Medical OEM Design Control Audit: Anticipation and Expectations

Scheduled On : Tuesday, April 15, 2014 at 1 PM EDT | 10 AM PDT

Duration : 60 Minutes

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Description : 

This 60 minute webinar on a Design Control Audit by the FDA and other bodies will provide an understanding of what a medical OEM should anticipate during an audit during a design control audit. All medical device companies that are in need of examining their design control process should be aware of what to expect.

The FDA and other authorizing bodies have become more stringent in their examination of medical OEM procedures, process, and data. Many medical industry companies have not completed all their testing and design reviews before commercializing products properly or brought their mature product lines up to current FDA standards and are not in total compliance. This webinar shows the process to be followed for developing a standard procedure to identify what is expected for design control.

For example, companies should be compliant to 21 CFR 820, ISO 13485:2003, ISO 14971:2007, etc. Design History Files and validations need to be up to date to meet current standards. The FDA and other authorizing bodies expect continuous improvement and risk management to be integrated into the company quality system. Old medical devices need to have a risk assessment for each product and updated validations for product and processes. It should describe the risk acceptance criteria as well as roles and responsibilities of each member on the team.

In this webinar, we will discuss practical steps you can follow to make sure your product design control and quality files are ready for an audit. It will also give the attendee guidelines on how to deal with the authorizing bodies.

Areas Covered in the Session :

• Champion/Multi-functional team approach/responsibility
• Dealing with the FDA and other authorizing bodies
• Phase by phase design process check list
• Design input/output
• Design verification/validation
• Design changes
• Design review
• Design History File (DHF)
• Due-diligence
• Gap analysis – data gathering for the design history files
• Risk assessment
• Design changes
• 483 warning letters
• Planning to be prepared

Who Will Benefit: 

This webinar will provide valuable assistance and give a process to all medical device and regulated companies that need to prepare for an FDA or authorizing bodies audit in the future. The employees who will benefit include:

• OEM and CMO quality managers
• OEM and CMO quality engineers
• End-users responsible for design control and technical files
• R&D and product development 
• Process engineers and managers
• Operations and plant management
• Validation engineers
• Remediation teams
• QA, Regulatory Affairs
• QC and Corporate Auditors
• All team members who contribute to design history files, clinical, verifications/validations, risk management or technical files
• Consultants
• Project managers
• Supplier management
• Product transfer engineers
• All Contract Manufacturers working in the medical industry

Speaker Profile

Robert Braido has 40 years of experience in the medical industry. He is president of Visionary Consulting LLC and has been consulting with medical OEM’s and CMOs for over 7 years. Mr. Braido’s has a broad breadth of medical industry experience in prototype/product development, global strategic/tactical planning, technical due-diligence/gap analysis for acquisitions, engineering, operations and business development. He has had great success working at Ethicon Endo-Surgery a J&J Company, Baxter Healthcare, Teleflex Medical, GW Plastics and The Tech Group with increasing responsibilities to the level of VP of Advanced Technologies. He was a member of the Board of Directors for the Society of Plastic Engineers Medical Division for over 10 years and elected Chairman of the Medical Division twice..more

FDA Guidance: Design Considerations for Pivotal Clinical Investigations for Medical Devices

Scheduled On : Monday, April 14, 2014 at 1 PM EDT | 10 AM PDT

Duration : 90 Minutes

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Description : 

This webinar introduces FDA’s guidance “Design Considerations for Pivotal Clinical Investigations in Medical Devices” that was published in late 2013. It discusses the regulatory considerations for clinical study design, and delves into the issues of bias and variance that may impact the quality of the data obtained in the study, as well as the interpretation of the data.

Following that, it discusses way that are available to a medical device sponsor, for eliminating bias and variance, both in terms of the study design and the requirements for the personnel that will design and run the studies. Finally, it touches on the study protocol and statistical plan and discusses ways to use those to ensure the success of the study.

In November 2013 the FDA issued the Guidance “Design Considerations for Pivotal Clinical Investigations for Medical Devices” to provide guidance to Industry, Clinical Investigators and Institutional Review Boards, on the study design principles relevant to the development of medical device clinical studies. Even though this guidance is focused on is providing recommendations to sponsors on how to design clinical investigations to support a PMA, sponsors who conduct clinical studies to support pre-market notification (510(k)) and de novo submissions may also rely on the principles in this guidance document.

