Avoid Workplace Litigation and Non-Compliance Fines: Conduct an HR Audit

Scheduled On : Thursday, February 20, 2014 at 1 PM EST | 10 AM PST

Duration : 60 Minutes

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Description : 

It only takes one disgruntled employee to file a complaint of unfair labor practices to incite a full blown investigation by the IRS, DOL, EEOC, ect. These investigations can interrupt you business as well as be time-consuming and very expensive. Are you prepared? By conducting your own HR Audit, you may avoid litigation and non-compliance fines. An HR Audit can also provide an objective look at the company’s human resources policies, practices, procedures, programs, and strategies to help not only protect the company from litigation and fines; it can establish best practices, identify opportunities for improvement, and evaluate outsourcing options. HR Audits can ensure effective utilization of HR resources and improve customer service, which in turn can increase revenue.

HR Audits can help the company become more efficient as well as save money, reduce productivity time, and cut costs. HR Audits can also help companies avoid non-compliance fees and government audits/intervention, such as Wage and Hour, EEOC, Unemployment, Workers Compensation, Immigration Services, Lawyers, etc.

Areas Covered in the Session :

• What is an HR Audit
• When to Conduct an HR Audit
• Who should conduct the HR Audit
• How to Conduct an HR Audit
• Step-by-Step Sample Audit of Healthcare Company, Including Report Out and Action Plan

Who Will Benefit: 

This is a must attend training for everybody involved in HR Auditing, including: 

• Business Owners
• HR Managers
• HR Representatives
• HR Generalists
• HR Assistants
• Consultants
• Managers
• Supervisors

Speaker Profile

Vanessa G. Nelson, MSA, SPHR, CLRL is founder and President of award-winning Expert Human Resources, which she founded to help companies maintain legal compliance, avoid workplace litigation, reduce costs, increase revenue and competitiveness.

Vanessa established Expert Human Resources in 2009, after observing companies' frustrations with complying with constantly changing employment laws as well as continually dealing with workplace litigations and fines. Vanessa realized that a lot of the litigious situations that businesses encountered could be avoided by their being proactive and implementing updated polices and applying them correctly. Vanessa also recognized that many companies could not afford a full-time HR person, or department, to assist in maintaining compliance with employment laws, as well as applying policies and practices correctly; therefore she established a "portable HR" to accommodate those businesses.

Vanessa is a results-oriented HR Consultant with a unique background in business management, spanning over 29 years at Hurley Medical Center and Sparrow Health Systems. Her expertise includes: HR audits, labor relations, employment laws, employee relations, workplace investigations, and policies and procedures. Additionally, Ms. Nelson has implemented processes to improve conflict management and employee relations; conducted harassment training to improve company efficiencies, worked with multiple unions to produce positive outcomes, and has recruited dozens of talented employees. She is mobile and able to quickly interpret and apply policies fairly and consistently.

Ms. Nelson received her Master of Science in Administration/Human Resources Management from Central Michigan University, and a Bachelor in Business Management from Northwood University. She holds the Certified Senior Professional in Human Resources (SPHR) credential from Human Resources Certification Institute, Certified Labor Relations Leader (CLRL) from Michigan State University, and is Six Sigma White Belt certified.

Vanessa has conducted multiple seminars including: Lawsuits Waiting to Happen, Human Resources and Employment Law Updates, How to Conduct Effective Investigations, and FMLA.

Cyber Security Planning for Medical Devices

Scheduled On : Thursday, February 20, 2014 at 1 PM EST | 10 AM PST

Duration : 60 Minutes

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Description : 

How you manage cyber security issues for medical device software raises serious concerns at FDA. Software is subject to a number of FDA requirements, such as the Quality System Regulation design control requirements. In adequate cyber security measures can lead to a risk to health that prompts other regulatory requirements, such as Medical Device Reports, Reports of Corrections and Removals and potentially to premarket requirements where the redesign of cyber security software results in a significant change to a device. There is an open question about whether any correction of software should be reported to the FDA. The webinar will integrate these issues so you can understand the need for cyber security and develop a comprehensive plan to manage the real possibility of a fatal hack attack.

