presents an Executive Briefing on how FDA expects Management to establish and oversee your Quality System

This live, high-impact Executive Briefing is available ON-DEMAND and can be delivered in the privacy of your own Boardroom                                                 

Management Responsibility

for Quality Systems:

FDA Expectations for Management Controls, Adequate Resources, Quality Audits and More

Offered when and where you need it...

 

      Understand how and where FDA holds Management responsible for producing safe and effective products

 

      Learn who FDA considers as "Management" and the consequences of Management not fulfilling their roles

 

      Examine procedures and tools to demonstrate compliance, including Management Reviews, Audits, Training and more

 

Get practical, interactive executive-level training

from Martin Browning, ex-FDA investigator and expert advisor to industry leaders worldwide.

 

Management responsibility – to establish and review a quality system, to provide adequate resources, to select and monitor suppliers, and more – is the cornerstone of FDA’s approach to Quality System regulation and compliance with the Food, Drug and Cosmetic Act (FD&C).

 

But what exactly does FDA expect from management? And who’s considered “management” anyway?

 

When FDA visits your facility, how do you prove to the inspector that management is meeting its responsibilities? Get the answers you need from Martin Browning, a 22-year veteran FDA investigator and the co-developer of FDA's Quality System Regulation (The "QSR" -- 21 CFR Part 820) and other rules and policies while serving at FDA Headquarters. Martin is the president and co-founder of EduQuest, a global team of FDA compliance experts, and one the nation's most sought-after advisors to FDA-regulated companies.

 

At the Briefing, your Management Team will learn:

  1. Key FDA laws and regulations underscoring the importance of Management Responsibility

  2. Management's specific roles in a compliant and effective Quality System

  3. What FDA expects you to cover in your Management Reviews, Quality Audits, and Training Programs

  4. Management responsibilities for supplier selection and qualification

  5. Practical guidance for preparing for and managing an FDA inspection

  6. What happens when Management drops the ball -- the consequences of non-compliance

  7. Recommendations for success from an internationally recognized industry trouble-shooter and advisor

Examine The Management Responsibility Briefing curriculum

Review the qualifications & experience of the Briefing Leader

Get more information -- and learn how to schedule the Briefing at your facility

 


 

Briefing Curriculum:

Management Responsibility

for Quality Systems:

FDA Expectations for Management Controls, Adequate Resources, Quality Audits and More

 

Delivered in 2-Hour or 4-Hour Formats, depending on your Management Team's needs and availability

 

What Executives Need to Know about the U.S. Regulatory Framework for Food, Drugs and Devices

The Most Important Quality System Concepts

The Quality System Regulation: FDA's Clearest Statement of Agency Expectations

"Basic" Management Controls: Overview of What FDA Expects

Management Controls: Specific Requirements and Tools to Demonstrate Compliance

Management Controls: Specific Requirements (cont'd) 

FDA's Inspection Methods, including the Quality System Inspection Technique (QSIT)

The Consequences of Non-Compliance

Tips and Recommendations for Success

Questions & Answers/Discussion with Focus on Specific Company Needs and Priorities

 


Why trust your training investment with EduQuest?

 

EduQuest is a global team of FDA compliance experts headquartered near Washington, DC. Celebrating its 20th year of service to FDA regulated industry, EduQuest was founded in 1995 by three former FDA rule-makers and expert field investigators.

 

Since that time -- with hundreds of training classes and consulting assignments worldwide -- EduQuest has helped thousands in the medical device, pharmaceutical, biologics, food and tobacco industries better understand FDA expectations, prepare for FDA inspections, resolve FDA enforcement disputes, and upgrade their Quality Systems to world-class standards.

 

"Unsolicited plug: EduQuest seminars are excellent! If you can attend, you should. I've been to several of your seminars over the years, enjoy them, and always leave with a pile of new information." (Doug Finner, Elbit Systems)

 


 

About Your Briefing Leader:

22 Years of Experience at the FDA; 20+ Years Advising Major Drug and Device Firms Worldwide

Martin Browning,

President of EduQuest

22 years as an FDA investigator, Office of Regulatory Affairs (ORA) senior official, and contributor to the original Part 11 and Quality System rules.

Martin Browning is the President and Co-Founder of EduQuest, a global team of FDA compliance experts based near Washington, D.C. He has more than 30 years of hands-on experience at the FDA and as a highly sought-after advisor to industry.

His 22-year career at FDA included work in the field offices as an investigator and in FDA headquarters as a senior manager in the Office of Regulatory Affairs (ORA). He capped his FDA career by serving as a special assistant to the Associate Commissioner for Regulatory Affairs.

Martin also served as vice chair of FDA’s electronic record and signature working group, where he helped to draft the original 21 CFR Part 11 regulations. In addition, he served as the chair of the U.S. government’s ISO 9000 committee and was a member of the FDA committee that developed the medical device Quality System Regulation (QSR) -- 21 CFR Part 820.

 

At EduQuest, Martin helps clients solve problems related to FDA regulation, quality assurance, management control, software and systems engineering, and compliance auditing, including assessing vendors and outsourced operations. Martin was named Speaker of the Year by the Institute of Validation Technology (IVT) and has received dozens of other awards from the FDA, DIA, ASQ, and other industry organizations.

 

“Martin has a wealth of knowledge when it comes to the FDA and how to answer their questions and address their requests. Many of the experiences he shared were very insightful and something we can take back and share...” (W. Odeh November 2016)

“Martin Browning has a wealth of FDA/industry knowledge, and it is apparent in his examples and conversation he has so much good advice and insights to share. Very credible and yet approachable speaker! Enjoyed his class greatly.” (S. Gillham November 2016)

“Mr. Browning uses his past experience as an FDA inspector to give an accurate insight into the FDA perspective and to cite proper examples from his own experience, which helps to put some of the regulations and expectations into better context.” (Quality Manager, AstraZeneca)

 

“Martin…provided a real sense of what the FDA is looking for today with regard to management of an outsourced supplier. He was easy to follow and very clear in his explanations….” (Account Manager, Neutrogena Corp.)

 

“Mr. Browning’s experience and presentation style were very good. He had great insight into what the FDA expects, and he provided good guidance for companies to move forward on those expectations.” (Senior Facility Auditor, Covance Laboratories)

 

 

Get More Information:

Management Responsibility:

FDA Expectations for Management Controls, Adequate Resources, Audits, and More

 

This on-site, on-demand Executive Briefing is available when and where you need it.

This Briefing can be delivered directly at your facility, when and where convenient for you and your Management Team.

 

Cost is $7,500 per Briefing, plus travel expenses. For up to a maximum of 20 people, Briefing participants receive printed materials with copies of the slides and other presentation materials.

 

The Briefing can be presented in blocks of two-hours or four-hours (recommended), depending on the schedule and availability of your Management Team. Most common schedule is 8:30 a.m. - 12:30 p.m. with one or two 15-minute breaks.

 

Ample time for Questions & Answers/Discussion and personal consultation can be included in the Briefing schedule or immediately afterwards.

 

To check secure a date on Martin Browning's schedule, email Info@EduQuest.net.

Or call +1 (301) 874-6031 between 9 a.m. and 5 p.m. Eastern U.S. Time.

 

Need on-going information and advice from the FDA compliance experts at EduQuest? Subscribe to EduQuest’s free monthly newsletter delivered by email, EduQuest-ions & Answers. Click here to subscribe.

 


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EduQuest: EDUcation: QUality Engineering, Science and Technology    www.EduQuest.net   +1 (301) 874-6031