Each year, insufficient evidence of the safety and effectiveness of a medical device caused from incorrect study design, results in the delay or rejection of either the medical device application or studies conducted towards that application. This is very expensive for the medical device sponsor who has to do additional work or redo existing work. It is also very expensive for the FDA (or other regulatory authorities) who spend the time to review results from incorrectly designed studies.

To mitigate these issues and standardize the way industry design clinical studies, the FDA published the guidance “Design Considerations for Pivotal Clinical Investigations in Medical Devices” in late 2013. The FDA’s goal in publishing this guidance is to help device manufacturers select the appropriate trial design to:

• Better support and improves the quality of safety & effectiveness data submitted to the agency
• Lead to timelier FDA approval
• Speed patients’ access to new devices

Areas Covered in the Session :

• The Guidance
• General Principles
• Some Principles for the Choice of Clinical Study Design
• Clinical Outcome Studies
• Diagnostic Clinical Performance Studies
• Sustaining the Quality of Clinical Studies
• Summary
• Q&A

Who Will Benefit: 

• Clinical Trial Physician / Doctor
• Clinical Investigators
• Regulatory Affairs Management Team
• Quality Assurance Managers & Directors
• Clinical Research & Management Team
• Data Management Team
• Data Monitoring Managers & Directors
• Institutional Review Board
• Biostatisticians

Speaker Profile

Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. “Your Passport to Compliance”. She has 30 years of experience in the Life sciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance. Ms. Bazigos is the president of PRCSQA (Pacific Regional Chapter of the Society of Quality Assurance) a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), ASQ, DIA and RAPS and consults to Pharma / Biotech / Medical Device companies as well as investment groups on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA. She teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and Project Management both to investor groups and industry. More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She is on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and on the Stanford Who’s Who Registry for contributions to the Life science industry

Do's and Don'ts of the Sign-On Bonus Award

Scheduled On : Friday, April 11, 2014 at 1 PM EDT | 10 AM PDT

Duration : 60 Minutes

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Description : 

This session is all about opening the eyes of the hiring manager and breaking down the why and why-not of this recruiting strategy. It's easy to give away money, but should you when you don't need to?

We'll discuss exactly what a sign-on bonus award should be, and what it shouldn't be.  We'll look at how it works, and the thought processes behind-the-scenes that sets the stage for a decision; to offer or not to offer.

Attendees will be challenged by practical scenarios and real life circumstances to reflect on the practices of their own organizations - to consider how best to apply this recruiting tactic, or when to walk away. Because a hiring manager should consider whether the cost of a sign-on is ultimately going to be "worth it," or a waste of money. And they should be armed with the knowledge of how to go about actually offering such an award; when to make the offer, how to, to whom and of course how much?

Attendees will come away with a thorough understanding of the award and how it is used. They will also come away with a better understanding of whether they should or shouldn't.

It's not unusual for an offer of employment, especially for a management job, to include a one-time cash award, called a "sign-on bonus."  While it may be common in certain organizations, is it a good idea?  Is it an effective use of the company's money.  Or is it literally a thank you for a candidate agreeing to join your organization?

Recruiters will tell you that it's a wonderful tactic to use, but then again, their own performance is measured by the number of candidates saying "yes," so is their point of view objective?

Areas Covered in the Session :

This session will explore the following topics:

• What exactly is a sign-on bonus award?
• How it's used as a negotiating tool
• Common scenarios where sign-ons are used
• Why some feel that it's a good recruiting tactic
• Why some feel that it's a bad idea
• Practical advice for the "should I / shouldn't I?" question
• The unintended consequences

Who Will Benefit: 

This is a must attend webinar for all: 

• Compensation Practitioners
• HR Generalists
• Recruiting and Hiring Staff
• Compensation Department Managers
• Human Resources Department
• Leaders in Start up companies

