Watch The FDA Group's Webinars

Preparing for the Medical Device Single Audit Program (MDSAP)

45 minute presentation, with 10 minutes Q&A.

The Medical Device Single Audit Program (MDSAP) is a global initiative designed to harmonize regulatory efforts around the world. But despite looming deadlines, comparatively few medical device companies have a meaningful understanding of the advantages (and disadvantages) of pursuing MDSAP certification and how to prepare accordingly.

This webinar offers a clear and practical guide to understanding what the MDSAP is, the kinds of device manufacturers that stand to benefit from it, what to consider before pursuing certification, and how to prepare for the audit sequence.

All registrants and attendees will receive a free white paper (PDF) covering the material discussed in the webinar.

Whether you’re a VP, Director, Regulatory Affairs Manager, Quality Assurance Professional, Consultant, or anyone else involved in ensuring regulatory compliance is maintained, you'll come away with actionable takeaways you can use to make an informed decision about the MDSAP.

Instructor Larry Stevens, RAC, has held almost every field position within FDA during his 21-year career with FDA and has over 18 years of experience in the Medical Device industry rising from an RA Manager to Vice President of RA/QA/Clinical for major class III device manufacturers.

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Ensuring Enterprise-Wide Data Integrity in FDA-Regulated Industries

45 minute presentation, with 10 minutes Q&A.

Data integrity issues are among the most significant compliance problems manufacturers struggle with today.

All too often, the scope of data integrity is misunderstood and oversimplified. Managing data and the systems that govern it stretch far beyond the IT department to encompass C-level executives and support groups in the areas of engineering, manufacturing, and quality. It requires a company-wide commitment to quality management that starts at the top.

This webinar offers a purely practical perspective on what data integrity is and how to mitigate data-related issues by developing and implementing a sound control framework. We'll also offer solutions to common data integrity problems.

Presenter Chinmoy Roy has extensive expertise in the design, delivery, and validation of industry compliant computerized and control systems for pharmaceutical and biotech manufacturing. He offers over 37 years of U.S.-based subject matter expertise in the design, development, QA, validation, and CFR 21 Part 11 implementation for automation and computerized systems. 

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Qualifying Suppliers & Managing Quality in FDA-Regulated Industries

45 minute presentation, with 10 minutes Q&A.

To the FDA, suppliers and other third party vendors are an extension of your organization,making regulatory compliance your responsibility. Outsourcing has become a global phenomenon among FDA-regulated manufacturers, making it absolutely critical to qualify new suppliers and manage quality on a routine basis.

This presentation will show you how to build better relationships with qualified suppliers and establish a risk-based approach to supplier quality management, along with other helpful tips to help you prevent supplier-related quality issues.

Whether you’re a VP, Director, Regulatory Affairs Manager, Quality Assurance Professional, Consultant, or anyone else involved in ensuring regulatory compliance is maintained, you'll come away with a clearer understanding of how to qualify suppliers and maintain quality. 

Instructor Larry Stevens, RAC, has held almost every field position within FDA during his 21-year career with FDA, and has over 18 years of experience in the Medical Device industry rising from an RA Manager to Vice President of RA/QA/Clinical for major class III device manufacturers.

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FDA Trends & Developments for the Medical Device Industry: 2016

30 minute presentation, with 10 minutes Q&A.

The medical device industry is in a state of transition. Innovation, emerging markets and growing consumer expectations around reliability, security and transparency are prompting regulatory action from the FDA.

This presentation covers key FDA initiatives medical device professionals should be aware of, including inspection trends, device security, Unique Device Identifier (UDI) implementation, and more.

Whether you’re a VP, Director, Regulatory Affairs Manager, Quality Assurance Professional, Consultant, or anyone else involved in ensuring regulatory compliance is maintained, you'll come away with a clearer understanding of industry developments in 2016.

Instructor Larry Stevens, RAC, has held almost every field position within FDA during his 21 year career with FDA, and has over 18 years of experience in the Medical Device industry rising from an RA Manager to Vice President of RA/QA/Clinical for major class III device manufacturers.

