2-day In-person Seminar on Effective Complaint Handling, Medical Device Reporting and Recalls
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. Trending is the only way a company can stay on top of emerging quality issues and address those that are most pressing.

Medical Device Reporting (MDR) is the mechanism for FDA to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. User Facilities (e.g., hospitals, nursing homes) are required to report suspected medical device related deaths to both the FDA and the manufacturers. User facilities report medical device related serious injuries only to the manufacturer. If the medical device manufacturer is unknown, the serious injury is reported by the facility to FDA. Health professionals within a user-facility should familiarize themselves with their institution procedures for reporting adverse events to the FDA.

The MDR process impacts device user facilities, manufacturers, importers, and distributors. If you are a device user facility, you must report deaths and serious injuries that a device has or may have caused or contributed to, establish and maintain adverse event files, and submit summary annual reports. If you are a manufacturer or importer, you must report deaths and serious injuries that your device has or may have caused or contributed to, you must report certain device malfunctions, and you must establish and maintain adverse event files. If you are a manufacturer, you must also submit specified follow-up.

Recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death. It is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

A medical device recall does not always mean that you must stop using the product or return it to the company. A recall sometimes means that the medical device needs to be checked, adjusted, or fixed. If an implanted device (for example, a pacemaker or an artificial hip) is recalled, it does not always have to be removed. When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place. FDA classifies medical device recalls into three categories, representing the potential risk to public health: Class I, II, and III.

Why you should attend:
• Understand that although FDA does not specify a standard complaint handling system, the requirements do specify certain actions that shall be included in any system
• Grasp and comprehend the definitions and elements of the regulatory requirements for Complaint Handling, Medical Device Reporting and handling of Recalls
• All personnel who deal with customers, or who may receive a complaint call, must be trained in the proper routing/handling of complaints
• Provide information about FDA's Medical Device Reporting (MDR) regulation and the Voluntary Reporting program called MedWatch
• Introduce you Medical Device Reporting and to help you better understand the process and benefits of Voluntary Reporting and responsibilities
• Latest Amendments to the MDR Regulation to Implement FDAMA Changes
• To Recall or Not to Recall: Issues to consider regarding whether a Field Action is required
• Determine when a recall is required and how to manage a recall, who must report, when to report, what to report, where to report, recordkeeping requirements, FDA regulatory authority, references and guidance
• Seminar attendees are encouraged to bring examples of their work from the functional area on the various topics as applicable for group discussion
• Review and discuss pain points, challenges and solutions
Areas Covered in the seminar:
• Reporting complaints
• Managers
• Complaint evaluation and investigation
• Data collection and trending
• CAPA process for investigating complaints
• Accelerate complaints recording, investigation, reporting, escalation/triggers and closure cycle as cases are automatically routed from one stage to the next
• Gain enterprise-wide visibility into the complaints data and track the process with performance metrics, dashboards or other indicators
• Improve communication and teamwork on complaints across departments and functional areas
• Drive continuous improvement by tying corrective actions with complaints for a closed loop quality process
• Improve management of the complaint lifecycle with real-time trending and escalation of customer complaints
• Understand the History of MDR Regulation
• What types of Reports does the FDA receive and who must submit Mandatory Reports to the FDA?
• Who can submit Voluntary Reports to the FDA?
• How Does the FDA Use Medical Device Reports?
• What are the exemptions, variances, or alternative forms of adverse event reporting requirements?
• Basics of a Recall: Initiation, Classification and Public Warning
• Medical Device Recall Reporting
• Recall Responsibilities & Requirements
• FDA's Role
• Introduction to Medical Device Recalls: Industry Responsibilities
• Recall Communication and Strategy
• Monitoring and Auditing Recall Effectiveness
• Recall Termination
• Guidance for Industry, Trends and FDA Inspection & Enforcement Statistics and Trends

Course Description:
Day 1 – Agenda
Lecture 1: Complaint Handling:
Lecture 2: Medical Device Reporting
Lecture 3: Exercise and Recap of Day 1

Day 2 – Agenda
Lecture 4: Medical Device Reporting
Lecture 5: Recalls
Lecture 6: Exercise and Recap of Day 2
Who Will Benefit:
• Regulatory Affairs Management
• Regulatory Affairs Specialist
• Auditors
• Compliance Officer
• Compliance Specialist
• Clinical Affairs
• Quality Assurance Management
• Marketing & Sales
• Distributors/Authorized Representatives
• Legal Counsel
• Engineering/Technical Services
• Operations/Manufacturing
• Consultants

About Speaker - David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses global regulatory requirements.

