Get On-Site Training from EduQuest’s FDA Experts: Classes When & Where You Need Them

Save time and money by bringing EduQuest’s acclaimed instructors and interactive training classes directly to your facility.

With our On-Site, On-Demand Training Services, EduQuest can bring its courses literally to your doorstep. You’ll save airfare, hotel and other travel costs for all your students and — even more importantly — minimize the time your staff members are away from their daily responsibilities.

EduQuest’s on-site training services include pre-training consultation on your specific needs and concerns, course customization (if necessary), instructor travel arrangements and expenses, printed course materials for each participant, and Certificates of Attendance to document the training for your employee files and inspection records.

Is On-Site Training Right for You?

As a general rule, you should have at least 15 or more students to make on-site training cost-effective. Fewer than that, it may be better for your company to send the students to one of our public class offerings.

We also strongly recommend limiting each class to no more than 35 students. That way, we can offer the best student-instructor interaction and allow ample time for student questions. If you have more than 35 students who need the training, we will schedule multiple classes to meet their needs and your schedule.

Benefits of On-Site Training from EduQuest:

  1. Training when you need it…where you need it
  2. World-class training provided by the same instructors who have trained the U.S. FDA and Health Canada inspectors and managers
  3. Hands-on, interactive and — above all — practical learning targeted to your needs
  4. Perfect for maximizing limited training and travel budgets
  5. Nearly 20 years of providing effective training for major pharmaceutical, medical device, biologics, tobacco, and food companies throughout the world
  6. Off-the-shelf as well as customized courses available

EduQuest’s Off-the-Shelf (but continually updated) Courses Include:

Computer Systems and Process Validation

  • FDA Auditing of Computerized Systems and Part 11/Annex 11
  • Process Validation for Medical Devices

Risk Management

  • Quality Risk Management for FDA/ICH Q9 Compliance
  • Process Risk Management Explained

Quality Systems

  • Effective CAPA Systems, Failure Investigations, and Complaint Management
  • QSR Compliance Basics
  • Design Control and Design Transfer for Medical Devices
  • Quality Systems for Drugs & Biologics
  • FDA Regulations for Sales, Service and Distribution

Supplier Management

  • Managing Supply Chain Risks
  • Supplier Auditing for QSR Compliance

Inspection Preparation

  • Preparing for and Managing FDA Inspections
  • Responding to 483s and Warning Letters

Course length varies from one to three days and can be tailored to your schedule.

High-Level Executive Briefings Available:

Executive Briefings — ranging from one to four hours — are available on all topics.

One of the most popular Executive Briefings we deliver is:

  • FDA Expectations for Management Control

EduQuest On-Site Training Overcomes Distance, Multi-Facility Barriers:

On-site courses can be delivered anywhere in the world. Just in the past year, EduQuest has delivered training in the U.K., Germany, Switzerland, India, and Israel.

If your staff is scattered geographically, training webinars and audio-conferences also are available.

Recent training assignments have included:

  • A series of four “deep dive” training classes on FDA’s expectations for Design Control and Transfer for a global medical device manufacturer
  • 4-hour Executive Briefing on Management Responsibility for Quality Systems for the divisional heads of a multi-national FDA-regulated company
  • 4-hour Q&A training session on Computer Validation and Electronic Records Management for managers at a Fortune 500 healthcare company
  • 4-day, hands-on training of corporate auditors, teaching them How to Audit Supplier Quality Systems
  • 16-hour Change Control training class focusing on Equipment Qualification and Process Validation for a major materials testing lab
  • 12-hour QSR Compliance Essentials training for new hires at a scientific instrument manufacturer
  • 90-minute webinar on FDA Rules for Pre-Market Audits for an audience of nearly 200 product managers and auditors on three continents

Combine Your Training with a Mock FDA Audit:

In addition, EduQuest instructors, many of whom are ex-FDA investigators and rule-makers, often are asked to perform combined Auditing/Consulting and Training assignments.

For example, in one cost-effective visit, EduQuest can provide a Mock FDA Audit of your facility, followed by the appropriate level of training focused on any gaps or deficiencies we identify during the audit.

Make EduQuest a Partner for Upgrading Your FDA Compliance Know-How:

>>Email Martin at EduQuest about your training needs and request an On-Site Training Quote.

Please include your desired training topic, a description of the audience for the training (an overview of their responsibilities, backgrounds, and experience levels), the number of students who need to be trained, and your preferred location and timing for the training. We will follow-up with you to further pinpoint your training needs and prepare a cost proposal within 48 hours.

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