Speaker Profile

Chuck Csizmar has a deep and broad experience in the design, implementation and communication of US and international compensation programs. Long recognized by WorldatWork as a Certified Compensation Professional (CCP) Chuck has been a practitioner working with US and International program design and development, global compensation review, acquisition and integration strategies, incentive and sales compensation, compensation training, expatriate programs, and performance management strategies. Chuck is Founder & Principal of CMC Compensation Group, specializing in analytic, project management and consultative services for US and International clients. He is also associated with several Human Resources consulting firms (US and International) as a subject matter expert for global compensation issues. Prior to establishing his own consulting firm Chuck was based in London on expatriate assignment as the Director of European Compensation & Benefits for Pitney Bowes. In this position he led the design and management of Total Reward programs in seventeen countries. He is a member of WorldatWork, the Society for Human Resource Management (SHRM) and the Florida HR People & Strategy Affiliate. He has been published as a subject matter expert in several national publications and provides original material for several professional association newsletters. He has developed and hosted numerous webinars and is a featured contributing author for several HR blogs.

Part 11 Compliance and the Role of Standard Operating Procedures

Scheduled On : Thursday, April 10, 2014 at 1 PM EDT | 10 AM PDT

Duration : 60 Minutes

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Description : 

21 CFR Part 11 describes the quality standards required of all computer systems used in FDA-regulated industry. This regulation provides the basic framework for computer systems used to generate records and data used for analysis and presentation. However, it is important to remember that not only are technical controls but there are procedural controls as well. In this seminar, we will simplify the regulatory requirements and provide practical tips in creating standard operating procedures that will have you ready for your next audit. We will also provide you with helpful tips when purchasing commercial off-the-shelf (COTS) software.

This seminar will discuss the basics of Part 11 requirements and needed procedural controls to maintain compliance. You will hear about validation requirements, system security protocols, access control, data backup, recovery and contingency plans, as well as change control. Case studies will be used to highlight common issues and potential solutions.

Areas Covered in the Session :

• Review the key 21 CFR Part 11 requirements
• Standard Operating Procedures for computer systems
• Validation of computer systems
• Tips when purchasing COTS software
• Common audit findings and tips for a successful audit

Who Will Benefit: 

This webinar will provide valuable information to: 

• Clinical trial sites, manufacturers, and sponsors
• Everyone involved in computer system validation 
• Anyone selecting computer systems intended for FDA regulated environments
• Information technology professionals responsible for files or network locations 
• Quality professionals who organize, document and verify system compliance
• Executives evaluating requirements Part 11 compliant systems

Speaker Profile

Herman Wong is a Washington DC-based consultant for computer systems in FDA-regulated industry. He has been in the industry for over 12 years and is the Director of the Information Technology department at Amarex, a full service pharmaceutical product development company based in Germantown, MD. His key expertise is in training of IT personnel in FDA-regulated industry, creating, managing and implementing Part 11 compliant computer systems. Since 2005, Mr. Wong has been evaluating EDC systems for Part 11 compliance at small and big organizations including some of the largest US federal organizations and large pharmaceutical companies.

FDA's New UDI Labeling Requirements

Scheduled On : Wednesday, April 9, 2014 at 1 PM EDT | 10 AM PDT

Duration : 90 Minutes

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Description : 

The U.S. FDA has just published their long-anticipated Unique Device Identification System Final Rule, on September 23, 2013. It's purpose is to "establish a system to adequately identify devices through distribution and use."  It requires the development of a unique device identifier (UDI) in plain text and machine readable formats, to be part of the labeling of every medical device. There is an 4+ year phase in depending upon the risk / class of the device. In addition, the four key steps to compliance by device manufacturers will be addressed. The Final Rule also has provisions to address existing FG inventory, not properly labeled.

The FDA intends for the UDI to facilitate improve device visibility through distribution to patient use, to aid in adverse events reporting, resolution and trending, commonality of nomenclature in clinical information systems, registries, electronic health records, and similar.

This is a major change for medical device manufacturers, with far-reaching effects in regulatory compliance, as envisioned by the FDA.  Our instructor, John E. Lincoln has also just completed an article on UDI to be published in an upcoming journal article.

