Combination Products – ISPE 2016

Performance Validation has the proven knowledge and experience to support the delivery of your cutting edge medical devices, drug and combination products to market.  Whether it’s assistance ith the development/qualification of process parameters for a Bi-Layer tablet press, to providing technical assistance for the design of a pen injection assembly process, PC is your one stop validation provider.

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PV has you covered

Performance validation provides peace of mind by supporting your project needs from start to finish; from assisting with the delivery of user requirements that ensure the success of your project, to providing the validation documentation needed to address regulatory agency requirements (FDA. EMA, etc…)  When working with with combination products, our knowledge and expertise with 21 CFR Part 210/211 and 820 allows us to provide the guidance needed to ensure that you are meeting both device and drug regulatory requirements.

If you are attending the 2016 ISPE annual meeting September 18-20, in Atlanta GA please stop by Booth 818 to meet members of the Performance Validation team to learn about our expertise and how we might be able to help you on your current or future project.

We hope to see you there!

PDA Midwest Sept 2016 Dinner Meeting

(Indianapolis, Indiana, August 2016) Performance Validation will be attending and exhibiting at the PDA Midwest Sept 2016 Dinner Meeting.  The meeting will be held on September 7, 2016 5 to 8 PM at the Crowne Plaza in Northbrook, IL.

For this event there are two topics.  The first speaker is Dr. Resatz, President Vetter Development Services, USA who will be presenting the topic: General Considerations for Manufacturing GMP Compliant Phase 1/2 Investigational Medicinal Products.  The second speaker is David Dolgin, Senior Validation Consultant, PSC/BioTechnique LLC, who will be presenting the topic: lllustrative Example: Use of Phase 1/2 IMP Data and Experience in Process Design and Qualification.

Mike SMike Stires will be representing Performance Validation at this event.  Mike is an owner for Performance Validation and a Principal Validation Engineer responsible for oversight of all work originating out of PV’s Illinois office.  Have a question on commissioning, qualification or validation? Mike and his team will be available to answer your questions during the networking breaks.  Alternatively, you can contact Mike directly via email to schedule a meeting.

We hope to see you at the PDA Midwest Sept 2016 Dinner Meeting!

About Performance Validation – Performance Validation has been serving the life science industries since 1988, and is a nationwide leader in providing commissioning, qualification, and validation, services for pharmaceutical, biotechnology, and medical device manufacturers. We live by our Mission, which is to provide our clients with peace of mind, and we have been doing so for more than 25 years.

Meet PV at the ISPE Annual Meeting

Meet PV’s Environmental Mapping Manager at the ISPE Annual Meeting


Critical Temperature and Humidity? PV can map it!



Indianapolis, IN (August 2016) – Will you be attending the 2016 International Society of Pharmaceutical Engineering (ISPE Annual Meeting) Annual Meeting September 18-20, in Atlanta GA?


If YES, please plan to stop by Booth 818 to meet members of the Performance Validation team to learn about our expertise and how we might be able to help you on your current or future projects.


Neil Enlow, Performance Validation’s manager of our Environmental Mapping Services (Indianapolis office) will be in attendance. Please contact Neil to set up an appointment to learn about Performance Validation’s competitive Temperature and Humidity Mapping solutions.




Performance Validation has a flexible support model. PV can provide staff, or equipment support to complement your in-house team, support the outsourcing an entire project, or simply provide equipment rental for your use. Let us know how we can help.


Performance Validation’s equipment is maintained in a calibrated and validated state. We use industry known and accepted Vaisala Veriteq VL-1000/2000® Data Loggers and Kaye Validator® Systems. Our equipment inventory also includes self contained biological indicators and an incubator for verification of sterility processes. Our internal procedures have been developed to govern the use of equipment to ensure a consistent approach to set up, use, and data retrieval.

PV Partners with C&F as a Value Added Reseller for Adaptive GRC

Indianapolis (August 2016) Performance Validation is pleased to announce their partnership with C&F as a Value Added Reseller of C&F’s AdaptiveGRC solution across the United States.

As a Value Added Reseller, Performance Validation will provide First Level Support to C&F’s US customers, providing support for customer inquiry, configuration, and validation of the AdaptiveGRC solution.

“We believe that expanding our portfolio with the AdaptiveGRC solution will allow us to bring additional value to our customers”, said Richard Van Doel, President at Performance Validation. “Pharmaceutical manufacturers, device makers and biotechs are subject to multiple regulations and standards. Ability to track the state of compliance effectively is a must-have requirement. Using AdaptiveGRC simplifies management of the compliance status and saves lots of time.”

