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Instructor : John E Lincoln
Product Id : 30379PACK

Overview: This webinar will examine both the FDA and MDD regulatory expectations for the respective DHF and TF / DD. It will discuss the major sections of both, common elements and differences, what must be included and what should be included, and how the information should be compiled and presented.

Major modules of a DHF SOP and a TF / DD SOP will be presented and discussed - the webinar will address the development of a new, or revision of an existing DHF SOP and TF / DD to ensure they meet regulatory expectations and assist those charged with compiling, updating and/or revising these mandatory documents.C15

Why should you attend: The U.S. FDA implemented Design Control requirements in 1996/97, and yet continues to find problems in the key design control document, the Design History File (DHF). Yet this drives the Device Master Record as well as providing major support for the EU MDD's Technical File / Design Dossier. What are the FDA expectations for the DHF under Design Control? What are the EU MDD / Notified Body's expectations for the complementary TF / DD? How are they similar? What are the important differences? In what ways are they moving together under Harmonization? Evaluate some of the key inputs to both, which should form the basis for SOP's explaining the development of each.

Areas Covered in the Session:
  • Design Control and the DHF
  • The 9 Key Elements in the DHF
  • The DHF/DMR and the MDD's TF / DD
  • The 13 Key Elements of the TF / DD
  • Differences and Similarities
  • High Risk Areas
  • Movements Toward Harmonization
  • Incorporating These Points Into a Design Control / DHF SOP and a TF / DD SOP

Who Will Benefit:
  • Senior management primarily in Devices; some value to Drugs, Biologics, Dietary Supplements
  • QA
  • RA
  • R&D
  • Engineering
  • Production
  • Operations


Instructor : John E Lincoln
Product Id : 30379PACK

Overview: There is a continuing pervasive public perception that the FDA has been ineffective in protecting the public. Recent news events in foods, drugs, and devices seem to support this perception. The "tougher" FDA is determined to change that perception. Industry must be prepared to adapt, and recognize that such adaptation will actually work to their long-term benefit. This webinar will discuss and evaluate the effects that this call for change has on a company and its change control policies and systems.

Control and review of device changes are a major requirement in determining when to file a new 510(k). Change can be beneficial, but is often the cause of new and even worse problems than those the change was designed to eliminate. It can be the root cause of a major problem, cGMP "entropy". Proper change control is hard to achieve but required to resolve any underlying compliance issues or product problems that are increasingly seen by regulatory agencies and consumers worldwide. To meet these regulatory challenges and remain competitive, companies need to continually reevaluate their change control system and its impact on all areas of a company's cGMP activities.

Why should you attend:
The last few years have seen an increase in product problems. For this and other reasons, the U.S. FDA has come under increasing negative public scrutiny. High profile drug recalls, food chain problems and contamination, import problems, resignations. Larger, higher profile companies are coming under FDA investigation activities. Many failings can be traced to poor or weakly documented Change Control. Documented and reviewed Change Control is crucial to device 510(k) submission requirements. Yet it often is a company's weakest link in compliance - proven by these recent high-profile failures. Why so? What are FDA expectations? Where are the most likely failure points? How are successful companies meeting this challenge. Tools that need to be put in place or enhanced. Getting staff and line personnel buy-in. Getting senior management buy-in. And getting supplier buy-in.

Areas Covered in the Session:
  • Change Control - what it is; what it is not
  • Areas impacted by Change Control
  • Regulatory / FDA 483 "Hot Buttons"
  • Design Control and Filing a New 510(k)
  • Document Control
  • Identifying Changes
  • Preventing Negative Changes and Entropy
  • Give the FDA It's Desired 'State of Control'
  • Business Needs and Obtaining Stakeholder 'Buy-In'

Who Will Benefit:
  • Senior management in Drugs, Devices, Biologics, Dietary Supplements
  • QA
  • RA
  • R&D
  • Engineering
  • Production
  • Operations
  • Consultants


Instructor : Jeff Kasoff
Product Id : 30379PACK

Overview: A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures. Since FDA cannot regulate component suppliers, it is imperative that your company's purchasing and supplier control requirements provide the assurance that only acceptable components are used to manufacture finished devices.

Most medical device manufacturers have acceptable systems in place to assure component quality. But what about supplier quality? Your company must have a procedure in place that describes the methods you use to evaluate potential suppliers, and set forth requirements that your suppliers must meet to be considered “approved.” You must also have a system in place to routinely assess your suppliers, and set forth the applicable criteria they must meet to remain “approved.” You may never have to pay a visit to your supplier if you have a great supplier control program in place.

