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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, February 03, 2015
Good Lab Practices: FDA and EPA Regulations
Location:
  Validation Academy
Description:   Develop an understanding of the documentation guidelines required for the generation of acceptable EPA and FDA product registration safety studies. A series of exercises, including a labeling exercise, a protocol review, and adherence to SOPs, reinforce course concepts.
Sponsor:  Validation Academy
Website:   http://conted.waketech.edu/schedule/
Sponsor Contact: 
 

Thursday, February 05, 2015
Good Lab Practices: FDA and EPA Regulations
Location:
  Validation Academy
Description:   Develop an understanding of the documentation guidelines required for the generation of acceptable EPA and FDA product registration safety studies. A series of exercises, including a labeling exercise, a protocol review, and adherence to SOPs, reinforce course concepts.
Sponsor:  Validation Academy
Website:   http://conted.waketech.edu/schedule/
Sponsor Contact: 
 

Saturday, February 07, 2015
HPLC in Theory & Practice
Location:
  Validation Academy
Description:   Learn about HPLC (High Performance Liquid Chromatography), a chemistry technique used to separate chemical compounds-of-interest from other compounds in a liquid sample. Topics will include an introduction to separation science and detection methods, types of HPLC, instrument orientation, operation, maintenance, and troubleshooting, as well as sample preparation and analysis.
Sponsor:  Validation Academy
Website:   http://conted.waketech.edu/schedule/
Sponsor Contact: 
 

Monday, February 09, 2015
Risk Based Approaches to Validation
Location:
  Validation Academy 850 Oval Drive, Raleigh, NC
Description:   Reduce the cost of validation and time-to-market of innovative products while ensuring product quality and patient safety by using risk-based approaches to validation. Review risk-based approaches as defined by the industry and regulatory organizations, their use and application, as well as ensuring a successful, safe, and compliant outcome. 9,10 MT 8am-5pm Room 124 David Grote
Sponsor:  Validation Academy
Website:  
Sponsor Contact: 
 

Monday, February 16, 2015
Elements of Current Good Manufacturing Practices
Location:
  Validation Academy
Description:   Expand your knowledge in the application of current good manufacturing practices (cGMP) in the production of biopharmaceuticals. An overview of topics will be covered from current regulations found in the selections of 210/211 of Title 21 of the Code of Federal Regulations (CFR) as well as the relevant ICH and FDA guidance documents
Sponsor:  Validation Academy
Website:   http://conted.waketech.edu/schedule/
Sponsor Contact: 
 

Tuesday, February 17, 2015
Elements of Current Good Manufacturing Practices
Location:
  Validation Academy
Description:   Expand your knowledge in the application of current good manufacturing practices (cGMP) in the production of biopharmaceuticals. An overview of topics will be covered from current regulations found in the selections of 210/211 of Title 21 of the Code of Federal Regulations (CFR) as well as the relevant ICH and FDA guidance documents
Sponsor:  Validation Academy
Website:   http://conted.waketech.edu/schedule/
Sponsor Contact: 
 

Tuesday, February 17, 2015
Riboprinter® Microbial Characterization
Location:
  Validation Academy
Description:   This course will focus on the operation of the Riboprinter®, proprietary instrumentation used to quickly and accurately characterize and identify bacterial isolates in the pharmaceutical and other FDA regulated industries. Lectures will address the biology enabling the technology and operation of the Riboprinter®. The laboratory sections will provide students with hands on experience using this instrument
Sponsor: 
Website:   http://conted.waketech.edu/schedule/
Sponsor Contact: 
 

Monday, February 23, 2015
Fundamentals of Cleaning Validation
Location:
  Validation Academy 850 Oval Drive, Raleigh, NC
Description:   This course will provide the basic understanding and fundamentals of cleaning validation utilized in the biotechnology and pharmaceutical industry. The course will follow the general lifecycle approach to cleaning validation with topics that will include: Types of cleaning, types of cleaning equipment, the use of cleaning agents, types of sampling, types of testing, general limits and calculation of those limits, cleaning validation documentation, cleaning monitoring programs, and change control as it relates to cleaning validation. This course will contain both lecture and hands on field execution. 23, 24 MT 8am-5pm Room 120 Michael Parks
Sponsor:  Validation Academy
Website:  
Sponsor Contact: 
 

Tuesday, February 24, 2015
5:30 PM
2015 Life Sciences Legislative Reception
Location:
  North Carolina Museum of History, 5 East Edenton Street, Raleigh, NC
Description:   NCBIO invites Members of the North Carolina General Assembly to join NCBIO members for an evening reception highlighting the State’s life sciences industry.
Sponsor:  North Carolina Biosciences Organization
Website:  
Sponsor Contact: 
 

Wednesday, February 25, 2015
Advanced Cleaning Validation
Location:
  Validation Academy 850 Oval Drive, Raleigh, NC
Description:   This course will build on the fundamentals of cleaning validation by expanding into development of cleaning programs utilized in the biotechnology and pharmaceutical industry. Topics that will be discussed include: mechanisms of cleaning biopharmaceutical soils, product changeover, soil cleanability studies, overview of CIP and equipment systems, contamination and other relevant aspects of a cleaning program. This course will contain both lecture and laboratory sections. 25,26 WTh 8am-5pm Room 120 Dr. Brian
Sponsor:  Validation Academy
Website:  
Sponsor Contact: 
 

Friday, February 27, 2015
11:00 AM
2015 SCITECH LECTURE Series
Location:
  Oak Grove Auditoriem-Forsyth Tech's Main Campus, 2100 Silas Creek Pkwy, Winston Salem, NC 27103
Description:   The Topic for this lecure will be "Regenerative Medicine: Current Concepts and Changing Trends." The featured speakers with be Anthony Atala, M.D., Director, Wake Forest Institute for Regenerative Medicine.
Sponsor: 
Website:  
Sponsor Contact:  Mona Cofer, 336.734.7205 or mcofer@forsythtech.edu
 

Monday, March 02, 2015
Computer Application Validation
Location:
  Validation Academy 850 Oval Drive, Raleigh, NC
Description:   Interactively learn and apply requirements in validating Computer System Applications. By concentrating on information systems and instruction on how to meet requirements of CFR 21, Part 11 Electronic Records, Electronic Signatures, the course includes how to test systems security, data integrity, backup and recovery. Hands-on exercises allow students to use validation principles through assessments to determine the level of validation required, writing validation plans, protocols, executing protocols, and analyzing results. Case studies and simulated validation deviations allow participants to experience real-life situations while honing problem-solving skills.
Sponsor:  Validation Academy
Website:  
Sponsor Contact: 
 

Tuesday, March 03, 2015
CED Life Science Conference 2015
Location:
  Raleigh Convention Center
Description:   CED Life Science Conference 2015 will feature: • Insights from world-class life science entrepreneurs • Analysis of new models in life science innovation • Can't-miss pitches from leading entrepreneurial companies • Hundreds of VC, Angel and Corporate Investors looking for the next big idea
Sponsor:  CED Life Science
Website:   http://www.cednc.org/lifescience/
Sponsor Contact: 
 

Saturday, March 07, 2015
Validation Documentation
Location:
  Validation Academy 850 Oval Drive, Raleigh, NC
Description:   Learn fundamental principles of validation documentation, including the different types of documentation, the purpose of each, and how the FDA uses them to ensure compliance to GMPs. Samples and case studies provided. You will find out how to identify documents for Validation Master Plans and execute a formal documentation review.
Sponsor: 
Website:  
Sponsor Contact:  Validation Academy
 

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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