Areas Covered in the Session :

This Final Rule focuses on two core elements, as will this webinar (in-depth)

• The UDI code, consisting of the DI, device identifier, and the PI, production identifiers (UDI = DI + PI), types of acceptable formats, and its use on device labeling
• The FDA-administered Global Unique Device Identification Database (GUDID)

Who Will Benefit: 

This webinar will provide valuable information to all regulated medical device companies that are or anticipate selling devices in the U.S. Its principles apply to Personnel / Companies primarily in the Medical Devices fields. The employees who will benefit include:

• Senior management
• Middle management
• R&D
• Engineering
• Software
• QA / RA
• Manufacturing
• Operators
• Consultants
• CGMP instructors
• Device Design Team
• Device Development Team
• Device Manufacturing Team
• Verification and/or Validation planning, execution and documentation for devices.

Speaker Profile

John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.

How to Qualify to Participate in FDA's Secure Supply Chain Pilot Program

U.S. FDA initiates the Secure Supply Chain Pilot Program to enhance security of imported drugs.

Thirteen prequalified companies have now been designated to take part, and will receive expedited entry for the importation of up to five selected drug products into the United States.

The goal of the program is to enable the FDA to evaluate resource savings that will allow the agency to focus imports surveillance resources on preventing the entry of high-risk drugs that are the most likely to compromise the quality and safety of the U.S. drug supply.

It is believed that by creating incentives for manufacturers to adopt best practices for supply chain integrity, FDA can enhance the quality and safety of imported drugs. The program also allows the FDA to focus resources on the areas with the greatest potential risk to consumers.

During these next two years, the FDA will evaluate the program’s effectiveness at enhancing imported drug compliance with FDA regulations and the security of the drug supply chain. If the FDA determines the program to be effective, a more permanent program may be established and possibly extended to additional participating companies.

The 13 prequalified companies accepted into the program that will receive expedited entry, are the following:

1. AbbVie Inc. 
2. Allergan, Inc.
3. Astellas U.S. Technologies, Inc.
4. Bristol-Myers Squibb Company
5. Celgene Corporation 
6. GE Healthcare Inc.
7. GlaxoSmithKline LLC
8. Merck Sharp & Dohme Corporation 
9. Mylan Pharmaceuticals Inc.
10. Novartis Pharmaceuticals Corporation 
11. Pfizer, Inc.
12. Teva Pharmaceutcials USA, Inc.
13. Watson Laboratories, Inc.

What were the Conditions that the above companies met to qualify to participate in FDA's Secure Supply Chain Pilot Program ?

• Commitment  to comply with requirements of the Food, Drug, and Cosmetics Act (FDCA)
• Have a validated secure supply chain protocol per the U.S. Customs and Border Protection’s Customs-Trade Partnership Against Terrorism (C-TPAT) program
• Have a plan in place to quickly correct potential problems the FDA identifies regarding importation of specific products
• Have an effective recall and corrective action plans in place
• Maintain control over their drugs from the time of manufacture abroad through entry into the United States

Source : FDA

For more updates and trainings on FDA Compliance, logon to Compliance Trainings

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Compliance Update : FDA and European Medicines Agency strengthen collaboration in Pharmacovigilance area

The U.S. Food and Drug Administration and the European Medicines Agency (EMA) have set-up a new 'cluster' on pharmacovigilance (medicine safety) topics. Clusters are regular collaborative meetings between the EMA and regulators outside of the European Union, which focus on specific topic areas that have been identified as requiring an intensified exchange of information and collaboration. Building on the experience of previous regular videoconferences between the FDA and the EMA in this area and on the recent creation of the EMA’s Pharmacovigilance Risk Assessment Committee, this cluster will provide a forum for a more systematic and focused exchange of information on the safety of medicines.

The FDA and the EMA have already set-up such clusters to discuss issues related to biosimilars, medicines to treat cancer, orphan medicines, medicines for children, blood-based products, among other topics. Health Canada and the Japanese Pharmaceuticals and Medical Devices Agency are also involved in some of these clusters.

As part of the new cluster, discussions on shared pharmacovigilance issues will now take place between the agencies on a monthly basis by teleconference. This increased degree of interaction will allow the agencies to work swiftly in the area of the safety of medicines and to coordinate communication activities. The creation of this cluster is the latest step in the FDA’s and the EMA’s broader approach to expand and reinforce international collaboration.

