FDA Compliance Boot Camp 2012 Validation, Quality and Compliance Training

$2,795.00
Quantity Discounts
1 - 9999
$2,795.00
1 - 9999
$1,495.00
1 - 9999
$1,495.00
1 - 9999
$3,795.00
1 - 9999
$3,795.00
 
 


Imagine getting inside the head of a working FDA inspector ... receiving the same training the inspector gets ... knowing which problems face the most scrutiny ... all before your next inspection.

Here's how.

Are you confident you'll sail through your next inspection? You can be when you have the same training the FDA gives its own inspectors.

Know what to expect when the next inspector walks through your door -- from what the agency trains its investigators to look for ... to which problems face the most scrutiny, including how FDA expects you to manage your computerized systems and electronic records.

You'll even discover which of your systems will be first-up for inspection. And you'll learn what's behind FDA's new add-on "surveillance inspections" for Part 11 and how the European Union's new Annex 11 affects your operations, no matter where they are.

Former FDA Investigators Ready to Give You "Insider Advice"

Why risk a single noncompliance penalty? When you attend FDA Compliance Boot Camp 2012 you can feel secure in knowing your next inspection will be a complete success ... And it takes less than a week.

Experience a simulated inspection, pick up effective self-auditing techniques and so much more.

Comments from Previous Boot Camp Attendees

"One of the best training [courses] I ever attended."

"Excellent, knowledgeable, interesting instructors."  

 "Great to go over what FDA looks for. Everything was relevant!"

Save $495 Now: When You Choose a Multiple Course Track

Choose any one course or a combination of courses (see the schedule below) to suit your needs and fit your schedule. Following is a list of the courses and learning objectives of each.

Course #1 — FDA Auditing of Computerized Systems and Part 11/Annex 11 (24 Course Hours) The FDA is facing a looming crisis of public confidence in two areas directly impacted by computer systems validation — data integrity, especially in clinical and manufacturing environments, and supplier quality assurance.

Enroll your team in the FDA Compliance Boot Camp to ensure your company and its contractors and suppliers aren't in the cross hairs of the FDA's stepped-up enforcement in these areas.

You'll learn:

  • Which computer systems need to be Part 11 compliant
  • When system validation is required
  • What compliance gaps FDA is finding from its "tag-along" Part 11 audits
  • Can you validate "cloud" systems or vendor-hosted networks?
  • What in the world are "predicate rules" and why you must know them
  • Why lots of compliance dollars and resources are wasted on ineffective or inadequate validation
  • How to identify, document and report computerized system validation deviations
  • Top validation errors cited in FDA enforcement actions
  • Proactive steps to avoid CSV and Part 11 Form 483s and warning letters
  • Proven techniques for developing compliant software
  • Key principles of computerized system validation
  • Change control and configuration management
  • Ways to work with audit trails and protect data access and transfer
  • Evaluation of software vendor compliance claims
  • How to prepare for the FDA inspector using a simulated inspection with real-world scenarios
  • Five critical pillars required for effective CSV
  • Current status of Part 11 — revisions, rewrite or abandonment?
  • How Part 11 compares with the EU's new Annex 11
  • Why data integrity is critical with or without Part 11
  • Keys to maintaining your systems in a validated state

Course #2 — Quality Risk Management for FDA/ICH09 Compliance: Agency Expectations, Global Standards and Tools for Success (12 Course Hours)

Risk management is the bedrock of FDA regulation in the 21st Century.

But ask 10 companies how they define risk, and you're likely get 10 different answers. How can you and your team master something as elusive but vital as risk management? Begin by attending this 12-hour training class and learn FDA's approach to assessing and managing risk. You'll also study tools and methodologies used by regulated companies around the world.

Companies that ignore the heightened public and legal demand for cradle-to-grave product risk management imperil their shareholders and their public reputation.

Enroll your team in Quality Risk Management for FDA/ICH09 Compliance to train your key staff on the biggest compliance pitfalls facing companies today.

You'll learn:

  • The FDA's expectations for managing people, product and process risks
  • The language of risk: concepts and definitions of risk management as used by the FDA
  • How to better integrate risk management with your quality system
  • Regulatory foundations for risk management
  • The role risk management plays in developing compliant GxP and electronic record-keeping systems
  • How to use risk-based decision-making to justify your validation and production decisions
  • Proven tools for risk assessment
  • The inter-relationship of ISO 14971, ICH Q9, and FDA's GxP rules
  • What's ahead — and why you must develop a mindset to always evaluate risk

Course #3 — The CAPA Confidence Clinic: FDA Rules for CAPA Systems and Failure Investigations (12 Course Hours)

If your current CAPA system is disorganized, poorly documented, or not supported by thorough failure investigations, you're waving a red-flag to FDA inspectors and third-party auditors. Get your quality program back on track by building a robust CAPA system that meets FDA's latest expectations.

The popular The CAPA Confidence Clinic: FDA Rules for CAPA Systems and Failure Investigations 1 ½-day course offers instruction on the identification of corrections, corrective actions and preventive actions along with terms that are used to describe nonconformities and CAPA data sources.

Learn how an effective CAPA system can reduce your manufacturing costs, minimize product recalls, and ensure product safety and effectiveness. Discover the elements of a compliant CAPA system, how to get to the root cause of a system failure, and more. You'll learn:

  • The FDA's requirements for CAPA systems
  • Why CAPA systems continue to be at the top of the FDA's enforcement list
  • Definitions of a correction, corrective action and preventive action — and why the difference matters
  • 32 important and often overlooked sources of CAPA data
  • Recommended flow charts for CAPA data collection and closure
  • Key elements of compliant CAPA systems
  • Picking the right CAPA tracking tools
  • How to conduct a proper failure investigation to its root cause
  • FDA's trending rules -- and how Quality Data Trending helps you better manage product risk
  • Lessons learned from recent FDA 483s and warning letters

In addition, throughout the courses offered in the Boot Camp, you'll discover ...

