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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. 


Monday, November 03, 2014
Validation of Automated Equipment & Process Control Systems (Section #126766)
Location:
  Valadation Academy
Description:   Learn the process for validation of automated equipment and process control systems typically found in biomanufacturing or pharmaceutical facilities using GAMP 5 and other guidelines. Highly interactive activities, including discussion of case studies and hands-on development of documentation, are provided. (Instructor-Timothy Tice)
Sponsor:  Validation Academy
Website:  
Sponsor Contact: 
 

Thursday, November 06, 2014
Carolina NMR Symposium
Location:
  David H. Murdock Research Institute, 150 Research Campus Drive, Kannapolis, NC 28081
Description:   The aim of the symposium is to create a forum for scientific discussion related to the field of NMR spectroscopy research in the Carolinas and surrounding area.
Sponsor: 
Website:   http://dhmri.org/news-events/events
Sponsor Contact:  DHMRI & ACS
 

Thursday, November 06, 2014
Process Validation for Biopharmaceutical Manufacturing (Section #126771)
Location:
 
Description:   This course reviews the regulatory requirements and methods for validating pharmaceutical and biopharmaceutical manufacturing processes. Topics covered, include: The history of Process Validation; Risk based analysis; QbD (Quality by Design); PAT (Process Analytical Technology); DOE (Design of Experiments); Process optimization and characterization. (Instructor- Dr. Mark Witcher)
Sponsor: 
Website:   http://conted.waketech.edu/schedule/
Sponsor Contact:  Validation Academy
 

Thursday, November 06, 2014
11:00 AM
AD Stemcell Conference
Location:
  Duke University Medical Center, Searle Center
Description:   Worldwide, over 40 million people have dementia due to Alzheimer’s disease and some 100 million older adults are estimated to be at increased risk (preclinical disease) for future dementia. Stem cells hold great promise for regenerating neural tissue, disease modeling and drug discovery but also raise new questions for regulators, ethicists, scientists, physicians and industry. Join us for this exciting workshop, featuring some of the nation’s leading experts, to discuss these exciting new developments.
Sponsor:  The Karen L. Wrenn Family Trust
Website:   http://adstemcellconference.com/index.html
Sponsor Contact:  hunsbergerjg@gmail.com
 

Monday, November 10, 2014
Basic Concepts of Validation (Section #126772)
Location:
  Validation Academy
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. (Instructor- Dr. Brian Nunnally)
Sponsor:  Validation Academy
Website:   http://conted.waketech.edu/schedule/
Sponsor Contact: 
 

Tuesday, November 11, 2014
The 16th Annual southeast Bio Investor& Partnering Forum
Location:
  W Atlanta Midtown, Atlanta, Georgia
Description:   The Southeast BIO (SEBIO) Investor & Partnering Forum provides an unparalleled opportunity for companies to meet key decision makers in the regional and national life science and medical technology communities. We expect about 350 biotech and medtech investors, corporate executives, university representatives, entrepreneurs and service providers to attend the event. This is a perfect opportunity to showcase your company’s products and services at the most significant annual life science event in the Southeast.
Sponsor:  SEBIO 2014
Website:   http://southeastbio.org/investorforum/2014/default.aspx
Sponsor Contact:  770-573-2839
 

Wednesday, November 12, 2014
Instrumentation Calibration Program for the Life Science Industry (Section #126774)
Location:
  Validation Academy
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. (Instructor- Andy Ferrell)
Sponsor:  Validation Academy
Website:   http://conted.waketech.edu/schedule/
Sponsor Contact: 
 

Thursday, November 13, 2014
Steam Sterilization Validation for Autoclaves and SIP Systems (Section #126777)
Location:
  Validation Academy
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. (Instructor- Russell Ciliento)
Sponsor:  Validation Academy
Website:   http://conted.waketech.edu/schedule/
Sponsor Contact: 
 

