Contact Us Site Map

Our Most Recent Seminar Was:

Risk Based Solutions for FDA Compliance
Including Agile Software Development

April 13-15, 2010
Crowne Plaza Hotel Foster City - San Mateo

-Implementing Global Quality Systems
-Agile and Risk Based Solutions for Design Control Compliance
-Validation of Global IT Software for Regulatory Compliance

SPONSORS

CCS

 

AMDM

 

Bay Bio

 

Perry-D’Amico & Associates

 

 

 

Speakers are from the FDA and leading medical device and pharmaceutical companies. Speakers represent the following organizations:

  • Abbott
  • Applied Biosystems – Life Technologies
  • bioMerieux
  • BioRad
  • Certified Compliance Solutions
  • Ethicon Endo-Surgery
  • Gambro
  • Genentech
  • Genomic Health
  • International Technidyne Corporation – Consultant
  • Life Technologies
  • St. Jude Medical

One day at $595, two days at $1095, or attend all three days for $1395.

Discounted registration is available for government employees and members of AMDM and BayBio.

April 13, 2010 - Implementing Global Quality Systems
April 14, 2010 - Agile and Risk Based Solutions for Design Control Compliance
April 15, 2010 - Validation of Global IT Software for Regulatory Compliance

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

  • How to establish harmonized quality system procedures for a global company
  • Techniques for managing regulatory inspections
  • What FDA looks for during inspections
  • How to use metrics to drive common quality improvements across all company sites
  • How to effectively change corporate cultures
  • What are best practices for MDR and adverse event reporting

Attendees will receive a checklist for managing regulatory inspections.

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

  • Experiences from medical device companies that use Agile development
  • How to implement a risk based design control process based on IEC 62304:2006
  • How to integrate innovation into product design processes
  • How to define quality metrics to tell you when your new products are ready for market launch
  • The most common 483 observations for design control and software validation

Attendees will receive a procedure for risk based software development.

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

  • How to use TIR 36 to define validation practices for non-product software
  • FDA’s compliance observations regarding software validation and Part 11
  • How industry leaders are using ITIL to tailor software validation processes
  • How to validate ERP systems using a risk based strategy
  • Pitfalls to avoid for the rollout of global IT systems
  • Techniques for prevention of software defects

Attendees will receive custom checklists for Part 11 and TIR36 as well as a sample software validation procedure.
     
Your Registration Includes
  • Full day seminars
  • Certificate for Continuing Education
  • Breakfast & lunch daily
  • Networking receptions (Tuesday & Wednesday evenings)
Seminar April 13-15

 
© Certified Compliance Solutions, Inc.
11665 Avena Place, Suite 203 San Diego Ca 92128
858-675-8200 | 858-675-8201 fax