Areas Covered in the Session:
  • QSR and ISO 13485 requirements for supplier selection and assessment
  • How to qualify new suppliers in a cost efficient manner
  • How to assess current suppliers in a cost efficient manner
  • How to perform supplier-related corrective action
  • Minimum documentation requirements for supplier qualification, assessment, and related corective action

Who Will Benefit: This webinar will provide valuable assistance to all regulated companies that are interested in implementing a supplier management program that is both compliant and cost-efficient. The employees who will benefit include:
  • Purchasing management
  • Regulatory management
  • QA management
  • Consultants


Instructor : John E Lincoln
Product Id : 30379PACK

Overview: The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".

This is a major headache. How can companies make that determination? How can they trigger such an analysis over the major change or the series of smaller changes. What approaches are required for product changes; for process changes. How is the process risk-based? How to maximize the process against scarce resources. What are the different considerations for CE-marked product?

Areas Covered in the Session:
  • U.S. FDA device clearance / approval
  • FDA's and EU's emphasis
  • Product changes and filing a new 510(k) - who's responsible
  • Tracking and evaluating changes - the "tipping point"
  • Is the process "risk based"?
  • K-97-1 and the FDA's "Decision Tree"
  • Documenting the process / rationale
  • Resolving a "wrong decision"

Who Will Benefit:
  • Senior management, project leaders, internal / external consultants
  • Regulatory affairs
  • Quality systems personnel / QAE
  • R&D and engineering staff
  • Personnel involved in Lean and Six Sigma Initiatives
  • New product development, regulatory submissions, driving company-wide quality initiatives, under a risk-justified approach
  • CAPA personnel desiring to minimize post-production / life cycle, root cause investigation, and other costly problems.


Instructor : Dan OLeary
Product Id : 30379PACK

Overview: When your firm finds a problem with one of the devices you already shipped, fix it for the customer. Do you report it to the FDA?

If you send a letter to a customer that says, "We found a problem, but, not to worry, we will fix it for you!", you may have invoked the Corrections and Removals process. Under Part 806 of the FDA regulations, you must report this event to FDA. Under certain circumstances, you may not need to report, but you must keep a record of your decision. You need to make sure you know the when to report and when a record is adequate.

Why should you attend: An FDA Inspection will check for Corrections and Removals during an inspection. Often Inspectors will check specific actions, since they will monitor your website and usually get a copy of letters you sent to customers. If you send a letter that notifies your customers of a problem, it will almost certainly get to a competitor who will send a copy to FDA. If you didn’t report to FDA, the Inspector will ask for your records documenting the reason not to report.

Participant will learn:
  • The requirements of Part 806 including the difference between reports and records
  • The difference between a correction and a removal and how to report them
  • The exceptions in Part 806 and how to apply them to make the reporting decision
  • What an Inspector will look for in a QSIT inspection
  • What to look for in an effective program and how to ensure your program makes the grade
  • The results of Warning Letters and how you can avoid some of the same issues
  • The relationship with design changes and the potential need to update a 510(k)

Areas Covered in the Session
  • The basic requirements of Part 806
  • When to report
  • Exemptions that you may apply
    • Market withdrawal
    • Routine servicing
    • Stock recovery
    • Reporting under Part 803 - Medical Device Reports
    • Reporting under Part 1004 - Repurchase, Repairs, or Replacement of Electronic Products
  • The requirements of a report and the timing
  • The requirements for records when you don’t report
  • The expectations of a QSIT Inspection
  • Elements of a robust system
  • How to check your system for compliance
  • Recalls
  • Design changes and potential 510(k) submissions
    • The current guidance
    • The draft guidance

Who Will Benefit:
  • Quality Professionals
  • Regulatory Professionals
  • Risk Management Specialists
  • Complaint Managers and Specialists
  • Compliance Officers
  • General/Corporate Counsel
  • Regulatory/Legislative Affairs Professionals


Instructor : John E Lincoln
Product Id : 30379PACK

Overview: U. S. FDA-regulated companies are responsible for understanding current Good Manufacturing Practices (CGMPs) as defined in the Code of Federal Regulations ( 21 CFR Part 111, 210/211, and 820).

They are then required to translate those regulations into procedures and work instructions. Many companies who have successfully done that in the past are now failing audits, facing major recall, and multi-million dollar fines. What failures in the cGMPs have led to this? What assumptions have proven to be invalid? What are the key areas of non-compliance? What can be done in a company to look for, validate or correct to prevent it from being the next news headline or "60 Minutes" feature? Can the "new" "Zero Defects" provide the answers? What is ZD in a cGMP environment? What are the ZD and culture advantages and pitfalls?