Cyber Security issues address software vulnerabilities. Exploiting software vulnerabilities, such as with “hacking,” can lead to devastating results. In terms of medical devices, malicious hacking can lead to serious injury or death. When FDA began to regulate medical devices, software had not evolved to a level of pervasive use, as a stand alone device or as a customized platform for institutional use. Even today, FDA struggles to keep up with the evolution of software, its applications and its inherent risks. There are many instances of how cyber security measures are inadequate for commercial and personal use software. What happens when the software malfunctions or fails to perform is a necessary consideration now. For example, someone in a remote location can cause a life sustaining device to stop working. That ability has been proven. The elements of design, operation and correction of corrupted software require rigorous evaluation. As health care technology and cost management increasingly rely on software, the potential for an increased incidence of adverse events related to hacking will follow.

Areas Covered in the Session :

• FDA Draft Guidance entitled, “Content of Premarket Submissions for Management of Cyber Security in Medical Devices.” 
• FDA Safety Alert entitled, “Cyber Security for Medical Devices and Hospital Networks: FDA Safety Communication
• Device regulatory requirements before and after marketing 
• Risk to health consequences of  Cyber Security failure
• Off-the-Shelf software Cyber Security

Who Will Benefit: 

• Software specification developers and engineers
• Information technology managers
• Regulatory affairs senior managers
• Risk managers for clinical institutions
• Clinical management teams
• Patient managers for life supporting/life sustaining devices
• Crisis intervention planners
• Customer training managers
• Manufacturers with a history of software recalls
• Devices Manufacturers that use software
• FDA device consultants
• Third party software designers / engineers
• Clinical institutions
• Entire staff of a start up device manufacturing firms

Speaker Profile

Casper Uldriks held a number of positions at FDA, such as an investigator in FDA's New England office, in the Office of the Commissioner in Legislative Affairs and in the Center for Devices and Radiological Health (CDRH), where he served as CDRH's Associate Director for Regulatory Guidance and Government Affairs. He helped to guide CDRH to develop and implement various medical device related amendments to the Food, Drug, and Cosmetic Act, regulations and guidance documents. For years he has trained FDA staff on medical law and has been a featured speaker at many professional conferences involving FDA's medical device program. He is “of counsel” at Olsson Frank Weeda (OFWLAW) in Washington, DC and licensed to practice in Massachusetts and the District of Columbia.

Compliance Update : How does FDA Evaluate The Regulated Drugs ?

The Food and Drug Administration’s Strategic Action Plan for Risk Communication is an initiative to tell consumers how the agency makes decisions on the safety and effectiveness of FDA-regulated products. This is the first in a series of articles about the data and methods—and their limitations—that FDA uses to determine whether products are safe for patients and consumers to use.

This is how the agency’s Center for Drug Evaluation and Research evaluates the safety and effectiveness of drugs.

The Regulation of Drugs
How the Facts Are Collected

• The first step for a company seeking approval to sell a new drug is to perform laboratory and animal tests to learn how the drug works and if it will be safe enough to be tested in humans. The company submits an Investigational New Drug Application (IND) for FDA’s review prior to testing in humans.
• The company performs a series of clinical trials in humans in three phases, which FDA monitors, to test if the drug is effective and safe.
• Next, the company sends its data from all these tests to FDA's Center for Drug Evaluation and Research (CDER) in a New Drug Application (NDA). A team of CDER physicians, statisticians, toxicologists, pharmacologists, chemists and other scientists review the data and proposed labeling.
• If this review establishes that a drug's benefits outweigh its known risks for its proposed use, the drug is approved for sale.
• After the drug is on the market, the FDA monitors its performance in a number of ways. One of those ways is the through MedWatch, the agency’s safety information and adverse event reporting program, which receives reports of suspected adverse reactions (side effects of medicines) from consumers, health care practitioners and pharmaceutical companies. And the agency has access to databases that collect information on prescription drug use and health outcomes. These data help FDA staff identify and understand side effects of medicines.
• If an unexpected drug-related health risk is detected, a Drug Safety Communication may be issued to consumers and healthcare professionals. A statement is added to the drug label about the new safety concern to ensure continued safe and effective use of the drug. Occasionally, approved drugs may be withdrawn from the market for serious safety risks if it is determined that the overall risks outweigh any benefits the drug may provide.

