Join Regulatory Compliance Associates (RCA) in Washington, DC May 15th-16th for the FDLI Annual Conference to connect with our consulting Experts to learn how we can provide you with a complete solution for any of your projects. Together we can confidentially discuss your client and can prepare compliance enforcement solutions to help ensure the safety of their products, process, and organization as a whole.
Conference Highlights:
Hear FDA’s strategic priorities directly from the FDA Commissioner and other key leaders within the agency and Health and Human Services
Join high-level colleagues in food and drug law to hear different viewpoints, shape policy, and advance understanding
Participate in over 30 sessions covering the latest in legal, regulatory, compliance, policy, marketing, and related issues to enjoy targeted for your key interests
Learn from more than 100 well-known officials and experts
Hear about the Top Cases in Food and Drug Law
Network and build relationships with seasoned legal, regulatory, compliance, policy, and government professionals
Looking forward to seeing you at the 2025 FDLI Annual Conference, the premier event for the food and drug law community! Our conference provides a unique opportunity to delve into the complex legal, regulatory, compliance, and policy issues currently impacting FDA-regulated industry. Join experts from federal government, industry, the private bar, non-profit organizations, patient and consumer advocacy groups, consulting organizations, and academia as the FDLI community meets for the event of the year!
The conference focuses on a wide spectrum of topics like Management of Outsourced Operations, Quality and Compliance Management, Innovations in cGMP Facility Design and Digitization, The Multiverse of Manufacturing Challenges, AI/ML in Pharmaceutical Quality: Advancements and Challenges, Data Governance, Management, Integrity, and Digitalization, Microbiology/Environmental Monitoring, a visit to Dendreon’s* innovative science and cellular therapy manufacturing facility, the largest plasma fractionation site in Takeda, The Los Angeles manufacturing facility visit, best practices and strategies for navigating ATMP regulatory submission etc.
The PDA Annual Meeting highlights include:
Lightning presentations
Guided poster tours
Roundtable discussions
Dynamic and current industry topics which allow you gain strategic approaches and practical solutions to help you overcome the difficult challenges in your industry and advance in your professional development.
Chance to meet with globally reputed industry expertise.
The PDA Board of Directors Co-Chair and our Distinguished Fellow, Susan Schniepp, will be helping moderate a few of the presentations during the event. She will also bring her expert perspective to the panel discussions with her 40+ years of quality consulting expertise.
RCA’s Global Head of Operations, Arie Anahory, will be co-leading and working alongside PDA in the 503B Compounding Interest Group. The group intends to bring together industry leaders involved in pharmaceutical compounding operating under Sections 503A and 503B of the FD&C Act. The group will focus on fostering collaboration and dialogue surrounding discussions on emerging regulations, best practices, and navigating the landscape of compliance. Topics covered will include production techniques, personnel practices, facility management, control of materials, and application of GMPs in daily operations ensuring quality for all drug products.
Click now to hear from Jordan Elder, RCA’s Director of Regulatory Affairs, regarding the latest info on Quality System Regulation (QSR) regulations and FDA harmonization efforts:
When developing a quality management system (QMS), it is important to understand any pitfalls that could arise as well as understand what each notified body looks for in a compliant quality system. Recently, one of the US Food and Drug Administration’s (FDA’s) top medical device regulators said harmonizing the agency’s current Quality System Regulation with the International Organization for Standardization (ISO) 13485:2016 is a “high priority”.
Click to learn about the latest updates to the QMSR File Rule.
QMS Harmonization
Currently, the US Food and Drug Administration (FDA) does not enforce ISO’s 13458:2016 standards set in place for Quality Management Systems, but uses its own Quality System Regulation (QSR) guidelines that do include parts of the 13458 standards. But this is set to change for the better. The FDA has recently proposed plans to align its quality system requirements with ISO 13485:2016, creating a new regulation dubbed the Quality Management System Regulation (QMRS). This shift came four years after the agency first proposed the regulatory alignment.