Why should you attend: The last few years have seen several major "names" in drugs and devices stumble over quality and cGMP issues, resulting in recalls, lawsuits, and even possible criminal prosecution. Other recent drug recall is resulting in several class action lawsuits. A growing push by the Agency to get tougher and strengthen enforcement is one result. Bad publicity affecting once stellar names in the regulated industry is another. Public outcry for a more proactive FDA is yet another. Class action lawsuits. Current FDA oversight methods are claimed to not be providing the product safety or efficacy seemingly promised. Is the renewed interested in 'Zero Defects" the answer. Is it the proactive response to address these concerns and better ensure better regulatory compliance? Such high-profile field problems indicate that issues such as senior management involvement, product risk management, validation and change control and similar requirements are somehow being short-circuited. Does a successful U.S. Air Force / aerospace quality program of the 1960's, and the cry by a prominent quality guru of the 1970's hold the answer, or is it just another "flavor of the month"? Most importantly, could it work at your company?

Areas Covered in the Session:
  • The "tougher" U. S. FDA and Regulatory "Hot Buttons"
  • Recent news headlines - prominent / respected company failures
  • What is "Zero Defects"?
  • "Zero Defects" and Deming, Juran and Cosby -- a Study in Contrasts
  • "Zero Defects" Pros and Cons in the Regulatory Environment
  • "Zero Defects" in Problem-prone Areas
  • Zero Defects and Entropy
Who Will Benefit:
  • Senior Management in Drugs, Devices, Biologics, Dietary Supplements
  • QA
  • RA
  • R&D
  • Engineering
  • Production
  • Operations
  • Consultants; others tasked with product, process, validations, CGMP responsibilities


Instructor : David R Dills
Product Id : 30379PACK

Overview: An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.

The results of this evaluation should lead to a conclusion regarding whether the complaint was valid, what the root cause of the complaint was, and what action is necessary to prevent further occurrences. Complaints cannot be ignored. They are an excellent indicator of problems with the use, design, and/or manufacture of a product. A single complaint that is thoroughly investigated may lead a company to take remedial or corrective action. It may also take an ongoing analysis of numerous complaints before a trend is spotted that causes a company to initiate changes in their product, labeling, packaging or distribution. The regulatory expectations for both pharmaceuticals and medical devices will be emphasized as well as overview of best practices for timely and effective investigations.

Areas Covered in the Session:
  • Understand how and why CAPA is tied in to product complaint investigations
  • Examples of tools currently being used to conduct investigations
  • How far and in-depth do you go with your investigations
  • What are current FDA "hot" buttons and trends
  • Benchmarks and best practices for investigations
  • How to become a "good" investigator and the emphasis on closed-loop investigations
  • Why risk-based approaches are vital to the decision-making process
  • How to improve and bullet-proof your product complaint management system with investigations

Who Will Benefit:
  • All levels of Management for all departments and those who desire a better understanding
  • QA/QC/Compliance/Regulatory Affairs
  • Marketing & Sales & Customer Service
  • Engineering/Technical Services
  • Consultants
  • Operations and Manufacturing

David R. Dills, is Director of Regulatory Services at CROMSOURCE, an international contract research organization (CRO) to the pharmaceutical, biotechnology, and medical device industries. Mr. Dills has more than 28 years of experience in the medical device and pharmaceutical industry. He has held positions of increasing responsibility with sponsor and service companies of various sizes, including large, global OEM’s/sponsors, consultancies and a global CRO, as well as virtual, small, mid and large-sized enterprises and has serviced sponsors and clients in multiple global locations. Mr. Dills’ most recent position was President and Principal, Global Regulatory Affairs Consultant with a consultancy in the US, and prior to that he served in senior level regulatory and compliance roles for various organizations.

He has a range of expertise in different therapeutic areas and medical specialties for pharma and medical devices, including combination products. David enjoys interpreting the regulatory precedents and new legislation, developing the regulatory strategy as part of strategic regulatory consulting, Agency meeting preparation and engagement, conducting persuasive communication with regulatory authorities, executing an effective path to approval for submissions and marketing applications with multi-country registrations and approvals, developing GxP compliance strategies from premarketing to postmarketing from R&D, Manufacturing/Operations, Postmarket and to delivering regulatory and compliance training to internal and external stakeholders, and striving for overall corporate compliance with regulations in The Americas, EMEA and Asia Pacific.

He has managed regulatory and compliance projects with multiple competing priorities having a direct impact on site operations commercial opportunities and enjoys adding business value to clients by providing strategic and tactical solutions that facilitate the achievement of regulatory and compliance milestones and on minimizing delays due to noncompliance and regulatory risk. He has worked directly with global manufacturers and sponsors engaged in compliance remediation activities and services involving enforcement actions and customer generated compliance events, inspection preparation, among other regulatory and compliance responsibilities.

