How do you ensure that your pharmaceutical product is tested correctly to get it to market as quickly and safely as possible? You can learn directly from our industry experts in Philadelphia on May 11th and 12th.

Join us for two days full of information and discussion about sterilization and lab testing, from both a microbiological and analytical chemistry perspective, presented by experts from Nelson LabsPDA Expert Advisors, Regulatory Compliance Associates® Inc. (RCA), and Sterigenics.

You can expect to gain a good understanding of the principles of end-to-end sterility assurance, including terminal sterilization and aseptic processing. You will also gain valuable regulatory insights. Additionally, you will learn about the use of various sterilization technologies that are suitable for pharmaceutical products and about extractable and leachable testing for single-use systems (including bioprocessing equipment and pharmaceutical manufacturing) and small-volume parenterals. We’ll wrap up the training by discussing requirements for container-closure-integrity testing, release testing, and stability testing.

The industry experts who will be presenting will cover the following topics:

  • End-to-end sterilization & lab-testing solutions
  • Regulatory agencies’ views on terminal sterilization & aseptic processing
  • Sterilization gas & radiation modalities
  • Sterilization programs
  • Aseptic processing compared to terminal sterilization
  • Aseptic processing’s associated challenges
  • E&L considerations for pharma
    Steven J. Lynn
    Steven J. Lynn
  • E&L for bioprocessing equipment & single-use systems
  • E&L for small-volume parenteral applications
  • Container-closure-integrity testing
  • Phase-appropriate method validation
  • Release & stability testing requirements for parenteral drug products

Steven J. Lynn, MS, RCA’s Executive Vice President of Pharmaceuticals, will be presenting on the Regulatory Agencies’ View on Terminal Sterilization & Aseptic Processing on Wednesday at 9:30 am. 


Use the blue Contact Us form at the bottom of the page to schedule a meeting with Steven Lynn!


Registration deadline is April 29, 2022

About RCA

Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

About Nelson Labs

Every year, hundreds of medical device, pharmaceutical, and tissue companies make Nelson Labs their testing laboratory of choice. For them, the decision is easy. Nelson Labs is a clear leader in the microbiology and analytical chemistry testing industry, offering more than 800 laboratory tests and employing more than 500 scientists and staff in state-of-the-art facilities. We are known for exceptional quality and rigorous testing standards, but it is our focus on the bigger picture that sets us apart. We look beyond test results and partner with you to achieve your long-term business goals — mitigating risk, being first to market, and succeeding with your customers.

Companies choose Nelson Labs for:

  • Thought leaders and approachable experts. We give you direct access to industry authorities who understand your business and add value every step of the way.
  • Customer-centric culture. We take the time to understand your vision. Your goals become our goals.
  • Real-time project management tools and a dedicated client portal. We provide proactive information, keeping you informed and in control.
  • Metric-driven testing processes. We’re our own toughest customer, holding ourselves to goals exceeding 99% for things that matter most to you, like quality, turnaround time, and testing accuracy.
  • Global compliance expertise and support. We act as a trusted advisor, helping you navigate the ever-changing compliance landscape.

See how we can help you mitigate risk, be first to market, and succeed with your customers.

About Sterigenics

Sterigenics is a leading global provider of outsourced terminal sterilization services for the medical device, pharmaceutical, food safety and advanced applications markets. Across our 48 global facilities, we offer our customers a complete range of sterilization services, primarily using the three major technologies: gamma irradiation, ethylene oxide processing and electron beam irradiation as well as nitrogen dioxide sterilization and x-ray irradiation. We are committed to addressing the growing need for sterilization across the world and partnering with our customers to eliminate threats to human health. Learn more about Sterigenics at www.sterigenics.com

 

To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

pda annual meetingJoin Regulatory Compliance Associates® Inc. (RCA) and Nelson Labs at Booth 307 and 309 during the 2022 PDA Annual Meeting in Dallas this year. The conference will focus on the theme “Level Up: Agility in the New Normal!” and will highlight what’s in store for the future of pharmaceutical manufacturing. Examine how companies are developing new modalities and adapting to the current manufacturing environment through the modernization of aging facilities and the adoption of innovative approaches and processes.

There are interactive sessions and tracks designed for manufacturing leaders, technical experts/scientists, and early career professionals. No matter what your area of focus, you are sure to come away with tangible, practical solutions to improve your operations and your standing within your company.

 

Steven J. Lynn

Steven Lynn, MS, RCA’s Executive Vice President of Pharmaceuticals, will be presenting in the Quality and Regulatory Track at 10:45 AM-12:15 PM on Wednesday. The presentation titled: Analyzing global FDA 483 Observation trends (2018-2020) will discuss (1) which sub-groups received the greatest number of violations, and (2) present data-driven best practices to trade show attendees for proactively reducing the potential for violations.

 


Use the blue Contact Us form at the bottom of the page to schedule a meeting with Sue or Steve!


“The year over year data trends seem to continually repeat. Like the movie Groundhog Day, the same thing over and over and over. What can we do as an industry to get better and make meaningful change.”

– Steven J. Lynn

 

Susan Schniepp

The PDA Board of Directors Chair and our Distinguished Fellow, Susan Schniepp, will be kicking off the event during the welcome event. She will also bring her expert perspective to the panel discussions with her 40+ years of quality consulting expertise.

 

2022 PDA Annual Meeting Exhibit Hours

Monday, April 4th, 2022 | 5:00PM to 6:30PM

Tuesday, April 5th, 2022 | 9:45AM to 4:00PM

Wednesday, April 6th, 2022 | 9:45AM to 1:45PM

 

To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

Regulatory Compliance Associates® Inc. is pleased to announce that our distinguished fellow, Susan Schniepp, has been elected as the Parental Drug Association (PDA) Board of Directors Chair for 2022.

