It was observed that there are misunderstanding between design intent HVAC designer and User (who is working on the field) where each party is focusing on his area! HVAC designer focus on the Engineering design aspects and User (on the other side) focus on cGMP aspect!!, in this course we will discuss the cGMP HVAC design criteria that could be create a base and common understanding between two parties and finally achieve ideal common understanding.
This course will address that Implementing ideal cGMP criteria when designing HVAC in conjunction with GEP requirement is essential so that the facility will achieve better compliance and in the same time will avoid mistakes that could be raised during lifecycle of the systems.
Areas Covered in the Session:
- GMP Fundamentals of Pharmaceutical HVAC System
- This part will discuss the benefits of HVAC system in pharmaceutical industries as well as discussing the contamination sources that must be prevented where this section will give information about how bad HVAC can be risky on both process or humane comfort as well
- Introduction about the cGMP Design Concept for HVAC system
- This part will give introduction about the Impact assessment on HVAC system, and will also discuss the main User requirement specifications (URS) and design criteria needed to be considered when designing new cGMP HVAC system that in turn will meet with intended purposes that are relevant to pharmaceutical process. This section will also address some HVAC layouts example detailing configuration for design of different pharmaceutical dosage forms within pharmaceutical plants.
Who Will Benefit:
- Validation scientists /Engineer
- HVAC Engineers
- Engineering quality assurance specialists
- Professionals from service organizations and vendors who serve pharmaceutical clients
- Regulatory personnel involved in pharmaceutical industries.
- Pharmaceutical Project Manager
- Sterile/Non sterile Manufacturing team
Speaker Profile:
He worked with different departments within Pharmaceutical Engineering Fields, During his experience for the last 16 years, he had implemented different GxP concepts including: Engineering Designs; Setup Project Policy & Engineering Quality systems; Implementation of Equipment Qualification and Calibration for: Production Systems, Facilities Management and Infrastructures ,utilities for both sterile/ non-sterile facilities as well as API’s facilities ; along with his experience for preparation and attendance different inspections by local/international authorities (FDA,EU and Local …..And others.)
Contact Detail:
NetZealous - Compliance4All,
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA.
Phone: +1-800-447-9407
Email: support@compliance4All.com
http://www.compliance4all.com/
Event Link : http://bit.ly/1Fenw4m
Comments