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FDA Trends & Developments for the Pharmaceutical Industry: 2016

30 minute presentation, with 10 minutes Q&A.

The pharmaceutical industry is changing fast. Innovation, emerging markets and growing consumer expectations around reliability, security and transparency are prompting regulatory action from the FDA.

This presentation covers key FDA initiatives pharmaceutical professionals should be aware of, including continuous manufacturing, inspection scheduling, cGMP compliance, and more. 

Whether you’re a VP, Director, Regulatory Affairs Manager, Quality Assurance Professional, Consultant, or anyone else involved in ensuring regulatory compliance is maintained, you'll come away with a clearer understanding of industry developments in 2016.

Instructor Larry Stevens, RAC, has held almost every field position within FDA during his 21-year career with FDA, and has over 18 years of experience in the Medical Device industry rising from an RA Manager to Vice President of RA/QA/Clinical for major class III device manufacturers.

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Recovery From Warning Letters & FDA 483

45 minute presentation, with 15 minutes Q&A.

Receiving an FDA Warning Letter or Form 483 requires companies take immediate action to resolve issues and communicate those fixes to regulators within 15 business days. Failing to respond or submitting an inadequate response can lead to severe enforcement actions that may threaten your ability to produce and market products.

This presentation will cover the essential steps of Warning Letter and FDA Form 483 recovery including CAPA, writing and submitting your response, and next steps.

Whether you’re a VP, Director, Regulatory Affairs Manager, Quality Assurance Professional, Consultant, or anyone else involved in ensuring regulatory compliance is maintained, you'll come away with actionable takeaways you can apply to your quality processes now.

Instructor Larry Stevens, RAC, has held almost every field position within FDA during his 21-year career with FDA, and has over 18 years of experience in the Medical Device industry rising from an RA Manager to Vice President of RA/QA/Clinical for major class III device manufacturers.

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The Complete Guide to Compliance Remediation Projects

45 minute presentation, with 15 minutes Q&A.

As the regulatory environment tightens, compliance has never been more important or more difficult.

This presentation will cover everything you need to know to identify the root causes of compliance issues and craft effective remediation projects to address them. 

Whether you’re a VP, Director, Regulatory Affairs Manager, Quality Assurance Professional, Consultant, or anyone else involved in ensuring regulatory compliance is maintained, you'll come away with actionable takeaways you can apply to your quality processes now. 

Instructor Larry Stevens, RAC, has held almost every field position within FDA during his 21 year career with FDA, and has over 18 years of experience in the Medical Device industry rising from an RA Manager to Vice President of RA/QA/Clinical for major class III device manufacturers.

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Laboratory Developed Tests: Issues and Anticipated Regulations

45 minute presentation, with 15 minutes Q&A.

On July 31, 2014 the FDA notified Congress of the Agency’s intent to issue a draft oversight framework for Laboratory Developed Tests (LDTs) based on risk on patients. This is a change from the current framework where regulatory oversight is determined based on whether the LDT is made by a conventional manufacturer or a single laboratory. FDA released the draft guidances describing the regulatory oversight for LDTs, which uses a risk-based approach and will be implemented over the course of multiple years.

Your instructor, Larry Stevens, RAC, has held almost every field position within FDA during his 21 year career with FDA, as Investigator, Supervisory Investigator, Compliance Officer, Director of Import Operations, Acting Director of Compliance and Acting District Director. He also has over 18 years of experience in the Medical Device industry rising from an RA Manager to Vice President of RA/QA/Clinical for major class III device manufacturers.

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Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval

45 minute presentation, with 15 minutes Q&A.

On April 13, 2015 FDA issued a Final Guidance Document titled, Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval. The purpose of this guidance is to clarify FDA’s stance on balancing premarket and postmarket data collection during review of Premarket Approval Applications (PMAs). This Guidance presents important insight for manufacturers with devices subject to PMA requirements. It includes details on both the benefits of using postmarket data and when postmarket data is appropriate, from an FDA perspective. Leveraging postmarket data will result in decreased time to market and ensure continued surveillance of the safety of medical devices; therefore, industry is encouraged to work with the agency to better understand the balance between pre and postmarket data. If used correctly, the program might allow quicker approvals of PMA’s.