The Limitations of Safety Data

• FDA provides guidance to companies during the various phases of the human clinical trials. Even so, the number of people in a clinical trial of a new drug is usually small in comparison to the number of people who may take the drug if it reaches the market. This makes it difficult to detect rare side effects.
• Even though data from human trials are analyzed by a team of experts before a drug is approved, it can be impossible to anticipate all bad reactions—especially very rare safety risks—unless they had also happened with use of a similar drug.
• Complicating matters is the fact that after they are approved, drugs are often taken by sick people who are on other medications at the same time, making it difficult to predict how they will react to the drug. And the drug’s effect on the patient may change over the course of years.
• There are hundreds of thousands of adverse events reported via MedWatch each year, but this reporting system is voluntary and there are serious drug reactions that are never reported.
• Because the nation’s healthcare system is not integrated, there is no standard way to track the adverse effects of a medicine in any given health system or across different health systems. Health insurance databases can be helpful in this regard, but they are only accurate as long as a patient has the same job and is enrolled with the same insurance system since many people are insured through their employer. This limits FDA’s ability to monitor the safety of medications taken over many years.  However, FDA, through its Sentinel Initiative, is currently working to develop capabilities to use data from different health systems to better understand the safety of drugs in clinical practice.

Ultimately, FDA faces a balancing act in evaluating a new drug. If it’s good for one person or a small group, will it be good for the whole population?  Which safety risks are likely to be acceptable to patients who might take a drug and physicians who might prescribe it? Once a drug is marketed and new information about its safety becomes available, FDA must revisit these questions continually over the drug’s lifecycle.

In the end, no matter how much data are available, we often have to make a judgment call, weighing the known benefits against known risks and the potential—and possibly unknown—risks.

Source: FDA
For more updates on FDA and Compliance Trainings, logon to www.compliancetrainings.com

  

Improved Generic Drugs via the 505(b)(2) Regulatory Pathway: FDA Approval Made Easy

Scheduled On : Wednesday, February 19, 2014 at 1 PM EST | 10 AM PST

Duration : 60 Minutes

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Description : 

A 505(b)(2) product is an improved or altered version or a new use application for a previously FDA-approved drug. This unique regulatory pathway, available only for marketing approval in the US, offers an attractive pathway to cheaper and faster new drug development, particularly to a manufacturer with experience in developing generic products. It involves making significant changes to an existing FDA approved product, called reference product, to create a new product with its own indication, formulation, population, and/or other differences that need to be supported with clinical studies. A major advantage of this pathway is that it allows a sponsor to rely, at least in part, on the FDA’s findings of safety and/or effectiveness for a previously approved drug, thereby reducing the number of clinical trials required for approval. The biggest incentive to develop 505(b)(2) products is 3 years of market exclusivity available to the approved product.

Despite being around for more than 25 years, same as generic drugs, the 505(b)(2) products have only recently become more popular. The main reason is that due to several similarities with generic products, 505(b)(2) products offer some unique challenges. Just like NDAs for new drugs, 505(b)(2) products are subject to full user fee under the Prescription Drug User Fee Act (PDUFA), could require several clinical and non-clinical studies and could take a significant allocation of resources, albeit less than that for a brand new product but much higher than that for a generic drug. Like all drug development strategies, 505(b)(2) pathway requires careful consideration and planning taking into account all the potential issues to be addressed before embarking on development.