DATE, VENUE & Price:
1. Location : San Francisco, CA | April 25th & 26th, 2013 (Thursday & Friday) | 9 AM to 6 PM PDT
Venue : Hilton San Francisco Fisherman's Wharf
Price: $1,295.00
Register now and save $200. (Early Bird)
Until March 29, Early Bird Price: $1,295.00
From March 30 to April 23, Regular Price: $1,495.00
2. Location : Boston, MA | July 25th & 26th, 2013 (Thursday & Friday) | 9 AM to 6 PM EDT
Venue : Courtyard Boston Logan Airport
Price: $1,295.00
Register now and save $200. (Early Bird)
Until May 15, Early Bird Price: $1,295.00
From May 16 to July 23, Regular Price: $1,495.00

Contact Information:

Event Coordinator
Toll free: 1800 447 9407
Fax: 302 288 6884
Email: support@globalcompliancepanel.com
Website: https://www.globalcompliancepanel.com
LIVE CHAT SUPPORT ALSO - http://www.globalcompliancepanel.com/chat/client.php

EVENT Link - http://bit.ly/11cTARj

GlobalCompliancePanel
NetZealous LLC
43337 Livermore Common, Fremont CA 94539, USA

2-day In-person Seminar on Software Validation for the New FDA Inspections
Overview:
• This course will teach you how to reduce software validation costs by as much as two thirds.
• It details all the requirements for 21 CFR Part 11 and HIPAA that relate to SOPs, software features, and risk-based validation.
• The course is highly interactive, using real life examples and proven techniques.
• You will learn how to use electronic records and electronic signatures to maximize productivity.
• This course will teach you how to prepare for an audit and is intended for IT, QA, laboratory, clinical, and manufacturing staff, as well as software vendors.
• The instructor starts with the basics and covers advanced concepts such as how to "Right size" change control methods that allows quick and safe system revalidation.
• Learn how to reduce testing time, and how prepare documents that avoid 483s and warning letters.
Course Description:
Day 1 – Agenda
Lecture 1: Introduction to the FDA
Lecture 2: 21 CFR Part 11 - Compliance for Electronic Records and Signatures
Lecture 3: HIPAA Compliance for Electronic Records
Lecture 4: The Five Keys to COTS Computer System Validation
Lecture 5: The Validation Team
Day 2 – Agenda
Lecture 6: Ten-Step Process for COTS Computer System Validation
Lecture 7: How to Write Requirements and Specifications
Lecture 8: How to Conduct a Hazard Analysis/Risk Assessment-Exercise
Lecture 9: Software Testing
Lecture 10: System Change Control
Lecture 11: Cost Reduction Without Increasing Regulatory or Business Risk
Lecture 12: Q & A
Who Will Benefit:
• IT
• QA
• QC
• Laboratory staff
• Managers
• Regulatory Affairs
• GMP, GCP, GLP professionals

About Speaker: David Nettleton is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is Risk Based Software Validation - Ten easy Steps. It relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications.

He specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and project management. He has completed more than 225 mission critical software validation projects.

DATE, VENUE & PRICE:
1. Location : Philadelphia | April 18th & 19th, 2013( Thursday & Friday) | 9 AM to 6 PM EDT
Venue : DoubleTree by Hilton Hotel Philadelphia Center City
Price: $1,295.
Register now and save $200. (Early Bird)
Until March 29, Early Bird Price: $1,295.00
from March 30 to April 16, Regular Price: $1,495.00
2. Location : San Diego | September 19th & 20th, 2013 (Thursday & Friday) | 9 AM to 6 PM PDT
Venue : Doubletree Hotel San Diego Downtown
Price: $1,295.
Register now and save $200. (Early Bird)
Until July 31, Early Bird Price: $1,295.00
from August 01 to September 17, Regular Price: $1,495.00

Contact Information:

Event Coordinator
Toll free: 1800 447 9407
Fax: 302 288 6884
Email: support@globalcompliancepanel.com
Website: https://www.globalcompliancepanel.com
LIVE CHAT SUPPORT ALSO - http://www.globalcompliancepanel.com/chat/client.php

EVENT Link - http://bit.ly/15QcPyJ

GlobalCompliancePanel
NetZealous LLC
43337 Livermore Common, Fremont CA 94539, USA

Overview: At the end of this webinar, participants will understand some of the issues that create the high turnover in clinical research staff and will get some solutions.

Most of the companies in the clinical research field have a high turnover rate of the clinical research professionals. This results in almost higher HR and training costs and lower performance.

