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 Calendar of Events

North Carolina's life science community enjoys a vibrant array of activities and events.  This list shows events of interest, including events hosted by NCBIO and other organizations involved in North Carolina's life science community. 


Tuesday, March 31, 2015
SEMDA 2015 Annual Conference
Location:
  Renaissance Waverly Hotel and Convention Center
Description:   The 9th annual Southeastern Medical Device Association Conference (SEMDA) is the premier forum fostering business and educational opportunities for investors, medical device companies, medical entrepreneurs, and related industry professionals in the Southeast. The 2015 Conference offers multiple opportunities for you to grow your business and make meaningful connections.
Sponsor:  Southeastern Medical Device Association
Website:   http://pitchrounds.semda.net/
Sponsor Contact:  admin@semda.net
 

Monday, April 06, 2015
Basic Concepts of Validation
Location:
  Validation Academy 850 Oval Drive, Raleigh, NC
Description:   Learn the use of a master validation plan, Installation Qualification (IQ), Operational qualification (OQ), and Performance Qualification (PQ) protocols, and the relationship of validation to Good Manufacturing Practices (GMPs). Through case studies and exercises, participants learn the fundamental requirements of preparing a validation protocol, analyzing data, and preparing a final report. FDA inspection expectations are also discussed.
Sponsor:  Validation Academy
Website:  
Sponsor Contact: 
 

Monday, April 06, 2015
Steam Sterilization Validation for Autoclaves
Location:
  Validation Academy 850 Oval Drive, Raleigh, NC
Description:   Provides participants with an in-depth understanding of steam sterilization as well as the current methods of validation for sterile processes in the pharma/biotech manufacturing environment, including Autoclaves and Steam in Place (SIP) Systems, by providing a thorough understanding of sterilization, sterile equipment design, the regulatory requirements associated with sterilization and the methods used to test and validate sterile processes
Sponsor:  Validation Academy
Website:  
Sponsor Contact: 
 

Wednesday, April 08, 2015
Validation of Controlled Temperature Environments
Location:
  Validation Academy, 805 Oval Drive, Raleigh, NC
Description:   This class provides a thorough understanding of controlled temperature environments, including design, regulatory requirements, and methods used to test and validate, with a focus on incubators, cold rooms, and freezers
Sponsor:  Validation Academy
Website:  
Sponsor Contact: 
 

Thursday, April 09, 2015
Fundamentals of Utility Systems: Design, Validation
Location:
  Validation Academy 850 Oval Drive, Raleigh, NC
Description:   This course reviews HVAC system fundamentals, providing an overview of critical parameters for products and processes that can be affected by HVAC. The course also covers pharmaceutical water, perhaps the most important of all pharmaceutical utilities. Regulatory requirements will be addressed including USP 26 and 27, the FDA Guide to Inspections of High Purity Water Systems, current FDA reviews, and current Good Manufacturing Practice (cGMP) requirements. Participants will take part in several interactive exercises and discussions that allow application of learned content to typical manufacturing processes.
Sponsor:  Validation Academy
Website:  
Sponsor Contact: 
 

Monday, April 13, 2015
Instrumentation Calibration Program for the Life
Location:
  Validation Academy 850 Oval Drive, Raleigh, NC
Description:   This course reviews the regulatory requirements and methods for determining calibration specifications and relates these methods to validation of critical utilities, manufacturing processes and laboratory testing instruments. Calibration documentation is presented including the different types of documentation, purpose of each document type, and how the documents are utilized by FDA for ensuring compliance to GMPs. Samples of document types are provided as case study examples of how documents are developed and used to ensure completion of validation. Course utilizes principles and practices outlined in ISPE GAMP Good Practice Guide: Calibration Management.
Sponsor: 
Website:  
Sponsor Contact:  Validation Academy
 

Monday, April 20, 2015
Analytical Method Validation
Location:
  Validation Academy 850 Oval Drive, Raleigh, NC
Description:   This course will instruct students in the principles of method validation, a regulatory requirement for the quality control of biopharmaceuticals. Included will be the requirements for the validation of an analytical method, the statistics needed, protocol development, validation execution and analysis of validation results. The course will contained both lecture and laboratory sections. The lab sections will allow the student hands-on experience with the planning and execution of the validation of a selected analytical method.
Sponsor: 
Website:  
Sponsor Contact:  Validation Academy
 

Monday, May 11, 2015
Validation of Upstream and Downstream Processes
Location:
  Validation Academy 850 Oval Park, Raleigh, NC
Description:   Course will provide a detailed overview of the series of activities required for validation of a biopharmaceutical process, which take place over the product lifecycle. Participants will gain a better understanding of the specific activities required for both upstream and downstream processing through interactive workshop exercises.
Sponsor:  Validation Academy
Website:  
Sponsor Contact: 
 

 
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