Your instructor, Larry Stevens, RAC, has held almost every field position within FDA during his 21 year career with FDA, as Investigator, Supervisory Investigator, Compliance Officer, Director of Import Operations, Acting Director of Compliance and Acting District Director. He also has over 18 years of experience in the Medical Device industry rising from an RA Manager to Vice President of RA/QA/Clinical for major class III device manufacturers.

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New Regulations on Unique Device Identification

45 minute presentation, with 15 minutes Q&A.

On September 24, 2013, FDA issued a final rule on the Unique Device Identification (UDI) requirements for medical device manufacturers who market products in the US. While the regulation will require companies to implement many changes to current labeling, packaging, and quality system procedures, if strategically planned, a UDI implementation effort can result in improved product identification and tracking. Medical device manufacturers should fully understand the latest UDI regulations to facilitate the deployment of a compliant, cost-effective, and efficient UDI program.

Your instructor, Larry Stevens, RAC, has held almost every field position within FDA during his 21 year career with FDA, as Investigator, Supervisory Investigator, Compliance Officer, Director of Import Operations, Acting Director of Compliance and Acting District Director. He also has over 18 years of experience in the Medical Device industry rising from an RA Manager to Vice President of RA/QA/Clinical for major class III device manufacturers.

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Successfully Submitting a 505(b)(2) Application

The 505(b)(2) is a New Drug Application (NDA) mechanism which allows an applicant to seek approval for a drug product based on full safety and efficacy documentation, some of which may be from literature or conducted by others and for which the applicant does not have the right of reference.

Created in 1984, it is a streamlined process and does not require the applicant to conduct all the required studies or obtain a right of reference. A 505(b)(2) can been used to get approvals for changes such as New Delivery Mechanisms, New Dosage Forms, New Formulations and New Indications.

It has the advantage over the traditional process by being able to rely on previously published material, and so can be quicker as well as being lower cost.

In this webinar, we will discuss how to successfully use the 505(b)(2) mechanism.

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Compliance Remediation Projects

Compliance with today’s regulations has never been more important. The regulations by the Food and Drug Administration (FDA) have become more stringent over the past fifteen years, and the penalties for not complying with the regulations have become more severe. At minimum, these can include issuing warning letters, untitled letters, consent decrees, or other such documents. The FDA may require a manufacturer to shut down production of a pharmaceutical or device, which can lead to lost revenues. More severe legal actions can include enforcing the Racketeer Influenced and Corrupt Organizations law.

Violations can occur even in the most compliant companies. As such, many manufacturers may be in need of remedial procedures correct these violations. Therefore, it is important for pharmaceutical executives to understand the processes associated with compliance remediation.

In this webinar, we will discuss how to stay compliant and deal with non-compliant projects.

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Effective Responses to FDA Warning Letters on Quality Systems

The FDA has increasingly turned to Warning Letters as a tool for voluntary compliance. Unfortunately, the types of issues FDA is including in Warning Letters makes mere compliance not sufficient, but rather state of the art quality systems. It is no longer sufficient to simply have a procedure and follow it. FDA may consider the procedure inadequate and the evidence you follow the procedure may not be acceptable to FDA as you may have not have performed it to the FDA requirements.

In this webinar, we will discuss the kinds of issues FDA tents to cite in Warning Letters relating to quality system deficiencies. We will discuss inadequate responses and the FDA consequences for such. We will discuss how to prepare a response that FDA will consider acceptable.

Your instructor, Larry Stevens, RAC, has held almost every field position within FDA during his 21 year career with FDA, as Investigator, Supervisory Investigator, Compliance Officer, Director of Import Operations, Acting Director of Compliance and Acting District Director. He also has over 18 years of experience in the Medical Device industry rising from an RA Manager to Vice President of RA/QA/Clinical for major class III device manufacturers.

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