Friday, November 14, 2014
Leading Investigations into Foreign Particulate Matter (Section #126894)-
Location:
  Capstone Center
Description:   This course will provide an overview of current FPM detection techniques and how to couple them with a newer characterization regimen inspired by criminal trace evidence analysis. It guides attendees through the different phases of characterization and how to use these in a holistic, proactive program for FPM issue remediation. Attendees will be challenged by two hands on sessions where they will be responsible for documenting FPM attributes by different inspection methods and by isolating the particulate with provided tools. This type of program heightens efficiency of FPM investigations which ultimately saves cost by decreasing delayed release time and lost product. (Instructor- Karen Smith)
Sponsor: 
Website:   http://conted.waketech.edu/schedule/
Sponsor Contact: 
 

Monday, November 17, 2014
Fundamentals of Cleaning Validation (Section #126773)
Location:
  Validation Academy
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. (Instructor- Michael Parks)
Sponsor: 
Website:   http://conted.waketech.edu/schedule/
Sponsor Contact:  Validation Academy
 

Monday, November 17, 2014
Aseptic Processing II (Section #126895)
Location:
  Capstone Center
Description:   Delve more deeply into the Aseptic Processing arena with intensive hands-on instruction of aseptic techniques in a simulated cGMP environment. Instruction includes process simulations of filtrations, hand filling, semi-automated filling, release testing of final product and deviation investigations. Topics of classroom instruction include FDA regulations pertaining to Process Simulations, review of microbiology, water system review, and investigational technique. Completion of Aseptic Manufacturing Level 1 or at least 2 years of clean room experience are recommended. (Instructor- Dr. Krisstina Burgess)
Sponsor: 
Website:   http://conted.waketech.edu/schedule/
Sponsor Contact: 
 

Monday, November 17, 2014
Medical Device Current Good Manufacturing Practices (Section #126906)-
Location:
  Capstone Center
Description:   This course will instruct students in the principles, requirements and expectations of the U.S. F.D.A application of current Good Manufacturing Practices (cGMP’s) to medical device production. Included in the course contents will be regulatory definition of what constitutes a medical device, the divisions of FDA that oversee medical device applications and compliance, as well how the regulatory risk-based categorization of medical devices effects the scope of cGMP’s applied to various types of medical device products. (Instructor- Dr. Bernard Adkins)
Sponsor: 
Website:   http://conted.waketech.edu/schedule/
Sponsor Contact: 
 

Wednesday, November 19, 2014
Advanced Cleaning Validation (Section #126775)
Location:
  Validation Academy
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. (Instructor- Dr. Brian Lloyd)
Sponsor: 
Website:   http://conted.waketech.edu/schedule/
Sponsor Contact:  Validation Academy
 

Monday, December 08, 2014
7:30 AM
DCRI Informatics Conference
Location:
  Durham, NC
Description:   The Duke Clinical Research Institute (DCRI) brings leaders together to discuss critical health sector topics and to provide impetus for positively shaping the global health care community. In addition to strengthening relationships between Duke University and leading health-related organizations, these conferences bring to light many of the dynamic trends shaping the health care segment today and provide opportunities for senior health care leaders to shape future solutions and outcomes.
Sponsor:  Duke Clinical Research Institute
Website:   http://www.dcrievents.org/
Sponsor Contact:  ana.quinn@duke.edu
 

Tuesday, December 09, 2014
Microbial Contamination Control in Bioprocessing Operations
Location:
  NCSU, BTEC
Description:   Gain a fundamental understanding of sources of microbial contamination in biopharmaceutical manufacturing. Learn how to evaluate contamination risks and implement corrective and preventative measures to ensure a state of microbiological control in facilities and processes. Learn about recent regulatory expectations for control of contamination.
Sponsor:  NCSU
Website:   http://www.btec.ncsu.edu/industry/short_courses/microbial.php
Sponsor Contact:  Melody_Woodyard@ncsu.edu
 

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:  
Sponsor Contact: 
 

 
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