Why should you attend: Do you have a high turnover rate in clinical research professionals in your company? Are you looking for solutions??
If your answer is "yes" to one of these questions attending this one-hour webinar will help you. This session will briefly review the some of the issues that create this turnover from the clinical research professional’s part

Areas Covered in the Session:
Clinical Trials Resourcing

Who Will Benefit:
CRO staff involved in the design of clinical trials
Industry Sponsors involved in development of drugs and biologics
HR professionals

Calin Enea Popa, MD, CCRA is the Founder and President of Advanced Clinical Research Service Inc. a Canadian full-service CRO that provides CRO services and training to FDA and Health Canada regulated industries. He provides ICH-GCP training and training for FDA and Health Canada regulations.

USA
GlobalCompliancePanel,
Livermore Common, Fremont, CA, 94539

USA Phone:800-447-9407
Fax: 302-288-6884
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

http://bit.ly/Xue5pr

Overview: Water system microbial excursions are the bane of laboratories, utility operations, and production, often causing huge expenditures of labor for system sanitization and additional testing and quarantines of whole systems or specific outlets while fruitless investigations are mounted, not to mention the potential cost of product rejections when root causes are not definitive.

Though some excursions are real and a sign of system control problems, most are probably self-inflicted, being caused by poorly designated "trigger values", poorly designed use points, or poorly executed sampling or testing. This presentation will explore these possible causes, including the symptoms of real (as well as false) water system problems, and provide effective alternatives to avoiding most of your current superfluous excursions, as well as how to build supporting data useful in pinpointing causes when investigations are indeed necessary.

Why Should You Attend: When was the last time you performed a water system excursion investigation and could not definitively conclude the root cause? If you are like most firms, this scenario was probably your most recent experience, happens quite often, and frankly, is probably completely unnecessary. Most excursions are usually caused by self-inflicted phenomena. This presentation will discuss the most common causes of microbial excursions in water systems and how they can easily be avoided with minimal effort. Just think of the resources, production downtime, product losses, and cost you could save by making a few rational changes to your action "trigger values", sampling and testing, while still being able to (more clearly now) see real system problems when they do occur. You simply cannot afford to not tune in to this valuable webinar!

Areas Covered in the Session:
What are excursions?
Water system dilemma: process control or quality control (utility or raw material), or both
Intended functions of Alert/Action Levels and Specifications
Investigation, necessary and often fruitless
Excursion responses and impact
Criticality of valves, hoses, & outlet flushing
Diagnosing the source of the problem
Minimizing unnecessary excursion responses through best practices

Who Will Benefit: This webinar will be valuable for all companies that operate WFI or Purified Water systems, particularly for those in FDA and EMEA regulated industries, including Medical Devices, Diagnostics, Pharmaceuticals, and Biologics fields, as well as consumer products and cosmetics companies. The employees who will benefit include:
QA managers and personnel involved in investigations of excursions and preparing CAPAs
QC managers and personnel involved in sampling, testing, and trending chem and micro data from water systems
Utility operators and their managers involved in maintaining and sanitizing water systems
Validation managers and personnel
QA managers and other personnel involved in Change Control programs
QA managers and Regulatory Affairs personnel involved in defending water system operations and quality data to FDA and EMEA inspectors and outside auditors
Consultants and Troubleshooters

T.C. Soli, is a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc. (www.solipharmasol.com), and since becoming a full time consultant, has served consumer products and FDA-regulated industries with training and troubleshooting expertise covering water systems, sterilization, aseptic processing, microbiological.

USA
GlobalCompliancePanel,
Livermore Common, Fremont, CA, 94539

USA Phone:800-447-9407
Fax: 302-288-6884
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

http://bit.ly/Yyk5Nw

Overview: Per the CDRH, 20% of product recalls in the medical device industry are due to faulty software!!! Yet, these human, financial and reputation capital expensive issues, can be averted with computerized systems validation and 21 CFR 11 compliance. The Project Manager for a Validated Computerized System, has to deliver on time and on budget, but with the added risk of having to meet regulatory compliance, often causing project overruns, regulatory findings and missed times to market.

This class, will explain the basic tenets of project management, the basic tenets of 21 CFR 11 compliance for Computer Systems Validation and will show how to marry the two, to deliver on time and on budget while meeting regulatory compliance requirements.

Areas Covered in the Session:
FDA Inspections - background
Causes of Form 483 / Warning Letter
Some recent results of companies failing to respond appropriately
Best Practices for Responding to 483
Best Practices for Responding to Warning Letter
What to do if the responses fail

Who Will Benefit:
Project Managers
IT Management
Business Process Owners
Quality Managers
Quality Engineers
GxP
Consultants

Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. "Your Passport to Compliance". She has 30 years of experience in the Lifesciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance.

