Current FDA Compliance training courses offered by EduQuest in the months ahead.

 

All courses also available for On-Site, On-Demand training --

when and where convenient for you:

 

EduQuest: A Global Team of FDA Compliance Experts

EduQuest's Fall 2017

Training Class Schedule

 

 

Learn FDA rules from former FDA investigators and rule-makers, including Martin Browning

 

Taught by former FDA field investigators, policy-makers, and senior managers from FDA-regulated industries worldwide. 

 

 

If you're preparing for an FDA or internal audit; need expert advice on FDA's expectations for computerized system validation, or want to comply with Part 11 and the EU's Annex 11, sign-up for:

 

FDA Auditing of Computerized Systems

and Part 11/Annex 11 Compliance:

How to Ensure Data Integrity, Security and Compliance

throughout Your Enterprise

 

EduQuest's most popular, acclaimed course for more than 20 years
 

October 16-18, 2017 - Frederick, Maryland (near Washington, DC)

 

    Sign-Up Here!

 

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If you need to reduce non-conformances, conduct better failure investigations, manage complaints according to FDA rules, or respond to an FDA 483 or Warning Letter about quality problems, sign-up for:

 

The CAPA Compliance Clinic:

FDA Rules for Effective CAPA Systems,

Failure Investigations, and Complaint Management

 

12-hour training class.

Available as an On-Site, On-Demand class.

 

Contact EduQuest to bring this class directly to your site -- when and where convenient for you.

 

 

 

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If you need to develop a by-the-book quality management program for medical device design, production, validation, change control, and inspection preparation, sign-up for:

 

QSR (Quality System) Compliance Basics

(21 CFR 820)

Complying with FDA's Medical Device 21 CFR 820

Quality System Regulation

 

September 18-19, 2017 - Frederick, Maryland

(near Baltimore and Washington, DC)

 

  Sign-Up Here!

 

_____________________________

 

If you need to learn how to comply with FDA's rules for medical device quality design, design transfer, and manufacturing, sign-up for:

 

Design Control for Medical Devices

(21 CFR 820.30)

Meeting FDA's 21 CFR 820.30 Rules for

Quality Design and Manufacturing

 

September 20-21, 2017 - Frederick, Maryland

(near Baltimore and Washington, DC)

 

  Sign-Up Here!

 

_____________________________

 

If you need to better manage the quality performance and conformance of your medical device suppliers, vendors, and contract manufacturers, sign-up for:

 

Managing & Auditing Supplier Quality:

FDA Expectations, Global Standards, and Real-World Solutions

 

12-hour training class.

Available as an On-Site, On-Demand class.

 

Contact EduQuest to bring this class directly to your site -- when and where convenient for you.

 

 

 

____________________________

 

If you need to meet U.S. and international standards for risk management and want to learn to use FDA-recognized tools for risk assessment and mitigation, sign-up for:

 

Quality Risk Management

for FDA, ISO, and ICH Compliance:

Agency Expectations, Global Standards, Tools for Success

 

12-hour training class.

Available as an On-Site, On-Demand class.

 

Contact EduQuest to bring this class directly to your site -- when and where convenient for you.

 

 

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If you need to gain senior management's support of your quality and compliance efforts and alert them of their legal obligations and potential personal and corporate liabilities, contact us about:

 

Management Responsibility for Quality Systems:

FDA Expectations for Management Controls,

Adequate Resources, Quality Audits and More

 

 

Two- or four-hour Executive Briefing presented by Martin Browning.

Available as an On-Site, On-Demand class.

 

Contact EduQuest to bring this class directly to your site -- when and where convenient for you.

 

 

_____________________________

To register for any EduQuest course, click on Sign-Up Form links or call EduQuest:

 +1 (301) 874-6031

Monday through Friday, between 9 a.m. - 5 p.m. Eastern U.S. time.

 


On-Site Training is Available When and Where You Want

 

EduQuest courses can be delivered directly at your facility -- when and where convenient for you and your staff. On-site, on-demand training usually is cost-effective if you have 15 or more who need the training. Contact us by email or phone for details and pricing.

 

To be notified when additional public course dates and locations are confirmed,

Sign up for our monthly Q&A Newsletter here or send us an Email.

 


Most of the classes described above are available in these cost- and time-effective training packages:

The FDA Compliance Bootcamp Course Series

October 16-20, 2017
Hilton Garden Inn Hotel

Frederick, Maryland

 

A 3-day class followed by a 1.5-day class on effective CAPA systems. Attend all 4.5 consecutive days of training for the most effective and efficient use of your time and training investment.

 

Training is designed for pharmaceutical, biologics, and medical device manufacturers, laboratories and clinical research sites, and other industries regulated by FDA, including tobacco and food companies.

 

The FDA Compliance Bootcamp consists of the courses below:

 

Click on course titles for agenda and details:
 

FDA Auditing of
Computerized Systems
and Part 11 / Annex 11:

EduQuest's most popular training class

for more than 20 years

October 16-18, 2017 - Frederick, MD

(Monday through Wednesday)

 

Taught by the same instructors who taught FDA and Health Canada field investigators and managers how to inspect and interpret rules for computerized system validation and 21 CFR Part 11, and the EU's Annex 11.

 

The CAPA Compliance Clinic:
FDA Rules for Effective CAPA Systems,
Failure Investigations, and Complaint Management

The October 2017 dates for this class have been CANCELLED

 

Download & Print Registration Form for the FDA Compliance Bootcamp Course Series.

 

See FDA Compliance Bootcamp Instructor Qualifications

 

The Medical Device Quality & Compliance Institute

September 18-21, 2017

Hilton Garden Inn Hotel

Frederick, Maryland

 

A two-day introductory class on FDA's QSR/device cGMP rules followed by an optional, in-depth two-day class on FDA's rules and expectations for design controls. Attend one or both courses to ensure you understand what FDA will be looking for during your next site inspection.

 

Training is designed for medical device and diagnostic product manufacturers, suppliers and R&D facilities.

 

The Medical Device Quality & Compliance Institute consists of the two courses below.

 

Click on course titles for agenda and details:

 

QSR Compliance Basics:

Complying with FDA's Medical Device 21 CFR 820 Quality System Regulation

September 18-19, 2017 - Frederick, MD

(Monday through Tuesday afternoon)

 

Design Control for Medical Devices:

Meeting FDA's 21 CFR 820.30 Rules for Quality Design and Manufacturing

September 20-21, 2017 - Frederick, MD

(Wednesday through Thursday afternoon)

 

Download & Print Registration Form for the Medical Device Quality & Compliance Institute.

 

See Medical Device Quality & Compliance Instructor Qualifications

 

 

Information current as of September 2017

 

  

 

 

 

 

 

 

Contact EduQuest

 

 

 

 

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