This type of collaborative effort is important for ensuring the safety and quality of medicines distributed to consumers throughout the globe. The new cluster will help medicines’ regulators harmonize efforts to keep medicines safe, regardless of location.

Canadian and Japanese regulatory authorities will participate in the meetings of the cluster on pharmacovigilance as observers. The information exchange is covered by confidentiality arrangements between the FDA and the other participants.

Source : FDA

For more updates and trainings on FDA Compliance, logon to Compliance Trainings

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FDA’s 21 CFR Part 11 Add-on Inspections

Scheduled On : Thursday, February 27, 2014 at 1 PM EST | 10 AM PST

Duration : 120 Minutes

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Description : 

In December 2010 the FDA began a project to better understand the industry’s adherence (or lack thereof) to 21 CFR Part 11. This involves the add on’ surveillance inspections of the sponsors’ computer systems during the course of the FDA’s regular inspections.

This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003.

In the meantime FDA officials reported about key findings. For example, George Smith who heads up FDA's Part 11 working group gave an update with examples of violations. This webinar will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome.

Areas Covered in the Session :

• What is FDA's most current thinking related to computers and electronic records?
• What are the inspection trends?
• What are most frequent recent citations for Part11?
• What are the most frequent deviations for computer system validation?
• Under which circumstances can inspectors exercise enforcement discretion?
• How important is risk based Part11 compliance?
• What is the best strategy for future proven Part 11 compliance?

Who Will Benefit: 

• Quality Managers
• Quality Engineers
• Small business owners
• GxP
• Regulatory Affairs professionals
• Consultants
• Quality VPs
• IT VPs
• Regulatory VP
• CEOs

Speaker Profile

Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. “Your Passport to Compliance”. She has 30 years of experience in the Life sciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance. Ms. Bazigos is the president of PRCSQA (Pacific Regional Chapter of the Society of Quality Assurance) a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), ASQ, DIA and RAPS and consults to Pharma / Biotech / Medical Device companies as well as investment groups on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA. She teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and Project Management both to investor groups and industry. More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She is on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and on the Stanford Who’s Who Registry for contributions to the Life science industry

Due-diligence and Gap Analysis in Decision Making Process for Medical Companies

Scheduled On : Wednesday, February 26, 2014 at 1 PM EST | 10 AM PST

Duration : 60 Minutes

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Description : 

In this seminar, we will discuss practical decision making steps you can follow to analyze whether to transfer or invest in keeping production in-house from a successful case study.  If it is decided to transfer production what are the options and next steps to transferring it to the right facility or contract manufacturer (CMO).

With the economy, many medical OEMs are deciding whether to invest in upgrading equipment, technology, new personnel, transfer it to a lower cost in-house facility or transfer it to a contract manufacturer.  In many cases this could save the OEM from investing in costly bricks and mortar, new technology and higher labor cost. It also frees up cash and floor space for new product initiatives. This webinar will give you the steps to follow in making decisions that could save money, time and people.  We will explore the importance of quality, cost and on time delivery/flexibility in making the right decisions.

CMO’s have to be ready for a seamless transfer of production by understanding their responsibility and the requirements for a medical device transfer, including the transfer process, validations and the pitfalls that could lead to delays.

Areas Covered in the Session :

• Gap Analysis, Due-diligence and Decision Making 
• Choosing A Contract Manufacturer
• Request for Information (RFI), Request for Proposal (RFP), Request for Quote (RFQ)
• Supplier Audits
• Final Selection & Contract Negotiation
• Project Management
• Supply Chain/Inventory
• Master Validation Plan
• Protocols/Validations
• Transfer Process to an in-house facility or Contract Manufacturer
• Benefits
• Pitfalls
• Post Review/Lessons Learned

Who Will Benefit: 

This webinar will provide valuable assistance and give a procedure to the medical device industry that is thinking of transferring production to a Contract Manufacturer or transferring it to another facility. The personnel who will benefit include:

• Medical Device OEM’s
• OEM and Contract Manufacturing (CMO) Senior Management
• Decision Makers in regulated industries
• R&D and Product Development Engineers and Managers
• Business Development
• Pilot Plant Manager
• Operations Managers
• Plant and Production Managers
• Project and Process Engineers
• Supply Chain Managers
• Global Contract Manufacturing Transfer Teams
• Global Strategic Managers
• Quality and Validation Teams
• Quality and Corporate Auditors
• Contract Manufacturers
• Decision Makers in regulated industries
• Business Development
• Contract Manufacturers
• Plant and Production Managers
• Operation Managers
• Engineering and Contract Manufacturing Transfer Teams
• Project Management Teams
• Project and Process Engineers
• Quality and Validation Teams

Speaker Profile

Robert Braido has 40 years of experience in the medical industry. He is president of Visionary Consulting LLC and has been consulting with medical OEM’s and CMOs for over 7 years. Mr. Braido’s has a broad breadth of medical industry experience in prototype/product development, global strategic/tactical planning, technical due-diligence/gap analysis for acquisitions, engineering, operations and business development. He has had great success working at Ethicon Endo-Surgery a J&J Company, Baxter Healthcare, Teleflex Medical, GW Plastics and The Tech Group with increasing responsibilities to the level of VP of Advanced Technologies. He was a member of the Board of Directors for the Society of Plastic Engineers Medical Division for over 10 years and elected Chairman of the Medical Division twice.

Mr. Braido was selected as a member of a Johnson & Johnson Integration Team that took a small fledgling endoscopic medical device company with totally new products, technologies and structure from $75 million to $850 million in 5 years. His career is built on the ability to motivate, lead and coach people in different disciplines throughout the medical industry. The key factor has been driving innovation.

Mr. Braido was elected, as the Consortium Chairman for the Government Reinvestment Program with MIT, the National Science Foundation and seven leading Fortune 200 companies to commercialize 3D Printing and emerging technologies in plastics and metal. He represented J&J as the principal investigator in the development of 3D Printing with the consortium. He has also been an independent reviewer for the National Science Foundation, J&J, MIT, EdgeOne Medical and others.

He has published numerous technical and leadership articles and white papers. In the past he has shared his extensive experiences at seminars, workshops, technical conferences, symposiums and webinars on subjects relating to the medical and plastics industries on due-diligence/gap analysis, product development, plastic and metal manufacturing, plastic product and equipment transfers, compliance, leadership and developing an innovation culture.

Key Regulatory Documents: DHF, DMR, DHR and Technical File (TF) & Design Dossier

Scheduled On : Wednesday, February 26, 2014 at 1 PM EST | 10 AM PST

Duration : 90 Minutes

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Description : 

There are key regulatory documents global medical device companies must meet for the U.S. and the European Union / Common Market.  And there are important differences. The cGMPs mandate Design Control and proof of compliance in 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 there are some similarities.  And both are moving together in some important areas.  Being aware of the similarities and differences can further concurrent development / documentation, and/or updates to both.

What are DMRs and DHRs relationship to DHFs, TF/DDs?

This 90 minute webinar will examine the existing and proposed requirements for the U.S. FDA's DHF and the EU MDD's TF/DD. This webinar will provide valuable assistance to all regulated device companies that need to ensure their DHFs, TFs/DDs and associated and derivative documentation meet their respective requirements. It also addresses current requirements as well as some changes on the horizon.

Areas Covered in the Session :

• How to meet and document their differing requirements.
• Required and desirable contents.
• Areas requiring frequent re-evaluation / update.
• Similarities and differences, and future convergences and trends.
• Typical DHF contents.
• Typical Technical File or Design Dossier 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.
• Where the Device Master Record / Device History Record "tie in".
• Differing approaches to records audits by the U.S. FDA and an EU Notified Body.

Who Will Benefit: 

This webinar will provide valuable assistance to all regulated device companies that need to ensure their DHFs, TFs/DDs and associated and derivative documentation meet their respective requirements. Its principles apply to personnel / companies in the Medical Devices,  Diagnostic, and to a lesser extent the Pharmaceutical and Biologics fields. The employees who will benefit include:

• Senior management
• Middle management
• R&D
• Engineering
• Software
• QA / RA
• Manufacturing
• Operations
• Consultants
• cGMP instructors
• All personnel especially involved in device development, regulatory compliance and documentation. 