USA
GlobalCompliancePanel,
Livermore Common, Fremont, CA, 94539

USA Phone:800-447-9407
Fax: 302-288-6884
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

http://bit.ly/ZpaZRu

Overview: Building on the introductory concepts of the One-level, One-factor design used for the ANOVA, this webinar will introduce the worker to DOE at the level of the Two-level Factorial Design.

The webinar will be based on a single two-level, three-factor experiment whose design will be explained, and its results analyzed using several methods to test the validity of our conclusions. The linking of Critical Process Parameters (CPP) to Critical Quality Attributes (CQA) will be described.

Areas Covered in the Session:
The simplest designed experiment and its superiority over an OFAT study.
Description of a 3-factor, 2-level design.
Use of coding and the standard order.
Calculating effects (contrasts)
Looking for interactions
Testing the effects with a half-normal plot.
Relating CPP to CQA

Who Will Benefit: By raising the level of complexity to a two-level, three-factor study, the QC and manufacturing worker will now be introduced to designed experiments. A single processing study will be used to provide examples for the design and analysis of an experiment.
Regulatory Affairs personnel who prepare the CMC sections of submissions.
Development personnel who will set the early specifications.
R & D personnel who will contribute data for use in development.
Project managers for product development studies.
Quality systems auditors
Consultants.

Steven S. Kuwahara, Ph.D. is the founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals.

USA
GlobalCompliancePanel,
Livermore Common, Fremont, CA, 94539

USA Phone:800-447-9407
Fax: 302-288-6884
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
http://bit.ly/14nhhTh

Overview: This webinar will serve as an introduction to the Design of Experiments (DOE) by expanding upon the concept of the Analysis of Variance (ANOVA) that was presented in an earlier webinar.

The webinar will describe the concepts of blocking and randomization to remove sources of variability, and present an analysis of a design containing a single block with multiple subjects. The webinar will contain a brief review of the earlier presentation on ANOVA. Studies will be based data generated in a pharmaceutical company.

Areas Covered in the Session:
A review of the basic ANOVA method and the equations used for generating F-values and the corresponding p values.
The concept of blocking.
Analysis of an unblocked experiment
Analysis of the same experiment after blocking

Who Will Benefit: This webinar is designed to introduce the QC and manufacturing worker to the basic concepts of the analysis of variance. The application of ANOVA to analyzing one level, one way data will be covered using a case study.
Regulatory Affairs personnel who prepare the CMC sections of submissions.
Development personnel who will set the early specifications.
R & D personnel who will contribute data for use in development.
Project managers for product development studies.
Quality systems auditors
Consultants.

Steven S. Kuwahara, Ph.D. is the founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals.

USA
GlobalCompliancePanel,
Livermore Common, Fremont, CA, 94539

USA Phone:800-447-9407
Fax: 302-288-6884
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

http://bit.ly/Ws0iAW

Overview: Process validation is an important element in medical device manufacturing. This webinar looks at the underlying statistical concepts to perform an effective process validation. The webinar examine elements of the FDA regulations for process validation (21 CFR §820.75) as well as the corresponding requirements in ISO 13485.

When you cannot (or do not) fully verified process results by subsequent inspection and test this leads to sampling plans. We discuss the use of attribute sampling plans in this context.

When you validate the process with a high degree of assurance, this means your process achieves a certain process capability. We discuss the concepts of process capability, especially the use of Cp and Cpk.

Operational Qualification (OQ) explores the parameter space that defines the process and selects challenge points as part of the qualification protocol. This naturally leads to Designed Experiments as the exploratory tool.

Lastly, Risk Management (ISO 14971) includes production information. This leads directly to validated processes since these are often the production processes that carry the greatest risk.

Why should you attend : If you conduct process validation, you need to ensure that your results are valid. Beyond the regulatory requirements, statistical approaches will help you achieve the desired result – processes that produce only conforming material. This is the essence of the statistical approach.

