Validation Seminars in DC

PRESS RELEASE
Phone: 703-525-4159
Email: nancy@compliance-alliance.com
Website: www.compliance-alliance.com

WASHINGTON DC, USA -- PHARMA UPDATE NEWS SERVICE(TM) -- JULY 25, 2006: FOI Services, The Gray and Silver Sheets, and NEMA are co-sponsoring three important seminars presented by Compliance-Alliance in Washington on:

  1. Design Control and Software Validation Practices - Sept. 11
  2. System Validation and 21 CFR Part 11 - Sept. 12
  3. ISO 14971 and Safety Risk Management - Sept. 13

The faculty either helped write the rules or created industry best practices.

  • Larry Kessler, Sc.D, Director, CDRH's Office of Science and Engineering
  • Al Taylor, CDRH's Office Science and Engineering
  • George Smith, FDA - Member of Committee on 21 CFR Part 11
  • Dan Olivier, Certified Software Solutions (FDA expert witness)
  • Ron Gerner, Manager, Abbott Laboratories
  • Lindsey Howard, Digene Corporation
  • Tracey Holevas, GE Healthcare
  • Robert Kanaley, Guidant Corporation
  • Harvey Rudolph, Underwriters Laboratories
  • Nancy Singer, Compliance-Alliance (formerly with AdvaMed)
  • Marlene Bobka, FOI Services

Details on each seminar are below. Register for one day at $795 (US), two days (Monday - Tuesday or Tuesday - Wednesday) at $1490 (US). Attend all three days for $2185 (US). Discounts are available for registering 3 or more people for more than one seminar.

For more information go to www.compliance-alliance.com.

SEMINAR 1: Design Control and Software Validation Practices - Sept. 11

During this seminar you'll learn from FDA and industry leaders:

  • The most common 483 observations for design control and software validation
  • The "real" definition of validation and verification
  • Ways to defend the adequacy of your process and prevent document creep
  • Tactics to defend your test completeness process
  • Keys to drafting useful requirements specifications
  • Ways to define procedures that will minimize 483 observations

You'll also get guidelines and checklists for code, design description, requirements specification and test review.

For a complete agenda and testimonials, go to www.compliance-alliance.com/design_control_dc.htm

SEMINAR 2: FDA Requirements for System Validation and 21 CFR Part 11 - Sept. 12

During this seminar you'll learn from FDA and industry leaders:

  • The new Part 11 proposed regulation
  • FDA's plans for implementation
  • FDA's expectations for cybersecurity
  • When you have to revalidate your quality system software
  • What systems require Part 11 compliance
  • How to address related regulatory requirements (SOX, HIPAA, and ISO 13485)

You'll also get custom procedures, specifications and checklists for IT security, Part 11 software requirement specs, and software development.

For a complete agenda and testimonials, go to www.compliance-alliance.com/Part11DC.htm

SEMINAR 3: ISO 14971 and Safety Risk Management - Sept. 13

During this seminar you'll learn from FDA and industry leaders:

  • What to include in your risk analyses, risk evaluation, risk control and post production information
  • How to use risk management in evaluating complaints, CAPAs, CARs & supplier audits
  • Ways to streamline your risk analysis activities
  • Risk management techniques such as FEMA, FTA, HACCP and HAZOP
  • How to use risk management to improve your design

You'll also get a risk analysis checklist with 130 questions that should be asked in every risk analysis process.

For a complete agenda and testimonials, go to www.compliance-alliance.com/ISO14971DC.htm

FOR MORE INFORMATION:

For questions, contact Nancy Singer at 703-525-4159 or nancy@compliance-alliance.com
    1401 North Oak Street, Suite 604
    Arlington, VA 22209