PV Joins SCBio

For Immediate Release (Augusta, GA; May 17, 2017) Performance Validation has joined South Carolina Bio (SCBio), as an affiliate member of the organization. SCBio unites the industry’s major leaders, research institutions, and hundreds of smaller organizations and individuals in a common vision for healing, feeding, and fueling the world through life sciences. Affiliate members provide services to the life science industry.

About South Carolina Bio:
South Carolina Bio is a member-driven organization that advances South Carolina’s life science industry through collaboration, advocacy, resource support and powerful local, regional and national networks. These member organizations develop advanced medicines, vaccines, medical devices, diagnostics, equipment and bio agriculture. SCBIO members drive discovery, create therapies, relieve suffering and grow great companies.

About Performance Validation:
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.

Graduation – President of Performance Validation

For Immediate Release (Indianapolis, Indiana; May 1, 2017) Performance Validation, LLC is pleased to announce that on Saturday, April 29, 2017 Mr. Van Doel, President of Performance Validation received his Doctor of Philosophy degree from Indiana Wesleyan University in Marion, Indiana.  You will notice that Dr. Van Doel is wearing a Red, White, and Blue cord to honor his military service.  Graduation, and awarding of this degree is the cumulation of 6-years of effort.  Dr. Van Doel’s dissertation title is “Exploring Stewardship Characteristics in Professional, Scientific, and Technical Services Employee-Owned Companies”.  

The Indiana Wesleyan University’s Doctor of Philosophy with a major in Organizational Leadership is a blended program that includes both onsite and online coursework. IWU’s mission is to provide a Christ centered, innovative, and challenging doctoral program, which enables students to become accomplished in current knowledge, best practices, research, self-directed learning, and teaching.  Please join us in congratulating Dr. Van Doel on this achievement.

Regulatory Trends and Intelligence

PDA Midwest Chapter Meeting, Feb 2017 Regulatory Trends and Intelligence

(Indianapolis, Indiana, February 2017) Performance Validation will be attending and exhibiting at the PDA Midwest February 2017 Dinner Meeting. The meeting will be held on February 16, 2017 5:30 to 9 PM at the Crowne Plaza in Northbrook, IL.

The topic for the evening is Regulatory Trends and Intelligence. Regulated companies need to be aware of trends in the industry, especially ones that create 483s or warning letters. Join PDA for a dive into the recent documents and a trend analysis. The event will cover hot topics, as well as a question and answer session for audience members, Learn from other companies’ regulatory actions to prevent the same occurrence at your own. Specific topics include Sterilization, Logistics, Complaints and Deviations. The presenter is Oliver Yu, who has almost two decades of experience in Pharma industry analytics.
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 can contact Mike directly via email to schedule a meeting.

 

We hope to see you at the PDA Midwest February 2017 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.

Anaheim MD&M

Performance Validation will be attending the Anaheim MD&M Show, February 2017 in Anaheim, CA.  Maggie Scow, will be representing Performance Validation, LLC at this event.

maggieMaggie is a Senior Validation Engineer, and a Site Manager at one of our primary medical device customers.  Maggie manages our Medical Device support team who provides Verification, Validation, and Quality System Regulation support to PV’s medical device clients.  Have a question on the Quality System Regulations?  What to find out about what PV has been up to in the Medical Device space?  Maggie will be available to speak with you during the event.  Please contact Maggie directly via email to schedule a meeting!  We hope to see you at the Anaheim MD&M west show in February.

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.

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.

pv-has-you-covered

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.