Instructor : David R Dills
Product Id : 30379PACK

Overview: What is a combination product? What are some examples of combination products? How are combination products assigned for review? Where can I find guidance for how master files can be used in the submission of information relevant to my combination product? Determine which Center will review my combination or non-combination product?

These topics and more will be addressed during this Webinar, including recently FDA's proposed rule to codify the current good manufacturing practice (cGMP) requirements applicable to combination products. This proposed rule is intended to promote the public health by clarifying which cGMP requirements apply when drugs, devices, and biological products are combined to create a combination product. In addition, the proposed rule sets forth a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with cGMP requirements for "single-entity" and "co-packaged" combination products. FDA proposes to create 21 CFR Part 4, subpart A, to codify the cGMP requirements that apply to combination products. What current good manufacturing practice requirements apply to my combination product? The proposed rule seeks to clarify which cGMP requirements apply when drugs, devices, and biological products are used to create combination products. The agency notes that there are no express preemption provisions of the act applicable to prescription drugs or biological products.

Areas Covered in the Session:
  • Introduction to Combination Products if you design, develop, produce, distribute and deploying a sustainable regulatory strategy
  • Description and explanation of FDA's proposed rule
  • Requirements for Single-Entity and Co-Packaged Combination Products
  • Identify requirements that apply to the constituent parts of a Combination Product before they are combined, or packaged together
  • What current good manufacturing practice requirements apply to my combination product?
  • Learn FDA's new terms and phrases
  • Understand how to address a Request for Designation for a combination or non-combination product and examples of "combo" products
  • Resources and guidance to help define a proven regulatory strategy

Who Will Benefit:
  • All levels of management and departmental representatives and those who desire a better understanding or a "refresh" overview
  • Regulatory Affairs
  • Clinical Affairs
  • Quality and Compliance
  • Marketing & Sales
  • Distributors
  • Engineering/Technical Services/Operations
  • Consultants

David R. Dills, is Director of Regulatory Services at CROMSOURCE, an international contract research organization (CRO) to the pharmaceutical, biotechnology, and medical device industries. Mr. Dills has more than 28 years of experience in the medical device and pharmaceutical industry. He has held positions of increasing responsibility with sponsor and service companies of various sizes, including large, global OEM’s/sponsors, consultancies and a global CRO, as well as virtual, small, mid and large-sized enterprises and has serviced sponsors and clients in multiple global locations. Mr. Dills’ most recent position was President and Principal, Global Regulatory Affairs Consultant with a consultancy in the US, and prior to that he served in senior level regulatory and compliance roles for various organizations.

He has a range of expertise in different therapeutic areas and medical specialties for pharma and medical devices, including combination products. David enjoys interpreting the regulatory precedents and new legislation, developing the regulatory strategy as part of strategic regulatory consulting, Agency meeting preparation and engagement, conducting persuasive communication with regulatory authorities, executing an effective path to approval for submissions and marketing applications with multi-country registrations and approvals, developing GxP compliance strategies from premarketing to postmarketing from R&D, Manufacturing/Operations, Postmarket and to delivering regulatory and compliance training to internal and external stakeholders, and striving for overall corporate compliance with regulations in The Americas, EMEA and Asia Pacific.

He has managed regulatory and compliance projects with multiple competing priorities having a direct impact on site operations commercial opportunities and enjoys adding business value to clients by providing strategic and tactical solutions that facilitate the achievement of regulatory and compliance milestones and on minimizing delays due to noncompliance and regulatory risk. He has worked directly with global manufacturers and sponsors engaged in compliance remediation activities and services involving enforcement actions and customer generated compliance events, inspection preparation, among other regulatory and compliance responsibilities.

Instructor : John E Lincoln
Product Id : 30379PACK

Overview: Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system.

It is required in resolving verification and validation issues including data outliers that frequently but are often improperly dismissed arbitrarily. It is required in order to "close-the-loop" on corrective and/or preventive actions (CAPA), and do proper impact analysis / actions. Such failure investigation and root cause analysis is a major element of cGMP compliance. If inadequately performed it is also a key source of regulatory problems. How can companies allocate scarce resources to those activities that have the greatest impact to product quality / safety, minimize resources on minor issues, and still satisfy the regulatory agencies? How can line operators' brains be engaged by the use of such simple yet powerful tools? Use the templates, tools and methodology presented in this webinar to facilitate a closed-loop problem resolution system to reduce "fire fighting" and minimize compliance problems.