 

The PDA is a recognized authoritative voice and leading technical organization in the field of parenteral science and technology. Through the development of Technical Reports and responses to regulatory initiatives, PDA and its members influence the future course of pharmaceutical products technology.

 

Parental Drug Association

As Chair, Susan will help ensure that the board of directors is effective in its task of setting and implementing the Parental Drug Association direction and strategy and she will provide leadership to the other officers and executives. She was voted in and will begin her duties as the Chair at the start of 2022.

 

We are looking forward to seeing how her influence at the PDA will help advance the industry in 2022.

 

About RCA

Regulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

Check out the interview Vice News did with our Executive VP of Pharmaceuticals, Steven Lynn, on how the Covid-19 pandemic is revealing major holes in the pharmaceutical supply chain.

 

About Steve Lynn

Supply ChainSteve has over twenty (20) years of quality and regulatory compliance-related experience in the pharmaceutical, biopharmaceutical, medical device, blood, plasma, and tissue industries. He is an expert in Current Good Manufacturing Practices (CGMP) compliance-related matters and has significant experience with other GxP quality compliance and regulatory issues.

Joining Regulatory Compliance Associates® Inc. in September of 2020, Steve serves as RCA’s Executive Vice President of Pharmaceuticals.

Prior to joining RCA, Steve served in executive leadership roles with global accountability in both the private sector, as well as at the US FDA. In the private sector, Steve was an executive at two large multi-national corporations and also worked as a compliance and supply chain consultant. He was the Global Head of Group (Corporate) Compliance and Audit for Novartis AG. In this role he led the corporate-level GxP corporate compliance and audit functions across the company.

Next, Steve was the inaugural Vice President of Global Quality Compliance for Mylan, Inc. a large generics manufacturer. Prior to rejoining the private sector, Steve worked for nearly a decade at the FDA. At the FDA, was the Director of the FDA/Center for Drug Evaluation and Research’s (CDER) Office of Manufacturing and Product Quality (OMPQ) within the Office of Compliance (OC). In this role, he was responsible for the global Current Good Manufacturing Practices (CGMP) oversight of all drugs manufactured and/or imported into the United States to assure compliance with CGMPs.

In addition, in his last year at the FDA, he served in a dual position as the Operations Transition Lead for CDER’s new Office of Pharmaceutical Quality (OPQ) reporting to CDER’s Center Director where he was responsible for setting up OPQ operations.

Steve also served in two acting roles on the inspectorate side of FDA within the Office of Regulatory Affairs (ORA). First, he served as the acting Senior Advisor to the Assistant Commissioner for Operations (ACO) within the Immediate Office of ORA’s Office of Operations. In this role, Steve was responsible for advising the ACO in their role of leading and managing ORA’s Office of Operations, which is responsible for all of the Agency’s Headquarters, Domestic and Foreign Field Investigatory, Compliance, and Laboratory Operations.

Second, Steve served as the acting Director for ORA’s Office of Medical Products and Tobacco Operations (OMPTO). In this role, Steve represented and made decisions on behalf of the ACO relating to medical and tobacco product program investigatory operational issues, including emergency response activities and supply chain. In addition, he directed the coordination and management of all domestic and foreign Agency field operations related to medical (drugs, biologics, and medical devices) and tobacco products. Additionally, Steve served as the operational liaison for medical products and tobacco inspection programs to FDA’s medical product and tobacco Centers, as well as to the Agency’s foreign offices.

Steve received a Bachelor of Science degree in Biology from Bethany College in Bethany, WV, and a Master of Science Degree in Quality Systems Management from the National Graduate School in Falmouth, MA. He is an Eagle Scout, Senior Member of the American Society for Quality (ASQ), and an Excellence in Government Program Senior Fellow.

 

About RCA

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

 

To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

Pleasant Prairie, WI (Sept 22, 2020) – Regulatory Compliance Associates® Inc. (RCA), a life sciences consultancy focused on quality, regulatory, and technical consulting, announces Steven Lynn has accepted the position of Executive Vice President of Pharmaceuticals.

 

Mr. Lynn brings more than  20 years of global, real-world experience in the private sector and U.S. federal government, including two U.S. Food and Drug Administration product Centers (the Center for Drug Evaluation and Research and the Center for Devices and Radiological Health), as well as FDA’s inspectorate (the Office of Regulatory Affairs).  “RCA clients will benefit from Steve’s expertise with FDA’s insights regarding compliance and regulatory framework and will help them navigate regulatory challenges in the medical product and biologics sectors,” says Erika Porcelli, CEO of RCA.

 

In addition to his FDA experience, Steve gained valuable real-world, private sector experience in global manufacturing and quality for generics and brand pharmaceuticals, as well as in the medical device industry. Prior to joining RCA, Steve held executive roles with leading brand and generic pharmaceutical and biopharma manufacturers, the FDA, and in private consulting in the areas of pre and post-market (GxP) quality, compliance, and regulatory affairs.  “His extensive background spanning industry, consulting and the FDA gives Mr. Lynn a unique perspective in providing RCA clients with wholistic and seasoned guidance as they bring new life-sustaining medicines to the market, as well as maintaining compliance with FDA and other global health authorities quality oversight,” adds Porcelli.

 

Accomplished in leadership and quality management, Steve earned a Master of Science degree in Quality Systems Management from the National Graduate School of Quality Management (NGS), is a Senior Fellow in Study Excellence in the Excellence in Government Leadership Program, and has a Bachelor of Science degree in Biology.  Mr. Lynn also served the non-profit Parenteral Drug Association (PDA) as the Secretary of the Board.

 

About RCA

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

 

To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

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