Ashley Saberniak receives ASQ CQIA Certification

For Immediate Release (Indianapolis, Indiana; March 4, 2016).  Performance Validation is pleased to announce that Ms. Ashley Saberniak has successfully completed certification as a Certified Quality Improvement Associate.

The Certified Quality Improvement Associate is a professional who understands quality tools and their uses and participates in quality improvement projects.  The CQIA requries two years of work experience and the minimum of an AS degree.  Formal certification requires the satisfactory completion of a 100-question three-hour examination.

Congratulations Ashely!

Mr. Bruce Beck, Appointed Board Advisor

Bruce E. Beck, Appointed as Board Advisor to Performance Validation’s Board of Managers

Performance Validation LLC (2015), I am pleased to announce the appointment of Bruce E. Beck to the position of Board Advisor to Performance Validation’s Board of Managers.  Mr. Beck brings extensive skills and experiences in leading and managing various types of groups in the pharmaceutical business.  His experience includes 34 years with Eli Lilly and Company with 15 of those years as Director of Engineering Global Facilities Delivery (GFD).  During his role as the lead for GFD, Mr. Beck successfully led the development and implementation of a corporate Commissioning and Qualification program that has been used in the delivery of neBruce Beckw and existing assets around the world.  Mr. Beck has been responsible for the delivery of both US and outside US facilities including China, Spain, Ireland, Italy, France, and the United Kingdom.

As a manager, Mr. Beck has provided coaching, mentoring, and leadership to his direct reports to enhance their skills in leading multicultural teams around the world.  A cornerstone of his success is based on the ability to focus on both technical expertise and leadership necessary to bring large capital projects to fruition.  His experience includes development of a best in class Commissioning and Qualification program.  Development and implementation of a Construction Quality Assurance program that delivered first time quality to capital projects effectively reducing rework on capital projects by 40-50%, and a program to address equipment lifecycle by creating a standardized maintenance package process to ensure that all newly acquired assets are maintained properly.

Mr. Beck has a BA in Chemistry from Asbury University and an MS in Chemical Engineering from The Ohio State University.  Mr. Beck is a published author on topics related to construction quality.

Stephanie Welte Promoted to Principal Validation Engineer

Indianapolis, IN (August 2015) Performance Validation, a nationwide leader in Stephanieproviding validation, commissioning, and quality services, today announced the promotion of Stephanie Welte to Principal Validation Engineer.

The Principal Validation Engineer advises clients on best industry practices; defines, plans and executes project work including research, evaluation, and/or solution development to achieve customer objectives; and lead project related functions defined by the customer in a manner that is consistent with Performance Validation’s values.

About Performance Validation
Founded in 1988, Performance Validation’s mission is to provide customers with peace of mind with respect to the management and accomplishment of project work in which they have been entrusted to complete. For more information about Performance Validation, visit its website at www.perfval.com.

Brad Henry
VP, Indiana Division Director
5420 W Southern Ave, Suite 100
Indianapolis, IN 46241
317-248-8848

Richard Van Doel PhD Candidate

Richard Van DoelI am very happy to announce that I have been promoted to PhD Candidate! At Indiana Wesleyan University to be promoted to a PhD Candidate means that I have satisfactorily completed all course work and the comprehensive oral examinations. Written the proposal, which consists of the first three chapters of my dissertation, and satisfactorily completed the dissertation proposal seminar.

The proposal seminar is conducted in a public forum, approximately 2 hours in length and consists of a 20-minute presentation of the proposal followed by questions from the dissertation committee, faculty members, and students. Being promoted to a PhD Candidate means that I can obtain IRB approval for my study and then commence with data collection.
It has been 4 years of work to get to this point, as I started my PhD journey in July 2011.

Originally, the program was an EdD, Doctorate in Education, however the program was accepted by the Higher Learning Commissioning as a PhD program starting in July 2014. This added two additional courses and required an additional mini-comprehensive examination to cover the additional course work. My dissertation proposal has been submitted to IWU’s Institutional Review Board for approval and once this is obtained, the next step is to commence data collection, data analysis in chapter 4 and interpretation of the findings in chapter 5. Once written the final step will be completion of the dissertation defense and graduation.

