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Data Integrity In-Person Training Course

Posted on by Brandon Miller

Regulatory Compliance Associates’ (RCA) Susan Schniepp, Distinguished Fellow at RCA and Chair of the Board of Directors at the Prenatal Drug Association (PDA) leads this training in collaboration with the FDA through the Compounding Quality Center of Excellence and the PDA.

This course was also offered on February 25-26, 2025 in Durham, NC.

Course Description

In this two-day course, key concepts to consider when designing processes that collect and utilize data and associated metadata will be discussed. The overall goal is to ensure data is complete, consistent, and accurate through consideration and control of sources of variability stemming from hardware, software, personnel and documentation. Processes that are well designed from the beginning, reduce the risk that a critical decision is made using unreliable data.

This course combines lecture, discussion, small group breakout exercises, and case studies to evaluate the current regulatory expectations and best practices for data integrity, with an overall focus on safety of the patient through good scientific process design principles. This course is targeted for regulators and personnel working in outsourcing facilities (503B) who collect, review, manage or utilize data and/or metadata.

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Learning Objectives

Upon completion of this training course, the attendee will be able to:

  1. Understand the regulatory expectations for data integrity and current FDA thinking on the topic through the FDA Guidance for Data Integrity to enhance further understanding in establishing a robust data integrity program
  2. Describe and understand basic requirements for data integrity and the risks associated with poor data integrity processes and improper or poorly trained staff
  3. Understand critical requirements for a robust data integrity program
  4. Understand the pros and cons of paper, electronic, and hybrid data integrity programs
  5. Understand the importance of training and qualification of personnel in managing data integrity

 

 

 

PDA Annual 2025

Posted on by Brandon Miller

Join Regulatory Compliance Associates® Inc. (RCA) at booth #517 during the PDA Annual Meeting in Palm Springs, California, April 6 – 11, 2025. The event will be held at the Palm Springs Convention Centre.

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.

 

 

Susan Schniepp

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. 

 

 

Strategic Consulting Services

Posted on by Brandon Miller

About RCA’s Strategic Consulting Services

Whether it’s a corporate needs analysis, corporate growth/transformation initiative or due diligence/acquisition, Regulatory Compliance Associates (RCA®) worldwide experience can help ensure a successful mix of top-notch advice and people so your strategy is on time, and on budget — and you’re never embroiled in a costly mistake.

 

Follow the links below to learn more about our strategic consulting services in Pharmaceuticals and Medical Devices. 

 

Pharmaceuticals

Medical Device

 

 

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. You may also email us at [email protected].

Remediation Consulting Services

Posted on by Brandon Miller

About RCA’s Remediation Services

Regulatory Compliance Associates has significant quality and regulatory compliance consulting experience and a proven regulatory framework for managing FDA  483’s, Warning Letters, and Consent Decrees. Our pharmaceutical consultants know how to partner with executive, legal, and communication teams at all levels of a life science company. RCA’s remediation consulting experts can assist your management with a remediation strategy that is accepted by the regulatory agency and realistic to execute internally.  Finally, RCA can partner with your leadership team to develop a long-term risk management plan to help your team stay in compliance going forward.

 

Regulatory Compliance Associates can assist with answering FDA 483 observations, FDA Warning Letters and developing strategies to help your organization maintain regulatory compliance through continuous improvement.

 

RCA can help with remediation activities in both manufacturing operations & quality management systems.  RCA’s regulatory consultants have completed many projects assisting our clients to evaluate what is needed, collaboratively determine action plans & help execute.  We have also performed post-implementation audits to ensure regulatory compliance.

 

Follow the links below to learn more about our remediation services in Pharmaceuticals and Medical Devices. 

 

Pharmaceuticals

Medical Device

 

 

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. You may also email us at [email protected].

Compliance Consulting Services

Posted on by Brandon Miller

About RCA’s Compliance Assurance Services

Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit or developing a response to an FDA finding, Regulatory Compliance Associates® team of compliance consultants can help. Our business consultant Experts are internationally known in the regulatory compliance consulting industry.

 

The regulations process surrounding life science companies can be tricky for even the most experienced compliance veteran. If you’re consistently unable to comply with regulations, any notified body can deliver devastating consequences for your business. At RCA®, we offer the management consulting resources necessary to guide you in regulatory compliance.

 

Follow the links below to learn more about our compliance assurance services in Pharmaceuticals and Medical Devices. 

 

Pharmaceuticals

Medical Device

 

 

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. You may also email us at [email protected].

FDA Guidance on Postmarket updates to AI-enabled devices

Posted on by Brandon Miller

What is a pre-determined change control plan (PCCP)?

The FDA recently released a final guidance on regulating AI-enabled medical devices that focuses on how manufacturers can modify these devices after they are authorized. The agency introduced a new regulatory framework called pre-determined change control plans (PCCPs), which allows certain post-market changes to devices using AI or machine learning. PCCPs were first mentioned in a 2019 discussion paper, and the FDA has since issued draft and final guidance on them.

 

PCCP Required Information

This final guidance outlines the required information for PCCPs, which includes;

  • Description of Modifications – The specifications for the characteristics and performance of the planned modifications to the device;
  • Modification Protocol – The associated verification and validation testing activities that will support the planned modifications and acceptance criteria to assure the device remains safe and effective across the intended use populations
  • Impact Assessment – The assessment of the benefits and risks of implementing a PCCP, as well as the plan for risk mitigation.

Need help establishing a PCCP for your medical device?

Contact Us Now!

Manufacturers can propose updates to AI models, such as re-training to improve accuracy, without needing new submissions, as long as the changes stay within the device’s intended use. However, significant modifications outside the scope of the PCCP, like altering a device’s function or user base, would require new FDA submissions.

 

How do you establish a pre-determined change control plans (PCCPs) for my medical device?

Premarket authorization for AI-enabled devices with a PCCP must be established through the PMA pathway, 510(k) pathway, or De Novo pathway as a PCCP must be reviewed and established as part of a marketing authorization.

 

Follow the link to learn more about RCA’s Medical Device Product Approval Support and Submission Services.

 

 

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. You may also email us at [email protected].