Quality Management System
Manufacturers who already conform to the ISO standard should not see much change and this move should help create efficiencies for them in the long run. The FDA proposed the alinement by incorporating the 2016 edition of the international standard specific for medical device quality management systems ISO13485. Through this rulemaking, the FDA is also proposing additional requirements that help connect and align ISO13485 with existing requirements in the FD&C Act and its implementing regulations. This will include making conforming edits to 21 CFR Part 4 to clarify the device CGMP requirements for combination products as well.
Risk Management
The most noticeable difference between the current quality systems regulation and ISO13485 is that the risk management requirements are integrated throughout the aspects of the quality management system in ISO13485. This differs from 21 CFR 820, in that the only risk-specific requirement in the QS regulation is listed in §820.30(g), as it relates to risk analysis as a part of design validation.
These revisions are intended to supplant the existing ISO13485 requirements with the specifications of an international consensus standard for medical device manufacturers. The revisions are expected to reduce device manufacturers’ burdens, specifically aspects of compliance and recordkeeping through the harmonization of domestic and international requirements.
ISO Standard
With a membership of 168 national standards bodies, ISO is an independent, non-governmental international organization that brings together experts from around the world to share knowledge and develop voluntary, consensus-based, market-relevant International Standards that support innovation and provide solutions to global challenges.
Although the standers set by ISO are recognized by organizations around the world, ISO compliance itself isn’t a legal requirement, the standards naturally align with different regulations across the industries. ISO compliance means using ISO standards as guidelines for aligning your policies, processes, and operating procedures to adhere to the standard.
ISO 13485:2016 specifies requirements for medical device quality management systems where an organization needs to demonstrate its ability to consistently meet customer and applicable regulatory requirements. This includes one or more stages of the product life cycle, including:
Design controls and development
Production and manufacturing
Storage and distribution
Installation
Servicing a medical device
Technical support
ISO13485:2016 can also be used by suppliers or external parties that provide products, including quality management system-related services to such organizations.
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.
AI management requires a risk-based regulatory framework built on robust principles, standards, and best practices. With the use of state-of-the-art regulatory science tools the risk-based framework can be applied across AI applications and be tailored to the relevant medical product. Do to the complex and dynamic processes involved in the development, deployment, use, and maintenance of AI technologies. They benefit from careful end-to-end management of AI applications throughout the product life cycle. The process starts from ideation and design and progresses through data acquisition; preparation; model development and evaluation; deployment; monitoring; and maintenance. This approach can help address ongoing model performance, risk management, and regulatory compliance of AI systems in real-world applications.
The US FDA CBER, CDER, CDRH, and OCP divisions have identified four areas of focus regarding the development and use of AI across the product life cycle to help meet the FDA GMP guidelines that are already established.
The Focus Areas
Foster Collaboration to Safeguard Public Health – Cultivate a patient-centered regulatory approach that emphasizes collaboration and health equity.
Collect input from interested parties to consider critical aspects such as transparency, governance, bias, cybersecurity, and quality assurance.
Promote the development of educational initiatives to support regulatory bodies, health care professionals, patients, and researchers to ensure safe and responsible use of AI in medical product development.
Work closely with global collaborators to promote international cooperation on standards, guidelines, and best practices to encourage global consistency.
Advance the Development of Regulatory Approaches That Support Innovation – FDA intends to develop policies that provide regulatory predictability and clarity for the use of AI.
Monitor and evaluate trends and emerging issues to detect potential knowledge gaps and opportunities in the current FDA guidelines.
Supporting efforts for evaluating AI algorithms for robustness and resilience against current FDA regulations.
Build upon existing initiatives for the evaluation and regulation of AI use in medical product development, including in manufacturing.
Issuing guidance regarding the use of AI in medical product development and in medical products.