Why you should attend: Expectations for meaningful CAPA, supported by results-driven Failure Investigation and Root Cause Analysis, that addresses and resolves underlying product problems, are growing among regulatory agencies world-wide. EU's ISO 14971 (Device Risk Management) and the FDA's QSIT (devices) and ICH Q9 (drugs), underscore this increased emphasis. A valid closed-loop CAPA system requires defined failure investigation including systemic root cause analysis for true problem (not symptom) resolution. Growing high-profile field problems indicate that such effective and repeatable failure investigation and root cause analysis is still not the industry norm.

The billions of dollars spent by industry annually on quality / GMP are not providing the product safety or efficacy seemingly promised. And for most companies, the fixes are not rocket-science, but proper up-front risk-based, closed-loop failure investigation / root cause analysis as an integral part of CAPA, Validation and Quality Management Systems / cGMP planning, implementation and execution.

Areas Covered in the Session:

  • Regulatory "Hot Buttons"
  • The 4 Basic Steps to Problem Solving
  • A Suggested Investigation Template
  • ID / Document the Problem - CAPA, et al
  • Failure Investigation / Analysis Methodology - And One Possible Template
  • Use the 7 Tools to Find the Solution(s)
  • Monitor for Effectiveness
  • Lock In the Change - Close the Loop
  • Take It to the Next Level

Who Will Benefit:
  • Senior management in Drugs, Devices, Biologics, Dietary Supplements
  • QA
  • RA
  • R&D
  • Engineering
  • Production
  • Operations
  • Consultants; others tasked with product, process, CAPA resolution, failure investigation responsibilities


Instructor : David R Dills
Product Id : 30379PACK

Overview: An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.

The results of this evaluation should lead to a conclusion regarding whether the complaint was valid, what the root cause of the complaint was, and what action is necessary to prevent further occurrences. Complaints cannot be ignored. They are an excellent indicator of problems with the use, design, and/or manufacture of a product.

A single complaint that is thoroughly investigated may lead a company to take remedial or corrective action. It may also take an ongoing analysis of numerous complaints before a trend is spotted that causes a company to initiate changes in their product, labeling, packaging or distribution. The regulatory expectations for both pharmaceuticals and medical devices will be emphasized as well as overview of best practices for timely and effective investigations.

Areas Covered in the Session:
  • Understand how and why CAPA is tied in to product complaint investigations
  • Examples of tools currently being used to conduct investigations
  • How far and in-depth do you go with your investigations
  • What are current FDA "hot" buttons and trends
  • Benchmarks and best practices for investigations
  • How to become a "good" investigator and the emphasis on closed-loop investigations
  • Why risk-based approaches are vital to the decision-making process
  • How to improve and bullet-proof your product complaint management system with investigations

Who Will Benefit:
  • All levels of Management for all departments and those who desire a better understanding
  • QA/QC/Compliance/Regulatory Affairs
  • Marketing & Sales & Customer Service
  • Engineering/Technical Services
  • Consultants
  • Operations and Manufacturing

David R. Dills, is Director of Regulatory Services at CROMSOURCE, an international contract research organization (CRO) to the pharmaceutical, biotechnology, and medical device industries. Mr. Dills has more than 28 years of experience in the medical device and pharmaceutical industry. He has held positions of increasing responsibility with sponsor and service companies of various sizes, including large, global OEM’s/sponsors, consultancies and a global CRO, as well as virtual, small, mid and large-sized enterprises and has serviced sponsors and clients in multiple global locations. Mr. Dills’ most recent position was President and Principal, Global Regulatory Affairs Consultant with a consultancy in the US, and prior to that he served in senior level regulatory and compliance roles for various organizations.

He has a range of expertise in different therapeutic areas and medical specialties for pharma and medical devices, including combination products. David enjoys interpreting the regulatory precedents and new legislation, developing the regulatory strategy as part of strategic regulatory consulting, Agency meeting preparation and engagement, conducting persuasive communication with regulatory authorities, executing an effective path to approval for submissions and marketing applications with multi-country registrations and approvals, developing GxP compliance strategies from premarketing to postmarketing from R&D, Manufacturing/Operations, Postmarket and to delivering regulatory and compliance training to internal and external stakeholders, and striving for overall corporate compliance with regulations in The Americas, EMEA and Asia Pacific.

He has managed regulatory and compliance projects with multiple competing priorities having a direct impact on site operations commercial opportunities and enjoys adding business value to clients by providing strategic and tactical solutions that facilitate the achievement of regulatory and compliance milestones and on minimizing delays due to noncompliance and regulatory risk. He has worked directly with global manufacturers and sponsors engaged in compliance remediation activities and services involving enforcement actions and customer generated compliance events, inspection preparation, among other regulatory and compliance responsibilities.