This pathway is particularly attractive to manufacturers transitioning from generic drugs to innovator products. Due to the similarities with traditional drug development, they offer a low risk market entry point by training the work force in the traditional development processes. However, as would be evident, there are unique challenges to developing such products – scientific, regulatory, logistical and financial – all of which could convert a potentially attractive project into a constant headache.

This seminar will discuss the practical strategies for drug development via 505(b)(2) regulatory pathway. Key strategic considerations will be discussed using real-life case studies. Also discussed will be role of interactions with the FDA, global clinical trials, market access, reimbursement issues and projected trends for the near future. Lastly, the 505(b)(2) pathway will be compared to that for biosimilars.

At the end of the seminar, the attendees will be familiar with the following: 

• FDA guidance on 505(b)(2) products
• Gap analysis and IND strategy for new formulations of previously FDA-approved drugs
• Meeting with FDA to discuss 505(b)(2) submissions
• Trends in FDA review of INDs and NDAs for 505(b)(2) products 
• Do’s and Don’ts for development plans for 505(b)(2) products

Areas Covered in the Session :

• The 505(B)(2) regulation and guidance from the FDA
• Strategic considerations before embarking on a 505(b)(2) development project
• Intellectual property issues with such products
• Key development steps for such products
• FDA’s review process and ongoing consultation
• Challenges to developing 505(b)(2) product and possible solutions
• Examples of successful strategies for developing such products
• Searching for a 505(b)(2) project, future trends
• 505(b)(2) and biosimilars

Who Will Benefit: 

The following individuals or disciplines will benefit from attending this Webinar: 

• Regulatory affairs professionals
• Senior management executives (CEO, COO, CFO, etc)
• Drug discovery and development professionals (R&D and CMC)
• Intellectual property experts
• Project Managers and Clinical trial specialists
• Regulatory Compliance Associates and Managers
• People investing in FDA-regulated product development projects

Speaker Profile

Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He and leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD. His key expertise is in regulatory affairs, clinical trials and multinational project management for medicinal and diagnostic products. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe and Asia. He has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. Dr. Kumar is a PhD in Biochemistry and has worked as a research scientist at the NIH, Baylor College of Medicine, Houston, and premier institutions in India. He is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.

21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration

Scheduled On : Wednesday, February 19, 2014 at 1 PM EST | 10 AM PST

Duration : 60 Minutes

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Description : 

All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records.

Medical device manufacturing plants, required to follow 21 CFR Part 820, have the additional responsibility to ensure that each and every step of the manufacturing process is controlled by work instructions, SOPs, set-up instructions, equipment maintenance, and support functions, and that evidence of this work is maintained by controlled records.

Prior to computer systems and databases, managers and quality personnel created complex visual numbering schemes, cross-referencing methods and complex filing systems for purposes of retrieval and control.  These grew over the years into the extremely complex and convoluted systems we find today throughout the life sciences, including the medical device industry.

As is often the case, automation and computers do not always replace the legacy methods, policies, and rules that were necessary with manual and paper systems but are now obsolete.

Unfortunately, that is the case in the overwhelming majority of medical device companies.  The benefits of automation and information retrieval systems are not fully realized due to the legacy policy constraints that still hamper them.

If you are constantly struggling to create, manage, and maintain all of the information found in controlled documents, all of which are often redundant, repetitive, and clustered together in an awkward manner, this webinar is something that will give you a different perspective and a very different approach that you can use.

If your design and manufacturing resources are spending too much time on documentation and not enough time on actual design and manufacturing you as a manager need to be looking for ways to simplify their work.

In this webinar, we apply the Theory of Lean documents and its corollary Theory of Lean Configuration to present a fresh approach to following 21 CFR Part 820, yet is based on solid principles and proven
practices.