This webinar presents the statistical approach that will help you validate your processes. Your team should attend this webinar if you cannot easily answer these questions.
Can you give the statistical rational for you verification sampling plans?
Can you state the desired and actual process capability you need to achieve?
Can you list the worst-case input parameter combination for your process?
Do you know how to determine challenge points for your process?
Have you set action limits for your process inputs?
Areas Covered in the Session
QMS Requirements for Process Validation
FDA’s QSR (21 CFR §820.75)
ISO 13485:2003
The Statistical Process Model
Relating input to output
The Process Output
Sampling Inspection
Process Capability
The Process Input Parameters
Design of Experiments
The Challenge Points
Risk Management
Production Information
Validated Processes as High Risk
Learning objectives:
Understand the QSR requirements for process validation
Explain the FDA’s approach as documented in Warning Letters
Understand the ISO 13485 requirements for process validation
State the statistical model that links process input and process output
Link sampling verification to the process model
Understand the role of process capability and describe the desired values of the indices
Understand the role of designed experiments in determining the input parameter space
Describe the role of challenge points in Operational Qualification
Recognize the role of process validation in Risk Management
Who Will Benefit:
This seminar is for people involved in the validation of production processes. Validation requirements start in the design output (setting the requirements), continues to design transfer (where the requirements are set as process parameters), and finally to process validation to ensure the resulting output achieves the requirements.

Attendees should understand design, development, and manufacturing processes.

People in the following roles can especially benefit from the knowledge in this webinar:
Quality Managers
Quality Engineers
Production Managers
Production Supervisors
Manufacturing Engineers
Production Engineers
Design Engineers
Process Owners

Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management.

USA
GlobalCompliancePanel,
Livermore Common, Fremont, CA, 94539

USA Phone:800-447-9407
Fax: 302-288-6884
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

http://bit.ly/XIwE7N

Overview: Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s.

This session will include the requirements for defining, documenting, and implementing a complaint-handling system, including the requirements for complaint review, investigation, and corrective action, as well as the ISO-specific implications. This session will discuss the best way to document customer feedback, what constitutes a complaint, and what do with "non-complaint" feedback. Also contained will be a suggested method on including complaint trending into your firm's CAPA program. Additionally, the application of risk management to a complaint handling system will be reviewed, and a specific risk management system explained.

Areas Covered In the Session:
FDA and ISO requirements for complaint handling
Establishment of complaint handling program
What constitutes a complaint
ISO-specific implications of complaint handling
The roles of investigation and corrective action in complaint handling
Complaint trending and reporting
Application of risk management to complaint handling program

Who will benefit:
Regulatory Management
Quality Management
Customer Service Personnel
Sales Personnel
Quality System Auditors
Consultants

Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy and colonoscopy devices, where he oversees the operation of the quality system. In this position, Jeff is responsible for oversight of the document control system, including maintenance of regulatory documentation.

USA
GlobalCompliancePanel,
Livermore Common, Fremont, CA, 94539

USA Phone:800-447-9407
Fax: 302-288-6884
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

http://bit.ly/13hbeTR

Overview: Medical Device Reporting (MDR) is the mechanism for the Food and Drug Administration to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. If you are a consumer or health professional you should use the MEDWATCH program for reporting significant adverse events or product problems with medical products.

Although manufacturers and importers of medical devices have been required since 1984 to report to FDA all device-related deaths, serious injuries, and certain malfunctions, numerous reports have shown there is widespread underreporting. On July 31, 1996, the new Medical Device Reporting (MDR) regulation became effective for user facilities and device manufacturers. The statutory authority for the MDR regulation is section 519(a) of the FFD&C Act as amended by the Safe Medical Devices Act (SMDA) of 1990.

Areas Covered in the Session:
What form should I use to submit reports of individual adverse events and where do I obtain these forms?
How will I know if I require more information about my medical device report?
Reporting device-related deaths and serious injuries and when these are not treated as a product complaint
Understand the manufacturer's reporting requirements and expectations
Are there exemptions, variances, or alternative forms of adverse event reporting requirements?
Learn what constitutes a MDR and how to facilitate this for compliance success
Develop, maintain, and implement written MDR procedures and achieve compliance
Learn why FDA is amending its MDR regulations to remove a requirement for baseline reports that the agency deems no longer necessary

Who Will Benefit: This webinar will provide valuable assistance and guidance to all medical device companies and user facilities that are required to manage or comply with the provisions of the 21 CFR 803 MDR program. The employees who will benefit include:
All levels of Management for all departments and those who desire a better understanding or a "refresh" overview
QA/QC
Regulatory Affairs and Compliance
Engineering/Technical Services/Operations
Consultants

David R. Dills, an independent Regulatory & Compliance Consultant with more than 22 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices and managing and handling activities within the global regulatory and compliance landscape.

USA
GlobalCompliancePanel,
Livermore Common, Fremont, CA, 94539

USA Phone:800-447-9407
Fax: 302-288-6884
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
http://bit.ly/ZFGjzS