Instructor : John E Lincoln
Product Id : 30379PACK

Overview: This webinar will discuss the 9 required elements of a Design Control System. It will consider different methods of implementation, and expectations of the U.S. FDA, proven by documentation.

Such an analysis takes on added urgency as a result of the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what it (the FDA and industry) need to do to "toughen" the safety and efficacy of medical devices. A review of recent information from the Agency, including recent Working Group findings and Reports, as well as other goals of the Agency that have already been translated into action in the field in the past two years, provide further direction in areas of concern and what to expect in the future. Anticipation and addressing such on-going increased Agency emphasis in product design and modifications - change control proactively will further prove a company is "in control" re: the CGMPs, and assist documenting entire medical product development process.

Why should you attend: The FDA expects companies to perform meaningful, results driven Design Control activities as defined in the CFR, for both new and changed devices. The company is held fully responsible for deciding when to start and the specific documentation to meet the 9 requirements. Beyond compliance, these 9 elements can be a powerful tool in reducing "time to market" - "fast cycle" product development.

In addition, growing high-profile field problems indicate that design control and it's effect on regulatory review activities are not yet fully utilizing the power of current risk management tools, which must be a part of the design control process - the ISO 14971 "model". A growing push by the Agency to strengthen the 510(k) process, and review existing devices with above normal adverse events are additional concerns, to be factored into the design control process. The resulting documentation can have other far-reaching uses in a company. Proper design control requires a defined "start" date, and the systematic - SOP-defined implementation of formal methods with documented, and defensible, rationale. When properly executed, it is a powerful product development project management tool.

Areas Covered in the Session:
  • FDA Device Clearance - Changes in Direction
  • Current Design Control Requirements
  • Defining the "Start" Date and Its Significance
  • The 9 Design Control Elements and Their Implementation and Documentation
  • Their Implementation and Documentation
  • "Retroactive" Design Control
  • The Business Case for Design Control

Who Will Benefit:
  • Senior management in Devices and Combo Products
  • QA
  • RA
  • R&D
  • Engineering
  • Production
  • Operations
  • Consultants


Instructor : John E Lincoln
Product Id : 30379PACK

Overview: It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Also considered: Areas requiring frequent re-evaluation / update; Similarities and differences; Future trends; Typical DHF Table of Contents; Technical File or Design Dossier Table of Contents; The importance and usefulness of the "Essential Requirements"; Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed; Parallel approaches to development. Finally, the differing approaches to file audits by the FDA and the Notified Body will be discussed.

Why should you attend: One of our most popular webinars, continuously updated with the latest U.S. FDA and European Union requirements. As U.S. companies go global, they must meet different product design documentation. The cGMPs mandate Design Control and the Design History File (DHF). In order to sell globally, the EU's CE-marking documentation is a requirement - the Technical File or Design Dossier. Currently they serve different purposes, support different goals, but the TF/DD is moving in the direction of the DHF. And the DHF is adapting to some of the features of the TF/DD. And how / where do the DMR and DHR fit? Being aware of the similarities and differences in the files and their individual documents can further concurrent development and/or updates to both.

Areas Covered in the Session:
  • The EU's MDD and the Technical File / Design Dossier
  • Device Classification - U.S. FDA vs. EU MDD
  • Design Control 'Over Time' vs. a Product's 'Snapshot in Time' - Differing Philosophies
  • DHF "Typical" Contents and Deliverables
  • The DMR and DHR / Lot / Batch Record
  • TF / DD Required Contents
  • Parallel Approaches to Documentation - Teams
  • FDA and NB Audit Focus

Who Will Benefit:
  • Senior management in Drugs, Devices, Biologics, Dietary Supplements
  • QA
  • RA
  • R&D
  • Engineering
  • Production
  • Operations
  • Marketing


Instructor : John E Lincoln
Product Id : 30379PACK

Overview: FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning.

Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols. How to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents, against a background of limited company resources (personnel, budget, time). A matrix simplifies "as-product", "in-product", process, and equipment, et al, software V&VT, assuring key FDA requirements are not overlooked. The QMS and 21 CFR Part 11 must be considered.

Why should you Attend: Verification and validation requirements have always been part of the US FDA's GMPs. However, with increasing technology, both industry and regulatory agencies expectations have increased. Recent high-profile field problems indicate that V&V activities are not planned or carried out as completely as expected, and may not be fully utilizing the power of current risk management tools, as identified in ISO 14971. The billions of dollars spent by industry annually for V&V are not providing the product safety or efficacy seemingly promised. For most companies, the fixes are not rocket-science, but proper up-front V&V planning and execution.