Areas Covered in the Session :

• Brief introduction to Lean Documents and Lean Configuration
• Quality System Regulation, 21 CFR Part 820, and ISO 13485 as these apply to design control documents
• Basic functions found in a life sciences manufacturing plant
• Key types of controlled documents and records for manufacturing
• Quality Management System (QMS) elements controlled via documentation
• Bringing it all together

Who Will Benefit: 

All Managers, Supervisors, Directors, and Vice-Presidents in the areas of: 

• R&D
• Design Assurance
• Quality Assurance
• Operations
• Document Control
• Manufacturing Engineering

Speaker Profile

José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment. José led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, kanban systems, visual workplace and lean manufacturing practices. José worked for 10 years at Cordis Corporation, now a Johnson & Johnson company, where he led the successful tooling, process development and qualification of Cordis’ first PTA (percutaneous transluminal angioplasty) catheter. His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopaedic implants and instruments, and vascular surgery grafts and textiles. During his time at Cordis, José managed the Maintenance and Facilities Department, taking that operation to a level rated as “tops” by the UK Department of Health and Social Services (DHSS) during one of their intensive audits. Jose managed Manufacturing Engineering as part of the Guiding Catheter Core Team of managers, a team that took the Cordis Guiding Catheter business to lead the market, bringing it up from fourth place. By introducing world-class techniques, the Guiding Catheter design and manufacturing was completely re-engineered for robust design and tooling, under Jose’s leadership. He was also instrumental and played a leadership role in the complete re-engineering of the Tooling Control System, including design drafting, the tool shop and technical support. Wherever he has worked, he has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches.

Dealing with Conduct Problems: From the Manipulative to the Mentally ill

Scheduled On : Thursday, February 13, 2014 at 1 PM EST | 10 AM PST

Duration : 90 Minutes

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Description : 

This work place misconduct webinar training will help you deal with some of the most complex employee relations issues in today’s workplace, from FMLA abuse to workplace violence to the ADA implications of mental illness, how to do internal moral investigations, terminate potentially dangerous employees, how to handle workplace bullying.

When an employee behaves inappropriately in the work place, he/ she may be charged by the employer depending upon the severity of the misconduct. Minor misconduct often involves a lesser punishment while a gross misconduct may result in termination of the employee contract with the employer. Minor misconduct is the actions that are unacceptable but not criminal such as poor task performance, excessive absence and safety violations. Gross misconduct in the work place leads to serious actions that can even result in the employee’s dismissal.

Misconduct has a negative effect on the organization and the employee involved. Discipline at the work place is the means by which you can correct the behavioral deficiencies. The purpose of the discipline should be to correct the behavior rather than punishing the employee.

An employer must set appropriate disciplinary rules and procedures which explain the standards of conduct at work. The HR department has a responsibility to ensure that the employees maintain high standards of conduct and performance. All employees with unsatisfactory performance or misconduct should be observed confidentially and proper steps should be taken in every stage to secure documentation. There should be a written disciplinary procedure and good disciplinary actions will help the employer to take appropriate steps in the event of misconduct of an employee.

This work place misconduct webinar training will help you deal with some of the most complex employee relations issues in today’s workplace, from FMLA abuse to workplace violence to the ADA implications of mental illness, how to do internal moral investigations, terminate potentially dangerous employees, how to handle workplace bullying.

As employees’ legal rights expand, so does the opportunity for abuse. On the one hand, employers often feel paralyzed to investigate – or discipline – employee misconduct for fear of potential litigation; on the other, managers may jump in the gun and fail to recognize the legal issues involved before taking corrective action.

Managers spend 57% of their time putting out fires started by problem employees. And yet, these are not the employees who contribute to the bottom line, enhance workplace morale, or facilitate good work relationships. Human resource professionals can play a vital role in shifting this balance, by preventing, and correcting, potential leave abuse, teaching managers how to deal with threatening, insubordinate, or mentally ill employees, and serving as a consultant in difficult disciplinary or termination decisions.

This course will teach you legal and interpersonal strategies to deal with your worst employee relations nightmare.

