A Message from the
NEWSLETTER
DECEMBER 2015, NUMBER 4
BOARD OF DIRECTORS
Amber Myers; President
Burns & McDonnell
(816) 807-0308
ammyers2@burnsmcd.com
Ricardo Jimenez; Vice President
Lonza
(713) 568-6190
James Harrell; Treasurer
Design Group
(254) 315-6483
James.harrell@BWDesignGroup.com
Richard Moore; Secretary
CRB
(847) 452-5918
Tim Glasson; Past President
AM Technical Solutions
(214) 287-0432
President
Exciting new things are coming in 2016!
Some of the best news for our chapter is the potential for
creating one overarching Student Chapter that would
interact with the each Affiliate / Chapter. With the large
geographical region of the South Central Chapter, this
would give students in our area a better opportunity for
engagement in ISPE. If you are a student, or if you know a
student in this region who is interested in joining ISPE or
representing our chapter in the Student Poster
Competition, please reach out to me for more
information.
I had the pleasure of attending our joint Tri-Chapter
Mingle reception at the Annual Meeting. Members of the
South Central, Midwest and Great Lakes chapters met for
an informal networking social. We were able to discuss
common interests and concerns within the industry, meet
new people and learn from other chapters what their
members find most beneficial. We hope to implement
some of these new ideas into our chapter next year. This
was such a success that our chapters look forward to
more partnering opportunities in the future!
Fun Fact:
In the UK, it is illegal to eat mince pies on Christmas Day!
If you missed the ISPE Annual Meeting,
here are the “Cliffs Notes”…
The Facility of the Year Award went to
AstraZeneca
China!
 The BRAND NEW and highly anticipated Drug
Shortage Assessment and Prevention Tool was
unveiled.
 The FIRST EVER Global Regulatory Town Hall
The deadline has
passed for 2016
Nominees, but it is
never too early to
begin planning your nomination for 2017.
Deadlines will be November 2016.
was kicked off by 10 FDA and global regulators. In
addition to discussion surrounding the EMA’s
PRIME program, attendees were able to receive
first-hand and immediate feedback to some of the
industry’s most pressing issues, like:
o Drug Shortages
o Increased Transparency
o Data Integrity
o Quality Metrics
o Risk-Based Streamlining
 The Student Poster Competition winners
were:
Undergraduate Winner
Neeraja Ravi of the University of California,
o
San Diego, San Diego Chapter; “Traction Forces
Regulate Early Fate Decisions in Embryonic Stem
Cells”
Graduate Winner
Sydney Shaw of Northeastern University,
o
Boston area Chapter; “The effect of light,
jasmonate, and tissue organization on the
expression of the vindoline pathway genes in
Catharanthus roseus”
The 2016
Annual Meeting will be in
Atlanta, Georgia
I September 18-24 I
Register Now!
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Upcoming ISPE training…
January  Basic Principles of Computerized Systems
Compliance Using GAMP® 5, Including Revised
Annex 11 and Part 11 Update (T45)
 A GAMP® Approach to Data Integrity, Electronic
Records and Signatures, and Operation of GxP
Computerized Systems (T50) – New Course!
February –
 HVAC (T14)
 Applying the Biopharmaceutical Manufacturing
Facilities Baseline® Guide Principles (T31)
 Practical Implementation of Process Validation
Lifecycle Approach (T46)
 Process Validation in Biotechnology
Manufacturing (T32)
 Practical Application of Technology Transfer (T19)
 GMP Auditing for the Pharmaceutical Industry
(G07)
 Science and Risk-based Commissioning and
Qualification - Applying the ISPE Good Practice
Guide: Applied Risk Management for Commissioning
and Qualification (T40)
 A Risk-Based Approach to GxP Process Control
Systems: Applying the GAMP® Good Practice Guide:
A Risk-Based Approach to GxP Process Control
Systems (2nd Edition) (T21)
March –
 Practical Application of Computerized Systems
Compliance: Applying the GAMP® 5 Guide: A Riskbased Approach to Compliant GxP Computerized
Systems (T11)
 Applying Quality Risk Management (QRM) (T42)
 Risk-Based Verification of Facilities, Systems and
Equipment Workshop (T48)
 Cleaning Validation Principles (T17)
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