Managing and Reducing Drug and Device GxP Deviations: The Complete Guide to Successful Failure Investigations

GxP deviations ... The moment you discover one, doubts set in. What's your next step? Who must be notified, and how? Will a failure investigation really uncover the root of the problem? And that CAPA — how do you know it's the right one?

Now FDAnews and MHP Consultants are offering an interactive workshop that answers all these questions and much more ... AND gives you the tools you need for full compliance with FDA and international regulations on managing and reducing GxP deviations — over the entire investigation life cycle.

Click here to view the agenda!


Click here to view the entire brochure!

Register Now!

At Managing and Reducing Drug and Device GxP Deviations workshop, you will discover how to:

  • Spot deviations quickly and accurately (exclusive data checklist!)
  • Interview your employees and question corporate processes with field-tested tips that really work
  • End "feel good" investigations: Apply expert techniques to expose root causes
  • Choose the right investigator to lead your strategy meetings (so you never fall prey to this common investigation pitfall)
  • Keep your strategy meetings productive using proven tricks of the trade
  • Analyze — and challenge — CAPAs to choose the best action every time
  • Decide what you should (and shouldn't) include in your investigation report
  • Craft and present a comprehensive "investigation package" that both employees and executives will use

From enterprise-level companies to the smallest start-up, no firm is safe from GxP deviation warning letters, including yours. Protect your investigation from start to finish: Register for this attendee-focused workshop today!

Exclusive Attendee-Focused Workshop

Unlike the one-size-fits-all workshops that you may have attended, Managing and Reducing GxP Deviations is built around you.

Here's how it works. Fill out the exclusive pre-workshop survey (you'll receive it once you register) for two days of:

  • Hand-picked investigation case studies best suited to your situation
  • Targeted breakout sessions geared toward your GxP skill set
  • Instant rapport with expert presenter Michele Piepoli — she'll have reviewed your "GxP trouble spots" before you meet!
  • And much more

Bottom line? For targeted material ... top value ... and true networking, sign up for Managing and Reducing GxP Deviations — the workshop that's focused on you.

Your valuable course materials book is packed with tools and reference data you can put to use right away, including:

  • Slides from PowerPoint presentations
  • Case review worksheets
  • Interactive exercise worksheets
  • Checklist of key elements in preliminary investigation
  • Checklist for data gathering
  • Investigation report template
  • Notification of a deviation template
  • Reference documents:
    • FDA guideline for handling of out-of-specification test results
    • CFR 210-–211
    • CFR 820
    • ISO 13485
This intensive hands-on training workshop is a must for anyone involved in contract laboratories as well as positions in drug, device, biologics, diagnostics including:

  • Auditors
  • QA/QC managers and directors
  • Compliance officers
  • R&D management
  • Laboratory management
  • Risk management specialists
  • Regulatory and legislative professionals
  • Engineering and design control teams
  • Manufacturing directors and supervisors
  • Validation specialists, scientists and engineers

Michele Piepoli, president of MHP Consultants, has more than 35 years of experience in the industry. During the past eight years, Michele has been actively involved in implementation of quality systems within the pharma industry. Michele has led quality projects in the domestic and international community.

She previously served as director of Shuster Laboratories' Pharmaceutical Division, where she was responsible for fiscal and technical operations as well as assuring full regulatory compliance of the facility. Her laboratory expertise includes chromatography, spectroscopy, method development/validation and instrumentation validation.

Michele has extensive experience in developing and presenting compliance training seminars, conducting facility audits and playing a key role in the development and implementation of quality systems.

Date and Location
Oct. 8–9, 2009 • Raleigh, NC
Marriott Raleigh Crabtree Valley
4500 Marriott Drive
Raleigh, NC 27612
+1 (919) 781-7000
Toll free: (800) 228-9290
Room rate: $149.00 single or double (plus 12.75 percent tax)
Hotel reservation cutoff date: 9/16/09


Register Early — Space is Limited
Hurry — register early because space is limited! Your tuition of $1,897 per attendee includes the two-day workshop, all conference materials, continental breakfast and lunch each day. Payment is required by the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to FDAnews.

Send Your Team for Maximum Benefit
Get your team up to speed in just three days!

Significant tuition discounts are available for teams of three or
more from the same company. You must register at the same time and provide a single payment to take advantage of the discount.

Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
to learn about our special tutiton discount.

Team Discounts
Significant tuition discounts are available for teams of three or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount. Call +1 (703) 538-7600 for details.

Written cancellations received at least 21 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee.  No cancellations will be accepted — nor refunds issued — within 21 calendar days from the start date of the event.  A credit for the amount paid may be transferred to any future FDAnews event.  Substitutions may be made at any time. No-shows will be charged the full amount.  In the event that FDAnews cancels the event, FDAnews is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Exhibit and Sponsorship Opportunities
For exhibit and sponsorship opportunities at this event, please contact:
Andrew McSherry
Phone: +1 (703) 538-7643 • Fax: +1 (703) 538-5000

Interested in becoming a speaker?
We're always looking for industry leaders eager to share their expertise at an FDAnews physical conference, webinar or audioconference. Our seasoned speaker community includes executives in the pharmaceutical, medical device and clinical trial industries, regulatory affairs, quality control, compliance, healthcare and academia, as well as several former — and current — top FDA officials. Click here to complete our speaker opportunity form and have a representative contact you about future opportunities.