Course Description:

Every company regulated by the U.S. FDA establishes procedures, practices and an internal monitoring system all designed to both meet the regulations and manage inspections. However, many are surprised by Warning letters or more serious actions. Regardless of whether your company has been on the receiving side of a regulatory action or not, this course will help you in have better Quality systems, effectively managing and responding to FDA inspections.

The first day will provide you with a better understanding of the FDA culture and the unique focus of FDA investigators during inspections. You will learn what are the observations and events that will signal to you that serious regulatory actions may follow. With prior knowledge, you can identify potentially serious deficiencies before an inspection in addition to responding quicker whenever serious issues are identified.

The key to being “inspection ready” are effective written procedures, training programs and monitoring including internal auditing. The instructor having more than 40 years of experience with FDA and the pharmaceutical industry will on the second day share his perspectives on what can be improved in these systems. If you believe that any Quality system can be improved or at least that it is important to constantly re-evaluate whether your own systems, you will benefit from attending.

Those benefiting include both those from the pharmaceutical and medical device industries. Events and observations from both industries will be used.

Seminar instructor David Haggard has more than 30 years’ experience with the U.S. FDA. He started with the FDA as an investigator and advanced to supervisory investigator, director of the San Juan Puerto Rico Investigations branch, direction of FDA ORA’s inspection branch and finally as the director of the Office of Enforcement’ division of compliance policy.

Learning Objectives:

  • Understanding FDA's enforcement strategy and what it means to your firm
  • Understanding how auditors think and their expectations
  • Being prepared to receive regulatory inspections
  • Recognizing when inspectional findings or events indicate potential regulatory actions
  • When to take or not immediate action during an inspection
  • Making better responses to FDA both during and following inspections
  • How to make written procedures and training more effective
  • How to increase the effectiveness and efficiency of internal audits
  • How to identify effective compliance metrics

Who should Attend:

  • Managers responsible for GMP compliance and seeking a better understanding of FDA, inspections, regulatory actions and how they can improve their own firm's operations and monitoring of their state of GMP compliance
  • Individuals who come in contact with regulatory inspectors
  • Auditors
  • Compliance/Regulatory affairs professionals
  • QA/QC professionals
  • Senior management executives (CEO, COO, CFO, etc.)
  • Manufacturing managers, supervisors & personnel
  • Project Managers
  • Consultants

Course Outline:

FIRST DAY: 8:30 AM - 6:00 PM
8:30 am – 9:00 am Registration Process
9:00 am Session Start
9:00 – 10:30 am Understanding FDA’s culture, enforcement strategies and options
10:30 – 10:45 am Break
10:45 – 12:00 noon FDA’s risk-based focus and how it drives an inspection
12:00 noon – 1:00 pm Managing an inspection; the do’s and don’ts
1:00 pm – 2:00 pm Lunch
2:00 – 3:00 pm Awareness of violations and GMP deficiencies that drive injunctions
3:00 – 3:45 pm Recognizing signs during the inspection of pending actions
3:45 – 4:00 pm Break
4:00 – 5:30 pm How to respond to FDA during and following the inspection
5:30 – 6:00 pm Questions
SECOND DAY: 8:30 AM - 12:30 PM
8:30 – 9:30 am Why procedures /training are inadequate and how to fix it
9:30 – 10:00 am Compliance metrics: distinguishing between productive / counterproductive
10:00 – 10:15 am Break
10:15 – 11:30 am Internal Audit Programs: How to make them more effective and efficient
11:30 – 12 noon Compliance monitoring; why you should go beyond auditing
12 noon – 12:30 pm Questions /Answers
12:30 pm Adjournment

Meet Your Instructor

David Haggard
GMP Regulatory Consultant, David Haggard Associates LLC

David Haggard: Currently leads a consulting practice offering auditing, training and advising to small, medium and large pharmaceutical firms as a follow-up to a 30+ years’ experience with the U.S. FDA and 10+ years with Merck & Co., Inc. His experience with the FDA started as an investigator and advanced to supervisory investigator, director of the San Juan Puerto Rico Investigations branch, direction of FDA ORA’s inspection branch and finally as the director of the Office of Enforcement’ division of compliance policy. With Merck & Co., Inc., he initially served as the director of the worldwide GMP policy & compliance group and retired as the senior director of an auditing group responsible for both oversight GMP and automation audits of Merck sites as well as audits of all external joint ventures, licensees, contracted manufacturing and testing facilities along with all external suppliers supporting commercial supply. At FDA and Merck he received a number of awards / recognition for innovative customer-focus approaches that increased effectiveness and efficiencies.

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What past attendees say:

The presentations were very thorough and gave insight into the culture and thought process of an FDA investigator. Gave useful advice that can be implemented to making improvements - hopefully lasting improvements.
- Acute Pharmacy Services Manager, Intermountain Healthcare Supply Chain Pharmacy

Presenter was knowledgeable. He did a good job staying on task.
- General Manager/Partner, Micro Filtrations Inc.

“Managing the Inspection" Topic helped me to understand what the Investigator thinks.
- Director, Quality Assurance, Abbott Vascular

I liked the personalized training and presentation with example. Especially 2nd Day presentation helpful to my job.
- Senior Regional Site Manager, Forest Research Institute

Quick response, keeping you updated, have great programs.
- Senior Regional Site Manager, Forest Research Institute

I liked the entire course, which provided entire overview.
- QA Senior Specialist, Bayer HealthCare LLC

I had registered for a seminar but unfortunately I was not able to attend. The company was very understanding and extremely helpful. I plan on attending a future event soon.
- Director of Regulatory Affairs, Nickell Physician & Pharmacy Services

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