Speaker Profile

John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.

FDA Electronic Regulatory Filings Submission – Drug Establishment Registrations and Drug Listings

Scheduled On : Tuesday, February 25, 2014 at 1 PM EST | 10 AM PST

Duration : 60 Minutes

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Description : 

FDA gives a number of reasons for the decision to move away from paper submissions. These include: electronic review of drug labels for compliance, elimination of data entry errors, and creation of a more efficient and effective process. If you keep in mind that the Gateway can be accessed 24 hours a day, there is the added benefit that properly-created SPL files can theoretically be processed in minutes.

To facilitate the submission of drug establishment registration and drug listing information (including labeling), FDA adopted the use of Extensible Markup Language (XML) files in the Structured Product Labeling (SPL) format. SPL is based on the Health Level Seven (HL7) version 3 Reference Information Model (RIM) and the Clinical Document Architecture (CDA). Additionally, code sets and codes are used to assist with processing, reviewing, and archiving electronic submissions. The necessary submissions to remain compliant include an Establishment Registration SPL, an NDC Labeler Code Request SPL and a Drug Listing SPL. Once the SPL file is created, it can then be submitted (uploaded) to the ESG. This includes digital certification since the submission is a secure one.

Even with the stated benefits, the electronic submissions process is arduous.  SPL creation is but one hurdle to overcome. FDA actually encourages owners and operators subject to registration and listing to establish accounts (granting access to the ESG) 4-6 weeks in advance of the time to register, list, or update a registration or listing. Having knowledge of the electronic process will best ensure you’re your submissions are not delayed!

US Food and Drug Administration (FDA) now requires electronic submission for labeler code requests, drug establishment registrations, drug listings, annual renewals, and updates. The electronic process replaces FDA paper forms 2656 (Registration of Drug Establishment/Labeler Code Assignment), 2657 (Drug Product Listing), and 2658 (Registered Establishments’ Report of Private Label Distributors). To transmit files, companies must use the FDA’s Electronic Submission Gateway (ESG). According to FDA, moving from a paper-based format to an electronic system has improved the timeliness and accuracy of submissions.

This webinar will provide clarification and guidance on the process of submitting drug establishment registration and drug listing information to the FDA.

Areas Covered in the Session :

• Overview of FDA drug establishment and listing requirement
• Transition from paper-based to electronic process
• Creation of electronic files
• Extensible Markup Language (XML)
• Structured Product Labeling (SPL)
• Codes and code sets
• Establishing FDA Gateway (ESG) account
• Submission to ESG
• Checking drug establishment registration and listing status

Who Will Benefit: 

• Regulatory Affairs professionals
• Project Managers
• QA & QC Managers
• Prescription Drug manufacturers
• Over-the-counter (OTC) Drug manufacturers
• Active pharmaceutical ingredient (API) Drug manufacturers
• Homeopathic Drug manufacturers
• Medical Gas Drug manufacturers
• Consultants
• Any individuals interested in the drug industry

Speaker Profile

Camille Davis Thornton, M.S., RAC is the founder of MACE Concepts, LLC, an independent consultancy specializing in providing innovative regulatory, compliance, and training solutions. Ms. Thornton has an M.S. in Biotechnology from The Johns Hopkins University and certifications from the Regulatory Affairs Professionals Society (RAC-US) and the National Restaurant Association (ServSafe® Food Protection Manager, Instructor, and registered Examination Proctor). Additionally, she has over 15 years of experience in multiple regulated industries and actively teaches at the college level.

Ms. Thornton's areas of expertise include regulatory filings, the FDA Electronic Submissions Gateway (ESG), and liaising with government agencies. Also known as the “Perpetual Inquisitive Geek”, she regularly reviews applicable guidance documents, notifications, newsletters, blog postings, and email alerts from various government agencies to stay up-to-date with current requirements and industry trends. Ms. Thornton is a regulatory affairs professional and trainer with a true passion for sharing knowledge effectively.