Areas Covered in the Session:
  • Verification or Validation - Recent regulatory expectations
  • The Master Validation Plan / structure
  • Product Validation - how it differs from process / equipment V&V
  • Process / Equipment / Facility Validation - FDA's new guidance
  • When and How to use DQ, IQ, OQ, PQ, or their equivalents
  • How to use Product Risk Management Tools (per ISO 14971 and ICH Q9)
  • The 11 key documents for software validation
  • Incorporating 21 CFR Part 11 requirements
  • Suggested "test case" formats

Who Will Benefit:
  • Senior management in Drugs, Devices, Biologics, Dietary Supplements
  • QA
  • RA
  • R&D
  • Engineering
  • Production
  • Operations
  • Consultants; others tasked with product, process, software ... validation responsibilities


Instructor : David R Dills
Product Id : 30379PACK

Overview: There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review process.

Product modifications that could significantly affect safety and effectiveness are subject to 510(k) submission requirements under 21 CFR 807 as well as design control requirements under the Quality System (QS) regulation. Under the QS regulation, all Class II and III devices and certain Class I devices are required to be designed in conformance to 21 CFR 820.30 Design Controls. FDA provides guidance and this course will address key resources when making critical decisions.

Objectives:
  • Know the differences between the Traditional, Special and Abbreviated submissions
  • Understand Substantial Equivalence and how it is applied
  • Who is required to submit the application to FDA
  • Where to submit the 510(k) and what to expect with the review and approval process
  • When it is and is not required if you are a device company
  • Exemptions to the submission process and special considerations
  • How to locate a "predicate" device and go through the content and format of the 510(k)
  • Understand the De Novo process and the expectations for possibly marketing a low risk device
  • Understand the potential impact of FDA's proposed changes to the 510(k) process and why manufacturers need to pay attention
Detailed Agenda:

Introduction and Regulatory Background
  • There is no 510(k) form; however, 21 CFR 807 Subpart E describes requirements for a 510(k) submission.
  • Current trends with the 510(k) process.
The Process
  • Who is Required to Submit a 510(k)
  • When a 510(k) is Not Required
  • When a 510(k) is Required
  • Locating and justifying the Predicate
  • Substantial Equivalence and demonstration of SE to another legally U.S. marketed device
  • How to Prepare Submissions
  • 510(k) Submission Methods
  • List of forms associated with Premarket Notification 510(k) submissions
  • Deciding When to Submit a 510(k) for a Change to an Existing Device
  • What happens if FDA requires additional information and data and your responsibilities
Interactive Q&A, Wrap-Up and Adjourn

  • Q&A with all attendees
  • Group discussion and review of recent 510(k) clearances and proposals and recommendations between FDA and industry
  • Discussion Points: some of the recommendations have included, but not limited to, redefining fundamental terms, limiting use of predicates, greater authority to rescind 510(k)s, etc.
  • 510(k) Frequently Asked Questions
  • Attendees should be prepared to address any issues and challenges as experienced on behalf of their company in this open-forum and interactive session

Who Will Benefit:
  • This course is appropriate to those involved in all aspects of the premarket notification, i.e., 510(k) process on behalf of medical device and In Vitro Diagnostic manufacturers. It is both a primer for personnel new to the FDA 510(k) process, or an excellent refresher course for those who need to revisit the basics and fundamentals for a better understanding on how to prepare and submit your application to ensure regulatory and compliance success. Those who will benefit include professionals in R&D, development, quality assurance and quality control, production, operations, engineering, compliance, and regulatory affairs and all levels of management, including technical and laboratory personnel who desire to understand what it takes to prepare and submit a bulletproof 510(k) to FDA while at the same time are aware of the changing regulatory landscape regarding FDA's proposed changes to the 510(k) process.

David R. Dills, is Director of Regulatory Services at CROMSOURCE, an international contract research organization (CRO) to the pharmaceutical, biotechnology, and medical device industries. Mr. Dills has more than 28 years of experience in the medical device and pharmaceutical industry. He has held positions of increasing responsibility with sponsor and service companies of various sizes, including large, global OEM’s/sponsors, consultancies and a global CRO, as well as virtual, small, mid and large-sized enterprises and has serviced sponsors and clients in multiple global locations. Mr. Dills’ most recent position was President and Principal, Global Regulatory Affairs Consultant with a consultancy in the US, and prior to that he served in senior level regulatory and compliance roles for various organizations.

He has a range of expertise in different therapeutic areas and medical specialties for pharma and medical devices, including combination products. David enjoys interpreting the regulatory precedents and new legislation, developing the regulatory strategy as part of strategic regulatory consulting, Agency meeting preparation and engagement, conducting persuasive communication with regulatory authorities, executing an effective path to approval for submissions and marketing applications with multi-country registrations and approvals, developing GxP compliance strategies from premarketing to postmarketing from R&D, Manufacturing/Operations, Postmarket and to delivering regulatory and compliance training to internal and external stakeholders, and striving for overall corporate compliance with regulations in The Americas, EMEA and Asia Pacific.

