Overview: The verification and validation of medical software is coming under increased scrutiny by the U.S. FDA.
This webinar will address the use of the FDA, GAMP, 21 CFR Part 11, "Electronic Records" / "Electronic Signatures", and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Product Risk Management models, to structure, run, and document acceptable software validations. The FDA and other regulatory agencies have stated that software validation can realistically only be accomplished effectively if "risk-based". How can this be accomplished in the "real world". This webinar will address software that is:
* As-Product
* In-Product
* In Production and Test Equipment and
* The Quality System
A manufacturer is responsible to identify these requirements and implement them into an effective software V&V process.
Why Should You Attend: Software has become pervasive in medical devices themselves, and in the controlling, running and monitoring of medical product processes, whether they be in the pharmaceutical, medical device, biologics or dietary supplements industries. Software is being developed for medical imaging, and even though control of computer for individuals having disabilities restricting hand or eye movement / coordination. The U.S. FDA rightly recognizes that virtually all software quality problems occur in the design, testing and validation phases, since replication of software is relatively defect-free. Regulatory auditors are more comfortable with delving into software issues. Recent problems in unrelated industries show the dangers of neglecting thorough, and risk based software verification and validation activities. Effective and real world software V&V is even more important in today's resource constrained industrial environment.
Areas Covered In the Session:
* Verification or Validation
* Current Regulatory Expectations and Recent Audit "Hot Buttons"
* The Project Validation Plan
* Product and Process / / Facilities / Equipment Software V&V
* When and How to Use DQ, IQ, OQ, PQ (or their equivalents)
* GAMP / Other Considerations
* The FDA's 11 Key V&V Documentation Elements
* "White Box" and "Black Box" Validations
Who will benefit:
* Senior management in Drugs, Devices, Biologics, Dietary Supplements
* QA
* RA
* R&D
* Engineering
* Production
* Operations
* Consultants; others tasked with product, process, electronic records software V&V responsibilities
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
This webinar will address the use of the FDA, GAMP, 21 CFR Part 11, "Electronic Records" / "Electronic Signatures", and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Product Risk Management models, to structure, run, and document acceptable software validations. The FDA and other regulatory agencies have stated that software validation can realistically only be accomplished effectively if "risk-based". How can this be accomplished in the "real world". This webinar will address software that is:
* As-Product
* In-Product
* In Production and Test Equipment and
* The Quality System
A manufacturer is responsible to identify these requirements and implement them into an effective software V&V process.
Why Should You Attend: Software has become pervasive in medical devices themselves, and in the controlling, running and monitoring of medical product processes, whether they be in the pharmaceutical, medical device, biologics or dietary supplements industries. Software is being developed for medical imaging, and even though control of computer for individuals having disabilities restricting hand or eye movement / coordination. The U.S. FDA rightly recognizes that virtually all software quality problems occur in the design, testing and validation phases, since replication of software is relatively defect-free. Regulatory auditors are more comfortable with delving into software issues. Recent problems in unrelated industries show the dangers of neglecting thorough, and risk based software verification and validation activities. Effective and real world software V&V is even more important in today's resource constrained industrial environment.
Areas Covered In the Session:
* Verification or Validation
* Current Regulatory Expectations and Recent Audit "Hot Buttons"
* The Project Validation Plan
* Product and Process / / Facilities / Equipment Software V&V
* When and How to Use DQ, IQ, OQ, PQ (or their equivalents)
* GAMP / Other Considerations
* The FDA's 11 Key V&V Documentation Elements
* "White Box" and "Black Box" Validations
Who will benefit:
* Senior management in Drugs, Devices, Biologics, Dietary Supplements
* QA
* RA
* R&D
* Engineering
* Production
* Operations
* Consultants; others tasked with product, process, electronic records software V&V responsibilities
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