About Adaptive GRC:
AdaptiveGRC by C&F is a synchronized governance, risk management and compliance solution suite.  The AdaptiveGRC platform is engineered with a single data source and zero data replication, which provides a more effective and efficient approach in monitoring and reporting GRC activities.

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  • Multi-regulation Governance, Risk and Compliance platform for the Life Science industry
  • Quick to start, flexible to change as you grow and always there to support your needs
  • Superior GRC data management capabilities

About C&F:
C&F is a team of passionate people working around the globe. We combine business and process insight with our technology expertise to develop state-of-the-art IT solutions. We specialize in Life Sciences and beyond, with years of GRC expertise spanning across multiple industries where security is of the highest importance.

About Performance Validation, LLC:
Performance Validation, LLC is a veteran owned company that has been providing commissioning, qualification, and validation services to the life sciences industry since 1988.  With offices in Indiana, Michigan, Georgia, Illinois, and Kansas our mission is to provide the Life Science industries with technical and consulting expertise to achieve and maintain a state of compliance.
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2016 ISPE Annual Meeting

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Going to the 2016 International Society of Pharmaceutical Engineering (ISPE) Annual Meeting September 18-21, in Atlanta GA?

If YES, please plan to stop by Booth 818 to meet members of the Performance Validation team to learn about our expertise and how we might be able to help you on your current or future projects.

We will have staff from our local Augusta, GA office, as well as the managers of our Environmental Mapping services (Indianapolis office) and Business Information Computer System Validation services (Kalamazoo MI office) in attendance.

Additionally, we will be demonstrating the Adaptive GRC Solution, which is a cost effective approach to Governance, Regulation and Compliance. Performance Validation is a Value Added Reseller of the Adaptive GRC solution.

Performance Validation – Temperature Mapping

Performance Validation Provides Competitive, Effective Temperature and Humidity Mapping Solutions to Wide Range of Industries

INDIANAPOLIS, June 14, 2016 /PRNewswire/ — Performance Validation is quickly making a name for itself in the environmental mapping industry. Storage chambers, warehouses, manufacturing facilities and laboratories are just a few environments where precise temperature and humidity control is an essential component of the operation, particularly in regulated life science fields. More information, including a collection of project summaries of recently completed temperature mapping projects, is available here.

Performance Validation maintains every piece of equipment in a calibrated and validated state to ensure rapid set-up during each new project. The company has in its inventory Vaisala VL-2000® temperature and humidity data loggers, VL-1000® temperature data loggers, VL-1416 low temperature data loggers, and Kaye Validator® systems. Additional equipment includes an incubator and self-contained biological indicators for verifying the effectiveness of mission-critical steam sterilization procedures. Performance Validation has developed procedures and guidelines to ensure accuracy and consistency at all project stages.  To minimize project costs, Performance Validation has a number of mapping templates that can be used for a mapping study with minimal configuration.

Flexibility is a hallmark of Performance Validation’s service model. The company provides a turn-key solution for onsite projects completion. Performance Validation project managers handle everything from strategy and equipment set-up to mapping execution and data analysis. Clients can also opt for offsite programming and data analysis – a cost-effective solution for those with in-house resources available for installing and removing mapping sensors. Finally, Performance Validation offers all of its equipment for rental when clients have the environmental mapping expertise and desire a completely in-house, DIY approach.

Significant projects from 2015 included sub-freezer and chill room qualifications, USP Controlled Rooms, validation of autoclaves, and Steam-in-Place systems. Most of Performance Validation’s work involves the pharmaceutical industry, where exacting standards and protocols are par for the course.

Performance Validation is staffed by full-time professionals with technical degrees. Project leaders are rigorously trained, and all employees participate in continuing education on best practices and emerging trends. Likewise, employees are involved in various professional organizations. Performance Validation’s internal quality system meets the ISO9001:2008 standard.

About Performance Validation, LLC

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Performance Validation has been serving the life science industries since 1988, and is a nationwide leader in providing validation, commissioning, and quality services for pharmaceutical, biotechnology, and medical device manufacturers. Every project is managed and staffed by company employees to ensure clients enjoy unrivaled peace of mind.  Let Performance Validation fill-in that missing piece of your project.

For Environmental Mapping Services Contact:

Neil Enlow
Division Manager, Performance Validation LLC
317-248-8848
Email

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.