He has managed regulatory and compliance projects with multiple competing priorities having a direct impact on site operations commercial opportunities and enjoys adding business value to clients by providing strategic and tactical solutions that facilitate the achievement of regulatory and compliance milestones and on minimizing delays due to noncompliance and regulatory risk. He has worked directly with global manufacturers and sponsors engaged in compliance remediation activities and services involving enforcement actions and customer generated compliance events, inspection preparation, among other regulatory and compliance responsibilities.

Instructor : David R Dills
Product Id : 30379PACK

Overview: This webinar will provide an overview and guidance to firms that are either going through or preparing to go postmarket surveillance activities.

This guidance document is being distributed for comment purposes only and will be of benefit for medical device manufacturers and the document was issued on August 16, 2011. Postmarket surveillance under section 522 of the Federal Food, Drug, and Cosmetic Act (the act) is one means by which the Food and Drug Administration (FDA) can obtain additional safety and/or effectiveness data for a device after it has been cleared through the premarket notification (510(k)) process or approved through the premarket approval application (PMA), humanitarian device exemption (HDE), or product development plan (PDP) process, when it is necessary to protect the public health. Postmarket surveillance is not a substitute for obtaining the necessary premarket information to support 510(k) clearance or PMA, HDE, or PDP approval.

This guidance document is intended to assist those subject to section 522 postmarket surveillance imposed by FDA by providing: an overview of section 522 of the act, procedural information on how to fulfill 522 obligations, and recommendations on the format, content, and review of postmarket surveillance study submissions. Substantive additions to the 2006 version of this guidance document will be addressed.

Areas Covered in the Session:
  • Review proposed changes
  • Explain the legal background and overview of statutory criteria
  • Considerations regarding pediatric population provisions
  • Understand expectations for postmarket surveillance study duration
  • Describe the postmarket surveillance process and identification of issue
  • Why an order for postmarket surveillance will issued under section 522
  • Learn why postmarket surveillance study plans are reviewed as an original submission and its amendments until the plan is approved
  • Determine the elements to Include in a Postmarket Surveillance Study Plan
  • Understand why FDA may order postmarket surveillance to address a wide variety of device-related public health questions
  • Current expectations for different stages of Postmarket Surveillance Study Reports
  • Why happens if you fail to complete a Postmarket Surveillance Study

Who Will Benefit:
The employees who will benefit include: All levels of management and departmental representatives and those who desire a better understanding with FDA’s draft guidance on financial disclosure by clinical investigators, including:
  • Regulatory Affairs
  • Clinical Affairs
  • Investigators
  • Quality and Compliance
  • Marketing & Sales
  • Distributors/Authorized Representatives
  • Legal Counsel
  • Consultants

David R. Dills, is Director of Regulatory Services at CROMSOURCE, an international contract research organization (CRO) to the pharmaceutical, biotechnology, and medical device industries. Mr. Dills has more than 28 years of experience in the medical device and pharmaceutical industry. He has held positions of increasing responsibility with sponsor and service companies of various sizes, including large, global OEM’s/sponsors, consultancies and a global CRO, as well as virtual, small, mid and large-sized enterprises and has serviced sponsors and clients in multiple global locations. Mr. Dills’ most recent position was President and Principal, Global Regulatory Affairs Consultant with a consultancy in the US, and prior to that he served in senior level regulatory and compliance roles for various organizations.

He has a range of expertise in different therapeutic areas and medical specialties for pharma and medical devices, including combination products. David enjoys interpreting the regulatory precedents and new legislation, developing the regulatory strategy as part of strategic regulatory consulting, Agency meeting preparation and engagement, conducting persuasive communication with regulatory authorities, executing an effective path to approval for submissions and marketing applications with multi-country registrations and approvals, developing GxP compliance strategies from premarketing to postmarketing from R&D, Manufacturing/Operations, Postmarket and to delivering regulatory and compliance training to internal and external stakeholders, and striving for overall corporate compliance with regulations in The Americas, EMEA and Asia Pacific.

He has managed regulatory and compliance projects with multiple competing priorities having a direct impact on site operations commercial opportunities and enjoys adding business value to clients by providing strategic and tactical solutions that facilitate the achievement of regulatory and compliance milestones and on minimizing delays due to noncompliance and regulatory risk. He has worked directly with global manufacturers and sponsors engaged in compliance remediation activities and services involving enforcement actions and customer generated compliance events, inspection preparation, among other regulatory and compliance responsibilities.

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