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White Paper The OTC Drug Manufacturer's Guide to CGMP Compliance & Quality Management

The U.S. FDA and other regulating bodies are increasingly inspecting and citing manufacturers of nonprescription drug and health products for current Good Manufacturing Practice (CGMP) violations.

Many of these deficiencies underscore widespread underlying inadequacies in implementing and maintaining a robust Quality Management System (QMS).

This guide offers manufacturers of OTC and similar health products actionable summaries and expert analyses of common CGMP compliance and QMS problems along with key questions for assessing compliance accordingly.

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White Paper Preparing for a Life Science Validation Project

Building a multi-disciplinary team to support Qualification and/or Validation of new or modified facilities, systems and processes has become a CGMP expectation of the FDA and many other regulatory agencies in ICH markets.

Carrying out these activities across all stages of a product lifecycle continues to be one of the top challenges for life science companies.

This guide will help you overcome these challenges and save valuable time locating and evaluating Validation specialists who can see your program through to success on time and on budget.

We’ve broken down the significant qualities and abilities to look for in a quality candidate and compiled them into an easy checklist. While each project brings unique needs, this guide can serve as a helpful resource for identifying the most important traits in a specialist based on the needs you face.

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White Paper Clearing Complaint Backlogs: A Guide to Efficient Complaint Management

It's not uncommon for FDA-regulated manufacturers to find themselves without the resources or processes to efficiently manage product complaints. When the resulting backlog isn’t cleared quickly and completely, the issue can compound into serious safety and compliance problems.

This guide dives deep into the common causes of complaint backlogs and offers adaptable, generalized strategies for remediation.

These scenarios and solutions were compiled by Alan Greathouse, a regulatory compliance expert with extensive experience in identifying the causes of complaint backlogs and working to develop efficient and effective ways to remediate them in companies large and small, all over the world.

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White Paper The Guide to CAPA & Root Cause Analysis in FDA-Regulated Industries

“Insufficient corrective and preventive action procedures” (CAPA) has consistently topped the list of most common FDA inspectional observations within the medical device industry since fiscal year 2010.

Its prevalence as the top problem year after year makes it clear that many device companies have issues, both known and unknown, within their CAPA programs. While the immediate compliance threats are obvious, less so are those that leave companies vulnerable to serious quality system issues that can grow and metastasize under the radar of their quality management system, putting both patients and their business at risk.

This white paper tackles CAPA from a slightly different perspective than most are used to seeing in industry publications and seminars. We’ve gathered insights from quality and compliance experts who have seen it all and fixed it all firsthand. In addition to exploring the solutions that have proven to be effective in the field, we’ll also examine one, if not the, most pivotal component of CAPA: root cause analysis.

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White Paper The Complete Guide to EU-MDR Transition

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 white paper presents key regulatory changes and a clear and concise process for structuring your transition process no matter how far along your organization is.

Inside you'll find a brief overview of the basics of the EU-MDR, focusing specifically on key changes as well as a strategy for planning and scoping your EU-MDR transition program. We cover the essentials of conducting a thorough gap analysis specific to EU-MDR transition and offer insight into how to scale your transition program to encompass the entire enterprise and the key steps of implementing an EU-MDR transition program.

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White Paper The Importance of CGMP to the Safety of Compounded Drugs

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 white paper presents a critical analysis of the importance of CGMP to the safety of compounded drugs.

This white paper offers 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 have. It also offers 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), have been cited with continuous and increasing frequency.

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White Paper Preparing for the Medical Device Single Audit Program (MDSAP)

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.

We've compiled insights from experts who have firsthand experience helping device manufacturers prepare for the MDSAP and compiled them into this handy white paper.

You'll learn the basics of the MDSAP, how the new point-based grading system works, which kinds of medical device companies stand to benefit from the MDSAP most, what to consider before pursuing MDSAP certification, and how to prepare for success before auditors arrive.

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White Paper Harmonizing Disparate Quality Systems

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.

You'll learn factors to consider when deciding whether an incoming quality system should be retained or changed, a process to follow to ensure any quality system gaps are revealed and addressed and important regulations that have a direct impact on the process. We also highlight the areas incoming quality systems are prone to noncompliance and how an experienced third-party consultant can be a valuable asset during the process.

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White Paper Ensuring Enterprise-Wide Data Integrity in FDA-Regulated Industries

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 white paper 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.

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White Paper The Complete Guide to Supplier Qualification & Quality Management

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 guide offers a step-by-step process for building better relationships with qualified suppliers and establishing a risk-based approach to supplier quality management. Inside, you'll find a summary of key regulatory requirements for supplier management, the formula for crafting an effective quality agreement and tips for working with third-party professionals when planning and running supplier audits.

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White Paper FDA Trends & Developments for the Medical Device Industry: 2016

The regulatory environment is in a state of transition. New technologies, growing cost pressures, and quickly-shifting consumer expectations are just a few of the factors driving changes in medical device manufacturing and regulatory compliance both domestic and abroad.

We've gathered the top FDA trends and developments for 2016 into this go-to guide along with advice from industry experts and on how these initiatives will affect medical device companies large and small.

We've included actionable summaries of the top ten FDA initiatives for medical device companies in 2016, key takeaways from recent FDA Guidance documents, and advice from expert consultants.

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White Paper FDA Trends & Developments for the Pharmaceutical Industry: 2016

The regulatory environment is changing fast. New technologies, growing cost pressures, and quickly-shifting consumer expectations are just a few of the factors driving changes in drug manufacturing and regulatory compliance both domestic and abroad.

We've gathered the top FDA trends and developments for 2016 into this go-to guide along with advice from industry experts and on how these initiatives will affect pharmaceutical companies large and small.

We've included actionable summaries of the top eight FDA initiatives for pharmaceuticals in 2016, key takeaways from recent FDA Guidance documents, and advice from expert consultants.

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White Paper The Emergency Guide to FDA Warning Letters & FDA 483

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 enforcement actions that may threaten your ability to produce and market products.

This guide lays out the key steps to take after receiving an FDA Warning Letter or FDA 483 including the key elements of Corrective and Preventative Action Plans (CAPA), tips from experts on crafting an effective response, and how third-party experts can help fill the gaps and assist you through the process.

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White Paper The Complete Guide to Compliance Remediation Projects

As regulations tighten on the pharmaceutical industry, compliance issues pose a major threat to manufacturers throughout every FDA-regulated industry.

When issues do arise, it’s absolutely crucial to take action with a remediation project designed to identify and remedy the root causes of the problems at hand.

Our guide to remediation lays the groundwork for an effective remediation plan aimed specifically at addressing the root causes of compliance issues.

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