Validation-Product, Process or Equipment and QMS Software
Training
Online
*Indicative price
Original amount in USD:
$ 150
Description
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Type
Training
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Level
Advanced
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Methodology
Online
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Class hours
3h
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Duration
1 Day
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Start date
October
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Virtual classes
Yes
The FDA and other regulatory agencies have stated that software validation can only be accomplished effectively if "risk-based". How can this be done in the "real-world".
Facilities
Location
Start date
Start date
Reviews
Subjects
- Risk
- Medical
- Medical training
- IT risk
- Compliance Trainings
- Healthcare
- Medical courses
- Online Trainings
- Compliance education
- Industrial courses
Teachers and trainers (1)
Adam Fleming
Event Manager
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. . Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements.
Course programme
The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records"/"Electronic Signatures", IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations.
The FDA and other regulatory agencies have stated that software validation can only be accomplished effectively if "risk-based". How can this be done in the "real-world".
This webinar will address software that is:
- As-Product
- In-Product
- Process and/or In Production and Test Equipment and
- The Quality System/CGMPs
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. A quick review of Internet forums will show much confusion about the subject. Software is being developed for medical imaging, and even thought control of computers. It is increasingly being used for e-records and e-signatures.
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. Effective and real world software V&V is even more important in today's resource constrained industrial environment. This discussion will focus on a preferred U.S. FDA documentation "model" in various applications, including ERP, in-device, as-device, process/equipment control, and cGMP data / 21 CFR Part 11 (and EU Annex 11) applications.
Areas Covered in the Session:
- Verification or Validation-FDA Expectations
- The Project V&V Plan
- An FDA-accepted Documentation "Model"
- Product and Process/Test Facilities/Equipment Software V&V
- When and How to Use DQ, IQ, OQ, PQ (or their equivalents)
- The FDA's 11 Key V&V Documentation Elements
- "White Box" and "Black Box" Validations
- IEC 62304, GAMP/Other Considerations
Who Will Benefit:
- Senior Management in Drugs,Devices,Combination Products,Biologics,Dietary Supplements
- QA / RA
- Software development,Programming,Documentation,Testing teams
- R&D
- Engineering
- Production
- Operations
Additional information
Validation-Product, Process or Equipment and QMS Software
*Indicative price
Original amount in USD:
$ 150