  • What it's like to undergo an actual FDA inspection. Compliance Boot Camp's simulated inspection exercise is as close to the real thing as you're likely to get — until the day the investigators actually visit your facility
  • What FDA investigators are trained to look for ... which systems they inspect first ... which problems get the most scrutiny
  • Self-auditing techniques to use before the investigators call
Receive the ValidationVault™ Resource CD
Free with your Boot Camp attendance

A $295 value, the Resource CD gives you desktop access to a treasure-trove of FDA laws, regulations and guidances, inspection protocols, warning letters, and international guidelines.

The CD has been designed by the Boot Camp instructors specifically for those involved in computerized systems validation, quality management, software development, or electronic records/signatures compliance. Included in the ValidationVault™ Resource CD are the latest versions of the FDA's Investigations Operation Manual, relevant Title 21 CFR regulations, a complete library of FDA guidance documents related to validation and Part 11, key ICH guidelines and much more.

Register today and reserve your free copy of the ValidationVault™ Resource CD.

Deploy an arsenal of compliance knowledge
and rank at the top for your next FDA visit!

FDA Compliance Boot Camp 2011 includes three courses — one based on the same computerized system validation and Part 11 training the FDA gives its own investigators, one on CAPA systems and one on risk management.

Get five days of hands-on, interactive training.
Course instructors have trained the FDA's own investigators
— and some are former FDA investigators themselves.

Martin Browning is your course leader. A former FDA top official, Martin helped draft the original Part 11 regulations. He and his team have trained hundreds of key FDA and industry personnel. Now that same training is available to you and your staff.

Mr. Browning, president and cofounder of EduQuest, 2004 IVT Speaker of the Year, capped a 22-year FDA career as a special assistant to the associate commissioner for regulatory affairs. As vice chair of the electronic record and signature working group, he helped draft the original 21 CFR Part 11 regulations. He also served as the chair of the U.S. Government's ISO 9000 committee, and was a member of the committee that developed the medical device quality system regulation.

Other members of the EduQuest training team include computer and compliance experts with extensive FDA experience plus decades more experience in engineering, software, quality, validation and manufacturing positions with leading FDA-regulated companies.

"The instructors are obviously very experienced and
they make this whole conference fun and informative.
It was one of the best classes I have ever attended."
— Previous Boot Camp Attendee


Register today if your responsibilities include:

• Quality assurance/quality control • Research and development
• Validation • Information technology/transfer
• Electronic records • Software development
• Regulatory affairs • Internal auditing
• Document management • Vendor management
• Laboratory information management systems • Software and computerized systems procurement
• Clinical trial data  

March 26-30, 2012
Hilton Garden Inn Frederick
7226 Corporate Court
Frederick, MD 21703
www.frederick.stayhgi.com
Reservations: 866-909-6090
Room rate: $109 per night, plus tax
Reservation cut-off date: March 5, 2012

 

Select From Three Courses:

 
Course #1: FDA Auditing of Computerized Systems and Part 11/Annex 11
(24 Course Hours)
Course #2: Quality Risk Management for FDA/ICH09 Compliance
(12 Course Hours)
Course #3: The CAPA Confidence Clinic: FDA Rules for CAPA Systems and Failure Investigations
(12 Course Hours)
Fee
$2,795
$1,495
$1,495
Mon.

8:30 a.m. –
5:30 p.m.

   
Tues.
8:30 a.m. –
5:30 p.m.
 
 
Wed.
8:30 a.m. –
5:30 p.m.
 
 
Thurs.  
8:30 a.m. –
5:30 p.m.
8:30 a.m. –
5:30 p.m.
Fri.  
8:30 a.m. –
12:30 p.m.
8:30 a.m. –
12:30 p.m.

Select a Multiple Course Track and Save $495
Combination
Discounted Fee
Track A:
Courses 1 & 2
$3,795
Track B:
Courses 1 & 3
$3,795

 

 

 

 

 


Save When You Register for Multiple Courses!

Register now for a combination of Compliance Boot Camp's training courses. Sign up for multiple courses and save. See the schedule.

Send Your Compliance Team for Minimal Cost and Maximum Benefit!

Get your compliance team up to speed in just one week and save.

Significant Tuition Discounts — Register 4 members for the same course and send the 5th member for FREE.  You must register at the same time and provide a single payment to take advantage of the discount. 

Call +1 (703) 538-7600 or toll free (888) 838-5578 to make your team reservation.

Payment is required by the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to FDAnews.

Or, register by phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600.

Cancellations and Substitutions
Cancellations received before the beginning of a course will be subject to a refund according to the following schedule and rates: A 95% refund will be provided for cancellations received up to 6:00 PM EST, 10 business days in advance of the course start date. If less than 10 business days advance notice is provided, the refund amount will be reduced to 50%. Substitutions are permitted with prior notification to FDAnews. Individuals requesting to change course location less than 10 business days in advance of the course will be charged a $500 administrative fee. No-shows will be charged the full amount. FDAnews reserves the right to cancel the courses and is not responsible for any airfare, hotel, or other costs incurred by registrants.

We look forward to having you join us.
    

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