Browse our library of on-demand webinars.
Ever felt overwhelmed by the intricacies of computer system validation in FDA-regulated industries? Want to know the secrets behind successful CSV from an industry expert with over a decade of experience?
In this free webinar, we share clear, expert-informed guidance on successfully navigating the most common challenges in computer system validation within the FDA-regulated industries.
Presenter Rashida Ray is an experienced senior validation engineer offering a deep understanding of regulatory requirements and quality systems, underpinned by over a decade of experience in the industry.
Ever struggle with the complexities of the 510(k) submission process or know a device colleague who has? Our presenter, Trey Thorsen, MS, RAC, shares a series of best practices from his personal 510(k) playbook, offering practical insights you can apply immediately.
Ongoing travel and workplace disruptions have made in-person audits difficult if not impossible to conduct. Remote audits have emerged as a solution for avoiding canceled or deferred assurance activities.
If you're new to hosting remote audits, planning and facilitating one can be a challenge. In this free live webinar, experienced auditor and Quality/Regulatory consultant Neal Siegel will reveal practical strategies and best practices for achieving remote audit success without the headaches. He'll offer useful advice at various phases of the assessment process, including planning, document review, process review, facility review, interviews, and closing meetings.
Life science quality leaders operating in FDA-regulated industries have a lot on their plates in 2020. We recently surveyed 29 of them working inside organizations large and small to answer the critical questions: What goals are quality leaders working to achieve in 2020? Which challenges stand in their way? What are they doing to overcome these challenges and stay competitive?
In this webinar, we give you a unique look into how quality leaders are preparing for the future through the decisions they're making today. You'll come away with a clear picture of the emerging trends you can use to benchmark your own actions in 2020 and beyond.
Building a team for a gap analysis remediation project means asking critical questions. How much work is really involved? Do we have the right skillsets? Do we need to augment our staff to get this done right and on time?
Watch this free recorded webinar and learn an expert strategy for planning the resources you need to make remediation successful, along with tips for efficient implementation. We cover the areas quality departments get stuck during the planning stage, pointing out gaps that often signal resource-heavy work before presenting a strategy for resource planning, models for implementation, and more.
The FDA has stepped up inspections of manufacturing facilities producing over-the-counter (OTC) drugs and similar health products following a number of repeatedly observed current good manufacturing practice (CGMP) deficiencies. This has resulted in multiple warning letters, import alerts, and recalls.
Most of these issues demonstrate fundamental problems related to the quality management system (QMS).
Watch this free recorded webinar and learn the six key questions for assessing CGMP compliance and quality management related to the issues being observed in OTC manufacturing facilities.
The FDA Group's Larry Stevens answers over 20 user-submitted questions covering FDA compliance, quality, and regulatory topics including ISO 13485:2016, FDA guidelines regarding data integrity, MDR proactive actions, FDA inspection readiness, clinical studies, human failures & risk analysis, and more.
For years, failure to thoroughly investigate and correct problems have consistently ranked among the most commonly cited deficiencies and observations for drug and device manufacturers.
In this free webinar, we revisit the important basics as well as advanced concepts in root cause analysis and Corrective and Preventive Action (CAPA) to help you identify issues and make improvements to your organization's processes.
The release of the European Medical Devices Regulation (EU-MDR) has put significant pressure on medical device companies to closely scrutinize the new regulations, assess the impact on their own organization, and implement compliant processes and procedures accordingly.
This webinar presents a clear and concise process for structuring your transition process no matter how far along your organization is.
We present a brief overview of the basics of the EU-MDR, focusing specifically on key changes. You'll learn how to plan and scope your EU-MDR transition program, conduct a thorough gap analysis specific to EU-MDR transition, and scale your transition program to encompass the entire enterprise. We cover the key steps of implementing an EU-MDR transition program, important timeline considerations, and much more.
While many pharmacists see CGMP as having unduly risen the bar of compliance from what they have been accustomed to under SBOP, proper implementation should not be seen as a regulatory burden when compared to the costs of noncompliance––a point made clear in 2012 when improper compounding at the New England Compounding Pharmacy sparked an outbreak of fungal meningitis which resulted in 64 deaths, hundreds of injuries, and serious criminal charges.
This webinar presents a critical analysis for the importance of CGMP to the safety of compounded drugs. We present evidence based on the activity of the (FDA) in just one year (2016–2017) that adoption of some of the basic tenants of CGMP by compounding pharmacies have not been taken seriously or taken hold of as quickly as they should.
We cover the reasons why the absence of elementary practices such as the implementation of a quality management system (QMS), founded on the principal of good documentation practice (GDP), has been cited with continuous and increasing frequency, why the crux of the problem of noncompliance to CGMP is the lack of working knowledge of systems comprising CGMP regulations and a lack of basic training on those systems, and how implementation of a quality management system may accelerate the adoption of CGMP as a means of sustainability for compounded medicines in the very near future.
In 2015 and 2016, there were over 150 major medical device company acquisitions and mergers, and that trend has only accelerated in 2017. These events often bring important questions regarding quality that can have far-reaching consequences if not addressed thoroughly by both department and company leadership.
We've compiled insights from experts with firsthand experience helping device manufacturers make informed decisions when integrating quality systems and performing the due diligence necessary to ensure compliance in both the short and long term.
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 informed decisions before, during, and after absorbing a new quality system.
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.
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.
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.
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.
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.
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.
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.
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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