RAPS Pre-Approved Webinar on “Pharmaceutical and Biologics Facility Design: FDA and Regulatory Asp
Summary:GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on the topic, €Pharmaceutical and Biologics Facility Design: FDA and Regulatory Aspects€ on November 6. This 60-minute webinar earns up to 1.0 RAC credits towards a participant's RAC recertification upon full completion. John R. Godshalk, Senior Consultant at Biologics Consulting Group will be the Speaker at this session.
-----------------------------------------------------------------------------------------------------------------
Description:
Pharmaceutical and biologics facilities have to be designed in accordance with the compliance requirements set out by the FDA and other regulatory bodies. Like all other aspects of this industry, facility design too, has best practices.
This webinar will talk about these. It will give an introduction to best practices in pharmaceutical and biologics facilities with an emphasis on regulatory requirements. That is, it will familiarize participants with how to implement best practices that also comply with regulatory requirements, along with the reasoning for a particular type of design.
It will offer detailed examples of elements of facility design such as floorplans and flows (people, equipment, etc.), and specifics for fixtures, finishes, HVAC and other design aspects of cleanrooms in terms of current practices and GMP requirements. It will also offer examples ofdesign choices for pressurization, flows and HVAC zones along with their possible application. This session will also discuss design specifications for both open and closed systems along with current standards.
By the end of the session, participants will have gained an understanding of what is important for a facility from the FDA and regulatory perspective. They will get an idea of what the FDA looks for in their facility in terms of design and flow patterns during an inspection. As a result of the knowledge gained from this webinar; participants will be able to get their facility design errors to a minimum. It is important to do this at the time of design, because trying to fix problems later, when the facility has been built, is far more expensive.
-----------------------------------------------------------------------------------------------------------------
When:November 6, 10:00 AM PDT | 01:00 PM EDT
-----------------------------------------------------------------------------------------------------------------
By whom: John R. Godshalk, MSE, MBA, is a Senior Consultant at the Biologics Consulting Group.
John served as a Senior Review Biochemical Engineer and Lead cGMP inspector in the Divisionof Manufacturing and Product Quality at the Center for Biologics Evaluation and Research(CBER), Food and Drug Administration (FDA) for over three. Prior to joining FDA he worked asa management consultant after obtaining his MBA.
John has experience with products that include drugs,drug/device combination products, viral and bacterial vaccines, recombinant therapeutic andfractionation products, in vitro diagnostic test kits, and 510K medical devices. His inspectionexperience includes leading inspections of active pharmaceutical ingredient manufacturers,aseptic filling and finishing facilities, and contract manufacturers.
John has provided advice to industry on regulatory strategies, pharmaceutical product facility design, best practices, and validation approaches that meet FDA licensing requirements. He currently works to assist clients inthe areas of cGMP, regulatoryaffairs and management consulting.
-----------------------------------------------------------------------------------------------------------------
For whom:
The webinar will benefit
o Compliance Manager
o Facility Manager
o Validation Manager
o Regulatory Manager
o Design Team/Architects
----------------------------------------------------------------------------------------------------------------
Duration: 60 minutes
-----------------------------------------------------------------------------------------------------------------
To enroll for this webinar, contact
webinars@globalcompliancepanel.com
Phone: 800-447-9407
-----------------------------------------------------------------------------------------------------------------
Description:
Pharmaceutical and biologics facilities have to be designed in accordance with the compliance requirements set out by the FDA and other regulatory bodies. Like all other aspects of this industry, facility design too, has best practices.
This webinar will talk about these. It will give an introduction to best practices in pharmaceutical and biologics facilities with an emphasis on regulatory requirements. That is, it will familiarize participants with how to implement best practices that also comply with regulatory requirements, along with the reasoning for a particular type of design.
It will offer detailed examples of elements of facility design such as floorplans and flows (people, equipment, etc.), and specifics for fixtures, finishes, HVAC and other design aspects of cleanrooms in terms of current practices and GMP requirements. It will also offer examples ofdesign choices for pressurization, flows and HVAC zones along with their possible application. This session will also discuss design specifications for both open and closed systems along with current standards.
By the end of the session, participants will have gained an understanding of what is important for a facility from the FDA and regulatory perspective. They will get an idea of what the FDA looks for in their facility in terms of design and flow patterns during an inspection. As a result of the knowledge gained from this webinar; participants will be able to get their facility design errors to a minimum. It is important to do this at the time of design, because trying to fix problems later, when the facility has been built, is far more expensive.
-----------------------------------------------------------------------------------------------------------------
When:November 6, 10:00 AM PDT | 01:00 PM EDT
-----------------------------------------------------------------------------------------------------------------
By whom: John R. Godshalk, MSE, MBA, is a Senior Consultant at the Biologics Consulting Group.
John served as a Senior Review Biochemical Engineer and Lead cGMP inspector in the Divisionof Manufacturing and Product Quality at the Center for Biologics Evaluation and Research(CBER), Food and Drug Administration (FDA) for over three. Prior to joining FDA he worked asa management consultant after obtaining his MBA.
John has experience with products that include drugs,drug/device combination products, viral and bacterial vaccines, recombinant therapeutic andfractionation products, in vitro diagnostic test kits, and 510K medical devices. His inspectionexperience includes leading inspections of active pharmaceutical ingredient manufacturers,aseptic filling and finishing facilities, and contract manufacturers.
John has provided advice to industry on regulatory strategies, pharmaceutical product facility design, best practices, and validation approaches that meet FDA licensing requirements. He currently works to assist clients inthe areas of cGMP, regulatoryaffairs and management consulting.
-----------------------------------------------------------------------------------------------------------------
For whom:
The webinar will benefit
o Compliance Manager
o Facility Manager
o Validation Manager
o Regulatory Manager
o Design Team/Architects
----------------------------------------------------------------------------------------------------------------
Duration: 60 minutes
-----------------------------------------------------------------------------------------------------------------
To enroll for this webinar, contact
webinars@globalcompliancepanel.com
Phone: 800-447-9407
Source...