America's Top Tradeshow Directory | Events In America
Facebook Linked In Twitter Videos

Event Contacts


Event Manager
Compliance4all
161 Mission Falls Lane, Suite 216
Fremont, CA 94539
(800) 447-9407

Event Description

Overview:
This course explores some of the best practices of pharmaceutical facility design with an emphasis on regulatory aspects. FDA and other global regulatory body requirements are discussed and the reasoning behind them.

Examples of floorplans and flows (people, product, etc.) are examined and discussed. Specifics for fixtures, finishes, HVAC and other design aspects of cleanrooms are discussed in terms of current practices and GMP requirements. Examples of design choices for pressurization, flows and HVAC zones are given along with their possible application. Design specifications for both open and closed systems are discussed along with current standards.

Why should you Attend:
The attendee will learn what is important in facility design from the FDA and regulatory standpoint. The attendee will understand what FDA looks for during a facility inspection. The attendee will be able to minimize possible design errors which are difficult and expensive to fix post-build. The attendee will understand what FDA looks for in reviewing the facility design and the flow patterns.

Areas Covered in the Session:
Best design practices for Pharma facilities
Best design practices for biologics facilities
Regulatory compliance for Pharma and biologics facilities design
Flow patterns and cross contamination controls
Design criteria for fixtures and finishes
Examples of good design
General specifications for different classification zones
Examples of design specs for cleanrooms

Who Will Benefit:
Compliance Manager
Facility Manager
Validation Manager
Regulatory Manager
Design Team/Architects

Speaker Profile:
John R. Godshalk currently works for the Biologics Consulting Group as a Senior Consultant. John served as a Senior Review Biochemical Engineer and Lead cGMP inspector in the Division of Manufacturing and Product Quality at CBER, FDA. He contributed to formulation of FDA policy.

Contact Detail:

Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com
http://www.compliance4all.com/
Event Link : http://www.compliance4all.com/control/w_product/~product_id=500884LIVE?channel=mailer&camp=webinar&AdGroup=eventsinamerica_Dec_2016_SEO
Twitter Follow us – https://twitter.com/compliance4all
Facebook Like us – https://www.facebook.com/Compliance4all
LinkedIn Like us – https://www.linkedin.com/company/compliance4all

Not sure if you want to exhibit at or attend the Training by Compliance4all on FDA and Regulatory Aspects? See the panels below to get the information you need to make an informed decision.

All information in Events In America is deemed to be accurate at the time we add it, and we take steps to verify all details and update our records when new information is provided, but as people, events and circumstances change, we caution users to independently confirm all information. EventsInAmerica.com and Events In America LLC make no guarantee of accuracy and assume no liability for inaccurate information.

Event Details

Website: http://www.compliance4all.com/control/w_product/~product_id=500884LIVE...
Conference/Event Dates: 12/06/2016 - 12/06/2016
Conference/Event Hours: 60 Minutes
Classification: B2B
Primary Industry: Clinical Pharmacology
Other Industries: Clinical Pharmacology, Professional Healthcare
Cost to Attend: One Dial-in One Attendee Price: US$150.00
Audience: Compliance Manager
Facility Manager
Validation Manager
Regulatory Manager
Design Team/Architects
Number of Exhibitors:1

Booth Details

Booth Size Booth Cost   Available Amenities
No Exhibiting   Electricity: n/a
  Water: n/a
  Generator: n/a
  Marketing Vehicles Allowed: n/a
Other Booth Sizes Available: n/a

Advance Networking

How do I show up here?
 
Mark Travers

Personal Notes

Add a note here, it is only visible by you.

New Search Contact This Event