Community Outreach – Kalamazoo

Kalamazoo, January 30, 2017 – The 2017 Corporate Engineering Challenge will be once again be held at the Kalamazoo Air Zoo hosted by the Air Zoo and the Society of Women Engineers, South Central Michigan Section.  The event will run from 9AM to 3PM on Saturday February 18th.

Young, aspiring male and female engineers will have the opportunity to visit multiple stations at the Air Zoo and complete engaging, “hands-on” engineering and science activities provided by local corporate sponsors.

Girls aged 9-12 will have the opportunity to team up with practicing female engineers and compete in an engineering challenge! Challenge teams will be associated with one of the event sponsoring companies, each having a history of innovation and advancement in the engineering field.  Don’t miss out! This is a great opportunity for interaction between young women interested in engineering and successful female engineers in a variety of industries.

Additional details about the event, and a registration link is available here.

Performance Validation, LLC is pleased to be a sponsor of this event, providing community outreach – Kalamazoo,  and several of our female engineers will be in attendance.

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

Jan 2017 PDA Midwest Chapter Meeting

Performance Validation will be attending and exhibiting at the Jan 2017 PDA Midwest Chapter Meeting.  The meeting will be held on January 26, 2017 5:30 to 9 PM at the Crowne Plaza in Northbrook, IL.

The topic for the evening is the DuPont™ Tyvek® Case Study:

Manufacture of complex pharmaceuticals requires understanding and mitigation of risk. For biopharmaceuticals or for products that cannot be terminally sterilized, risk to the final product is minimized through control of bioburden or full aseptic processing. In cleanroom environments where this type of processing takes place, a potential source of contamination is particle shedding from human workers. A mechanism to minimize risk from this contamination is through use of appropriate cleanroom protective garments. In aseptic processing areas or in bioburden control areas, these garments are typically sterile. There are many methods used to sterilize garments—all of these methods not only kill micro‐organisms, but can impact the polymers that make up the garments. To better understand the impact of sterilization, this presentation will address common polymer degradation mechanisms. As an example of the impact of sterilization on garments, a case study of evaluation of reusable, woven polyester, cleanroom garment properties as a function of gamma radiation exposure dose will be presented. This can be contrasted against the change in functionality for single‐use garments after radiation exposure. Data showing the impact of radiation on the polymers making up the garments via molecular weight analysis will also be presented. With the physical property information, implications for particulate load in a cleanroom can be considered, and ultimately drive a better understanding of garment properties over their expected service life.

Mike Stires

Mike 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 may contact Mike directly via email to schedule a meeting.

We hope to see you at the Jan 2017 PDA Midwest Chapter 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.

 

 

Jason LaBella – Certified Quality Auditor

For Immediate Release (Indianapolis, Indiana; January 10, 2017).  Performance Validation is pleased to announce that Mr. Jason LaBella 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.

Fall 2016 PSDG Meeting

The PSDG Fall Meeting for 2016 will be held October 2, from 3 to 9 PM at the Renaissance Chicago North Shore Hotel in Chicago, IL.

Mike S

Mike Stires will be Performance Validation’s primary point of contact at this event.

 

Mike is a Principal Validation Engineer and is the Site Manager for PV’s Illinois office. His team supports work primarily in Illinois and Wisconsin.

 

Performance Validation has significant experience in performing temperature mapping of stability chambers.  Please see our Environmental (Temperature/Humidity) Mapping services page for details on our capability.  Additionally, we have posted a number of project summaries that detail support we have provided our customers.  Feel free to ask Mike how Performance Validation may help you meet your project needs.

The purpose of the meeting is to share information on a broad range of stability topics over the entire course of the meeting, so the quality and success of the meeting rely on a commitment to avoid filling the seats with those who are “there to learn” as opposed to those who are “there to share.”

The presentation portion of the PSDG meeting is a complimentary 2-hour mini-course provided on Sunday from 3:00 – 5:00pm by PSDG vendors or participants regarding focus-topics associated with the stability function.  It includes presentations, followed by a panel discussion with the audience for Q&A.  The Fall 2016 topic is:  Stability Studies for Non-Labeled Conditions (Hold Times, Out of Refrigeration, Shipping, etc.)

Following the presentation portion of the meeting, there will be a reception, vendor exhibits, and a dinner.

Pharmaceutical Stability Discussion Group is the name of this meeting, which is being organized through Pharmaceutical Discussion Groups, a not for profit, volunteer-powered, professional affinity association.

We hope to see you there!

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