Cost Effective and Convenient - in your office or conference room
Practical and Effective Application
of Design Review:
An FDA Requirement for New or Modified Facilities or Systems
Conducted by Miguel Montalvo
President - Expert Validation Consulting Inc.
July 17, 2009
This web seminar will address the design review expectations for new facilities/systems or major modifications as a new concept being applied in the drug manufacturing industry. The FDA is enforcing this step as part of a Quality System and Quality By Design approach through the application of the new guideline on Quality Systems and the ICH Quality guidelines such as the Q7A and the Q10.
This is a concept that makes good business sense – review the design to meet your specifications before you start the construction/building stage. However, in order to be effective and practical in our implementation of this procedure, a risk-based approach must be applied including the decisions in terms of which systems and at what level to apply the Design Review requirements.
By effectively applying this procedure, the project will have a greater possibility of success and the cost for implementation should be reduced by involving all pertinent functions as early as possible and addressing any revisions/changes at the earlier stages. The Quality function, which in the past was not involved to an adequate level in the design of facilities, equipment and systems, will be part of the team to perform the review in addition to the system/facility/equipment user.
This seminar will include instructions on how to:
- Define the requirements to complete a Design Review of a major project
- Develop a Design Review policy/procedure and the applicable forms/documentation
- Determine the responsibilities of each functional group and their level of involvement during the Design Review process
- Apply different levels of Design Review based on the System Impact and Risk-based Analysis
At the completion of this seminar the participant will be able to:
- Develop a practical yet effective Deisgn Review procedure and define the documentation requirements
- Perform a Design Review and adequately document the results
- Understand the reasons behind conducting a Design Review - Quality and Business perspective
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All registrations include handout materials. Once you’re registered, you will receive via e-mail (the e-mail address you provide in your registration) the web location to download the handout materials.
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|Get the MP3 file and handout
GMP090611E - MP3 audio file and Handout materials
Application of Design Review
Miguel Montalvo is President of Expert Validation Consulting, Inc. and has over two decades of professional/management experience in the areas of Quality, Validations and Technical Services within the traditional pharmaceutical, biotechnology and medical device industries. He has extensive expertise on development and implementation of quality functional procedures (QA/QC), GMP/QSR compliance audits (internal, supplier, external audits), remediation projects with companies on consent decrees, Quality Systems, handling of non-conformances (OOS, investigations and deviations), Process/Cleaning/Computer Systems/Equipment/Facility validations and their maintenance, change control, CAPA, international GMP compliance, Calibrations, Risk Management, operational compliance assessments/Gap Analysis and start-up of manufacturing facilities.
Miguel is a well recognized international speaker on Compliance, Validation and Quality related topics. He has authored papers in several publications including the Journal of Validation Technology and the American Pharmaceutical review magazine. He is a co-author on the API Facility Chapter on the book “Good Design Practices for GMP Pharmaceutical Facilities” published in 2005.