation/CAPA challenges affecting organizations and how to address them


  • Site Leaders/Plant Managers
  • Directors of Quality and Manufacturing
  • Manufacturing Supervisors and Managers
  • QA, QC Supervisors and Managers
  • Maintenance Supervisors and Managers
  • Laboratory Managers and Supervisors
  • Quality Assurance/ Quality Control Personnel
  • Document Control Personnel
  • Quality Auditors


William (Bill) Miller a Principal at Black Gold Gray Consulting. With more than 35 years of GMP Manufacturing, Bill has held manager/director positions in Quality Assurance, Manufacturing, Packaging, Purchasing, Distribution and Plant Management.His focus has been turning around organizations 

Most recently as Plant Manager at Ohm Laboratories Gloversville, New York facility –Led a successful FDA Warning Letter remediation.  Reorganized the site for productivity and compliance by hiring and training 90% new staff. Instituted and instilled culture of compliance and accountability, resulting in a site prepared for a smooth return to production. 

Recognized for his mentoring of individuals in supervision and management in the military, Johnson and Johnson, Lederle Labs, Alpharma, Biersdorf and Pfizer. 

Founded Black Gold Gray Consulting to provide hands on guidance to pharmaceutical and over the counter manufacturers with a focus on remediation, compliance, supervision and team building. Comfortable from the production floor to the board room, he is an outstanding communicator and trainer. 

Bill earned a BS in Engineering at the United States Military Academy, West Point, New York.

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