Optimizing Your Quality Management Program 

This FDA News virtual summit will empower you to develop a world-class QMS by implementing the essentials of quality management maturity (QMM) metrics, something the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) are pushing. As well as, detail on how to ensure your quality culture is a high-powered functional tool. Sessions will clearly demonstrate the importance of quality culture to standardize efficient behaviors via meaningful metrics.

You’ll come away with the knowledge and know-how to create a world-class QMS:

• What the FDA looks for in a QMS
• How to ensure your continuous improvement initiative addresses GMP and other regulatory requirements, including the FDA’s expectations resulting from the COVID-19 experience
• How to ensure your drug or device meets the quality expectation of consumers
• The importance of creating quality milestones and incentives that are patient-focused and transparent to give you a demonstrable advantage over your competitors and credibility with the FDA
• How to develop QMM metrics that go beyond mere numbers and actually measure quality
• The importance of quality culture as a tool to standardize efficient behaviors via meaningful metrics
• How to meet supply chain challenges and evaluate vendors to ensure quality service
• The intersection of data integrity, risk management, and quality management
• Establishing a culture of quality throughout your organization

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

RCA Speakers

The PDA Board of Directors Chair and our Distinguished Fellow, Susan Schniepp, will be the Summit Chairperson who will be leading the summit. Sue is the knowledge leader responsible for training and advising RCA staff and clients on current trends and issues facing the pharmaceutical, biotechnology, and medical device industries. Her background includes cGMPs, audit readiness, change control, investigations, supplier quality, and batch record reviews.

Ms. Schniepp has more than 40 years’ experience in quality assurance, serving in leadership roles at Allergy Laboratories, OsoBioPharmaceuticals, Searle, Abbott, and Hospira. In addition, she served on the Parenteral Drug Association Board of Directors from 2011-2013 and 2016-2019 and currently serves as the Board Chair.

Steven Lynn, MS, RCA’s Executive Pharmaceutical Consultant, has more than 20 years of quality and regulatory compliance-related experience in the pharmaceutical, biopharmaceutical, medical device, blood, plasma, and tissue industries.

Joining RCA in September 2020, Steven serves as executive vice president of pharmaceuticals. Prior to joining RCA, he served in executive leadership roles with global accountability in the private sector as well as at the FDA. While at the agency, he was the director of CDER’s Office of Manufacturing and Product Quality. In this role, he was responsible for the global oversight of all drugs manufactured and/or imported into the U.S. In addition, in his last year at the FDA, he also served as the operations transition lead for CDER’s new Office of Pharmaceutical Quality.

Seyed Khorashahi, Executive Vice President of Medical Device and CTO, has more than 25 years of experience leading research and development teams in all aspects of creating safety-critical medical devices. He has held leadership positions at Covidien (Medtronic), Baxter, and Beckman Coulter, Inc. and he has an extensive background in medical device product development, quality systems, regulatory affairs, mergers and acquisitions, engineering, and business strategy.

He returned to Regulatory Compliance Associates (RCA) in 2015 as COO and now works in conjunction with the CEO and Board of Directors to define operational and technical strategy, as well as plan and develop the primary processes to support client service delivery.

About RCA’s Pharmaceutical Consulting Services 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates^® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 

Client Solutions

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process. Our pharmaceutical consulting Experts will create a customized approach depending on your product and company’s individual needs. Our regulatory compliance clients include:

• Companies new to FDA, Health Canada or EU regulations and regulatory compliance
• Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
• Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
• Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

Regulatory Affairs

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs. Additionally, we specialize in Regulatory Support for New Products to Life Cycle Management, Outsourced Regulatory Affairs, Submissions, Training, and more.

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

• New Product Support
• Product Lifecycle
• Other Regulatory Services
• Combination Products

Compliance Assurance

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

• Assessments
• Audits
• Regulatory Agency Response
• Preparation and Training
• Inspection Readiness
• Data Integrity

Quality Assurance

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality. Finally, our regulatory compliance services team excels in transferring continuous improvement knowledge to your organization.

• 21 CFR Part 11
• Data Integrity
• Manufacturing Support
• Facility Support
• Quality Metrics

Remediation Services 

Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

• Regulatory Action
• Regulatory Compliance
• Regulatory Enforcement
• Warning Letter
• 483 Observation
• Oversight Services
• Risk Management Plan

About Regulatory Compliance Associates

Regulatory Compliance Associates^® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

• Life Sciences
• Pharmaceutical
• Biologic & Biotechnology
• Sterile compounding
• Medical device
• Lab Testing

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, Health Canada, MHRA and globally-regulated companies.

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

• Founded in 2000
• Headquartered in Wisconsin (USA)
• Expertise backed by over 500 industry subject matter experts
• Acquired by Sotera Health in 2021

About Sotera Health

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health^®.

Sotera Health Company, along with its three best-in-class businesses – Sterigenics^®, Nordion^® and Nelson Labs^®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

Commitment to Quality

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

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