Areas Covered in the Session :

• How to prevent, identify, and remedy FMLA abuse
• How to respond to verbal threats and insubordination
• Strategies for dealing with an employee's arrest
• Recognizing, and responding to, personality disorders in the workplace
• How to terminate a potentially dangerous employee
• When, and how, to conduct a morale investigation
• Tackling psychiatric disabilities and substance abuse in the workplace
• How to handle the workplace bully

Who Will Benefit: 

• Senior HR Professionals
• HR Analysts
• HR Mangers & Directors
• HR Personnel
• Managers & Supervisors
• Employee Relations Professionals
• Line managers
• Directors, Vice Presidents & Managers of Recruiting/Retention
• Directors, Vice Presidents & Managers of Human Resources
• Employment Managers/Specialists
• HR Coordinators/Supervisors

Speaker Profile

Dr. Joni E. Johnston, is the founder and CEO of Work Relationships, a corporate training and consulting company specializing in workplace mental health problems as well as employee conduct issues including workplace harassment, workplace violence, and effective discipline/termination. Dr. Johnston has been performing human resource seminars for professional groups and industry associations since she founded her HR/employee relations consulting and training firm in 1991, and has personally trained over 50,000 managers and supervisors. She has worked extensively in the biotech and life sciences industry. A forensic psychologist, Dr. Johnston has written monthly columns for LexisNexis, HR.Com and HRGateway. She is an adjunct professor in Tiffin University's criminal justice program and has authored three books, including The Complete Idiot's Guide to Psychology. She has also served as an expert witness in numerous employment-related lawsuits.

Medical Device Changes and the 510(k)

Scheduled On : Wednesday, February 12, 2014 at 1 PM EST | 10 AM PST

Duration : 60 Minutes

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Description : 

This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k). 
Consideration of the U.S . FDA's current K-97-1 Memo / guidance document on "510(k) Device Modifications"

Control of medical device changes and a current 510(k) are big issues in recent FDA studies. Companies are held fully responsible for deciding when a new 510(k) filing is warranted. Often this is a difficult decision process. Effective change control and the power of current risk management tools must be a major part of such an analysis. The U.S. FDA has its current K-97-1 Memorandum (they recently pulled their proposed new draft Guidance Document, "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device"). K97-1 provides a tool to assist in device and new 510(k) / change analysis. The addition of such simple tools will assist companies in implementing formal, documented, repeatable methods with defensible rationale for their decisions on when changes trigger the need for a new 510(k) submission.

The K97-1 analysis is the preferable tool to work with a company's change control system to document the need to file, or the rationale for not submitting a 510(k). It is recommended as the preferred method for documentation of each change in a device during its lifecycle.  Provides for a Step-by-step analysis: Manufacturing, Labeling, Tech / Performance, and/or Materials Changes. Consideration of which of the three major 510(k) formats should be used: Traditional, Special or Abbreviated.

Areas Covered in the Session :

This webinar will provide valuable assistance to all regulated companies performing and documenting meaningful, results driven 510(k) / change analysis activities, based on the FDA's current Guidance on 510(k) Device Modifications. This session will cover:

• Deciding When to Submit a 510(k) for a Change to an Existing Device, K97-1
• How to provide tools to document such decisions
• It will discuss how companies can best document their decisions -- whether or not a new 510(k) filing is warranted
• How to structure a decision matrix to document change decisions
• How to evaluate changes that could trigger the "Tipping Point"
• Who makes the decisions and how to defend them
• How to implement formal methods with documented, and defensible rationale
• Preparing for further 510(k) changes in the future

Who Will Benefit: 

This webinar is a must for companies in the Medical Device and combination products fields. The employees who will benefit include: 

• Research & Development
• Engineering Staff
• Quality Assurance
• Regulatory Affairs
• Lean & Six Sigma staff
• New Product Development
• Marketing
• Mid-level and Senior Management
• Project Leaders
• Consultants

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.