Promote the Development of Standards, Guidelines, Best Practices, and Tools for the Medical Product Life Cycle. – Upholding safety and effectiveness standards across AI-enabled medical products. As well as building on Good Machine Learning Practice Guiding Principles.
Refine and develop considerations for evaluating the safe, responsible, and ethical use of AI in the medical product life cycle.
Identify and promote best practices for long-term safety and real-world performance monitoring.
Best practices for documenting and ensuring that data used to train and test AI models are fit for use.
Develop a framework and strategy for quality assurance of AI-enabled tools or system.
Support Research Related to the Evaluation and Monitoring of AI Performance. – To gain valuable insights into AI’s impact on medical product safety and effectiveness.
Identify projects that highlight different points where bias can be introduced in the AI development life cycle and how it can be addressed.
Support projects that consider health inequities associated with the use of AI to promote equity and ensure data representativeness, leveraging ongoing diversity, equity, and inclusion efforts.
Support the ongoing monitoring of AI tools in medical product development within demonstration projects to ensure adherence to standards and maintain performance and reliability.
CBER, CDER, CDRH and OCP plan to tailor their regulatory approaches for the use of AI in medical products to protect patients and health care workers and ensure the cybersecurity of medical products in a manner that promotes innovation.
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.
The FDA recently issued the Final Rule for the Quality Management System Regulation (QMSR) that amends the current medical device cGMP requirements of the Quality System (QS) regulation (21 CFR 820).
The FDA over the last few years has been looking to harmonize its medical device CGMP regulatory compliance and this action continues its efforts to align with other regulatory authorities to promote consistency in the regulation of devices and provide a timelier introduction of safe, effective, high-quality devices for patients.
Effective February 2, 2026, two years after the publication of the final rule, FDA will begin to enforce the QMSR requirements upon the effective date. Until then, manufacturers are required to comply with the QS regulation.
What is Changing?
Title: The new rule amends the title of the regulation. The revised part 820 will be referred to as the Quality Management System Regulation (QMSR).
Requirements: 21 CFR 820 has been amended by incorporating the International Organization for Standardization (ISO), ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes. The FDA implemented this final ruling to promote consistency in the regulation of medical devices.
Additionally, the rule establishes more requirements that clarify certain expectations and certain concepts used in ISO 13485 to mitigate inconsistencies with other applicable FDA requirements. FDA has also made conforming edits to part 4 (21 CFR part 4) to clarify the device Quality Management System (QMS) requirements for combination products. These edits do not impact the CGMP requirements for combination products.
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.
In an interview withPharmaceutical Technology®, Susan Schniepp, distinguished fellow, Regulatory Compliance Associates®, and co-chair of board of directors, Parenteral Drug Association, expands on the importance of maintaining a robust quality management system (QMS) in bio/pharmaceutical manufacturing.
For advanced therapy medicinal products (ATMPs) in particular, Schniepp emphasizes how fast-moving this sector is. “The regulations don’t keep up with the ATMPs. That technology, and their way of thinking, is turning over quicker than the regulatory standards,” she says.
“The changes in the regulations that are going to come are going to be around quality culture and maintaining a robust quality management system,” she adds. Ensuring documentation and keeping equipment calibrated are important practices to apply to these new fast-moving ATMPs, she states. Schniepp does not necessarily expect to see many changes in the regulations around ATMP development and manufacturing but thinks that there will likely be more guidance documents issued in the future, with one of FDA’s focuses being its quality management maturity model.
“There are some regulations out there that call out quality culture. In particular, the World Health Organization has one on data integrity. It has a definition and standard[s] on what quality culture is,” Schniepp says. She points out that a new aspect of her presentation at INTERPHEX this year is its interactive component, in which she sets up a scenario involving an internal audit where an incident occurs. She gives the audience three potential responses to discuss, but rather than simply asking them which response do they pick or which response is correct, she instead asks what does the chosen response say about that person or that company’s QMS and the maturity of that system?
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.
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