 

Matthew Hopson Receives ASQ-Certified Green Belt

Congratulations Matthew!

Milwaukee, Wis., 06/06/2015 — The Certification Board of ASQ is pleased to announce that Matthew Hopson has completed the requirements to be named an ASQ-Certified Six Sigma Green Belt, or ASQ SSGB.

As such, Matthew Hopson has reached a significant level of professional recognition, indicating a proficiency in and a comprehension of Six Sigma principles and practices. Individuals who earn this certification are allowed to use “ASQ SSGB” on their business cards and professional correspondence.

“Earning an ASQ certification is more than a great accomplishment – it’s a formal recognition of professionals that they have demonstrated an understanding of, and a commitment to, quality practices in their field,” said ASQ Chair Cecilia Kimberlin. “This distinction represents an investment in ones future and provides a competitive advantage to those who earn ASQ certifications.”

In order to sit for the Six Sigma Green Belt (SSGB) examination, an individual must have three years of work experience related to the Body of Knowledge. Certified SSGBs apply tools and techniques from the DMAIC model (define, measure, analyze, improve and control) while working on Six Sigma projects under the supervision of a Black Belt.

New Executive Director of IMDMC Named

PRESS RELEASE….August 22, 2014

Kathy Heuer IMDMC Executive Director

Kathy Heuer
IMDMC Executive Director

The Indiana Medical Device Manufacturing Council (IMDMC) announced today that State Representative Kathy Heuer, (R) Columbia City, has been hired as their Executive Director.

IMDMC serves to represent the interests of its member medical device companies in the delivery of innovative, life-changing technologies to patients. By uniting Indiana medical device manufacturers, IMDMC serves to amplify their voices and convey their interests before state and federal legislatures and regulatory agencies. As an association, IMDMC is dedicated to promoting education within their industry by bringing speakers of interest to regular educational forums.

The medical device industry in Indiana is one of the largest industry clusters in the nation, ranking as the 7th largest employer in the nation in the medical device industry. Memberships in IMDMC include Zimmer, Cook Medical, Medtronic, Roche Diagnostic , Hill-Rom, Boston Scientific, Biomet, Depuy, Paragon and Fort Wayne Metals among others.

Heuer, who served in the Indiana General Assembly as a State Representative since 2010, is a resident of Whitley County and has a background in business, education, sales and government policy. In the House of Representatives, she was Vice-Chair of the Local Government Committee, served on the Small Business, Commerce and Economic Development Committee and was a member of the Government Reform Committee. Heuer submitted her resignation to House Speaker Bosma effective August 20th.

Denis Johnson, IMDMC board president and Vice President of operations at Boston Scientific stated, “We are looking forward to having Kathy join us. As a state legislator she worked tirelessly for policies that would benefit our state, and we believe that as executive director of our organization, she will be able to transfer those skills to our specific industry at both the state and federal level.”

ASTM E55: Single Use Systems/ Raw Materials Workshop Summary

The presentations from ASTM International’s E55 Manufacture of Pharmaceutical Products Raw Materials in Biopharmaceuticals Workshop which took play May 21, 2014 in Boston, Massachusetts at Vertex Pharmaceuticals are posted to the E55 Committee Documents page (available to non-members here).

The Single Use Systems (SuS) Raw Materials Workshop was attended by over 60 international representatives with presenters from major biopharmaceutical companies, users, material suppliers and regulators to discuss the use of standards to support raw materials; the supply chain, change control management and systems qualification; extractable testing (SUT); single use technology and standards. Also included in the days discussions were some case studies on independent testing groups. This workshop did not only give successful direction to the two aforementioned draft standards but also helped users and suppliers come to a clear consensus on the future approach of two New Practice standards.

  • WK43975 for determining and characterizing extractables from materials used in single-use applications.
  •  WK43739 for Process to Remove Virus by Filtration using 20-nm Retentive Viral filter.

Related to the afternoon presentations, technical subcommittee E55.04 General Biopharmaceutical Standards is currently working on two new E55 ASTM International consensus standards expected to go to ballot this summer.

  • The first draft standard is WK43741Standard Practice for testing integrity of single-use systems (SuS) which covers an approach for testing the integrity of single-use systems consisting of single-use components used in pharmaceutical development and manufacturing.
  • The second standard is WK43742Standard Practice for characterizing particulates burden from single-use systems (SuS) which covers an approach for determining particulates burden from single-use systems for applications in pharmaceutical development and manufacturing, notably biotechnology.

The collaboration of industry during this workshop on these important topics covering biopharmaceuticals, raw materials and single use systems proved a truly cooperative effort to move the industry forward with a safer, more proficient approach in mind. It was great to hear all the different perspectives from the presenters and the attendees.

If you would like to get involved with any of the task groups, please consider joining ASTM and becoming a Member of E55. To hear about the benefits of your participation from those in industry, click here. It’s much more fun than reading it!

Any questions related to these efforts can be directed to E55’s point of contact at ASTM:

Best regards,

Christine DeJong
Manager, Technical Committee Operations
ASTM International
T: 610-832-9736
E: cdejong@astm.org

Stephanie Welte – Receives ASQ Certified Quality Auditor Certification

For Immediate Release (Indianapolis, Indiana; June 16, 2014).  Performance Validation is pleased to announce that Ms. Stephanie Welte has successfully completed certification as a Certified Quality Auditor.

The Certified Quality Auditor is a professional who understands the standards and principles of auditing and the auditing techniques of examining, questioning, evaluating and reporting to determine a quality system’s adequacy and deficiencies. The Certified Quality Auditor analyzes all elements of a quality system and judges its degree of adherence to the criteria of industrial management and quality evaluation and control systems.  Certification is obtained by successfully completing a 150 question examination administered by the American Society for Quality.

 

Derek Fraits – Receives LEED Green Associate Certification

For Immediate Release (Indianapolis, Indiana; June 12, 2014).  Performance Validation is pleased to announce that Mr. Derek Fraits has successfully completed certification as a LEED Green Associate.

The Green Building Certification Institute administers this certification process.  The LEED Green Associate credential is for professionals who want to demonstrate green building expertise in non-technical fields of practice.  This credential denotes basic knowledge of green design, construction, and operations.  This knowledge is certified through a comprehensive 2-hour written examination.

ISPE-FDA 3rd Annual GMP Conference

Performance Validation will be attending and exhibiting at the ISPE-FDA 3rd Annual GMP Conference June 2-4 at the Baltimore Hilton.  UPDATE! We will be at Booth 28 in the Exhibition Hall, I look forward to seeing you there – Rick

CGMP_300x130_exhibit

The Keynote Speakers include:
Janet Woodcock, M.D. Director FDA/CDER. Ms. Woodcock will be addressing bringing manufacturing, science and quality to the next level.

Mary Oates, Ph.D VP Global Quality Operations, Pfizer. Ms. Oates will be addressing implementing and measuring a culture of quality.

Gerald Heddel, Director, Inspection Enforcement & Standards Division, MHRA, UK. Mr. Heddell will be addressing European perspective on data integrity.

David Smith, Executive VP, Global Operations & IS, AstraZeneca UK. Mr. Smith will be addressing approaches in assuring reliable supply from India.

The final Keynote speaker is Ilisa Bernstein, Deputy Director of Compliance, FDA/CDER. Ms. Bernstein will address global supply and emerging markets.

Representatives from Performance Validation will be present to share our success stories and how we have assisted Pharmaceutical and Medical Device companies in meeting GMP compliance. I hope to see you there.

Please contact Rick Van Doel, President, Performance Validation if you would additional information on Performance Validation or if you would like to set an appointment to discuss how Performance Validation may assist you.