Overview: This webinar covers the statistical methods used to calculate sample sizes for both attribute and variables data.

Methods for collecting the sample will be covered.  Every sampling plan has risks. This webinar covers how to calculate Type I and Type II errors. A discussion of how the FDA views sampling plans, especially for validation and acceptance activities.  Sample size to ensure a certain level of process capability will be covered.

Areas Covered in the Session:

• How to collect a sample
  
• What are the two types of error (Type I and Type II)
  
• How to calculate sample sizes for variables data
  
• How to calculate sample sizes for attribute data
  
• Using confidence intervals on Cpk to calculate a sample size
  
• Using binomial confidence intervals

Who Will Benefit:

• Management
  
• Research and Development
  
• Regulatory Affairs personnel
  
• Quality assurance/quality control personnel
  
• Auditors and inspectors

Overview: The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical File (TF).

Are you maintaining adequate DHF, DMR, DHR, and TF records? Do you know what data and information need to reside and where does it reside? Are your records easily accessible? Are you confused by these terms? Attend this Webinar to have these questions answered. Many citations by FDA and notified bodies include findings with respect to insufficient information in the Design History File, notfollowing the procedures to make the device as established in the DMR, and incomplete or inaccurate production data of incoming,in-process and finished products. Is your company able to access all relevant documents detailing the design of your device? Is your DMR accurate and is it being followed? Can the operators access your DMR? Are you recording and documenting all your production and testing data and maintaining them in the DHR? Do you know what information should reside in a DHF, a DMR and a DHR? This Webinar will define, explain and clarify the different records.

Areas Covered in the Session:

• FDA Quality Systems Regulation Requirements/Definitions
  
• MDD Requirements/Definitions
  
• Design History File (DHF)
• Definition
• Typical contents
• DHF and outsourced design/production
• DHF and OEM relationships
• Device Master Record (DMR)
• Definition
• Typical contents
• DMR and outsourced design/production
• DMR and OEM relationships
• Controlling and maintaining DMR
• Device History Record (DHR)
• Definition
• Contents
• Using DHR data for tracking and trending
• DHR and outsourced design/production
• DHR and OEM relationships
• Technical File (TF)
• Definition
• Contents
• TF and outsourced design/production
• TF and OEM relationship
• Design/process changes and DHF, DMR, DHR, and TF

Who Will Benefit: This Webinar is designed for people involved in document preparation and maintenance, and those who have involvement with documentation. This typically includes:

• Quality Managers/Engineers
  
• Production/Process Managers/Engineers
  
• Manufacturing Managers/Engineers
  
• QA and QC managers, inspectors, supervisors and personnel
  
• Documentation Specialists
  
• Supplier Quality Managers/Engineers
  
• Regulatory Managers/Engineers

Overview: This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.

What makes this session unique is the combination of step-by-step instructions and the hands on workings of each participant. Bring your laptop and use Excel for your own needs. This session will make you a better Excel user, saving you time and costs.

Overview: This webinar details the regulation and how it applies to computerized systems.

Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach. This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to greatly increase productivity.

Overview: This webinar will provide an overview of the FDA guidance document "Deciding When to Submit a 510(k) for a Change to an Existing Device".

All of us in the medical device industry who are marketing devices under the 510(k) substantial equivalence regulations occasionally make changes or improvements to our devices. The question arises whenever a change is made as to whether or not the change being made is "Significant" enough to warrant the submission of a new 510(k). This decision is not always easy and the FDA provides many guidance documents to aid in determining the requirement.
An interpretation of the guidance and real life examples of when a new 510(k) is required will be discussed for each category of change. How does software play in this arena? Also, the path through the various flowcharts contained within the guidance documents lead into one of two directions: a New 510(k) or Documentation. This webinar will also review what is meant by "Documentation" or a "Letter to File" as it is also referred to and what the content of that documentation should be.

Overview: This webinar will examine the broad range of issues to be considered by a company when reviewing 1) a series of minor changes or 2) one major change to an existing product having an existing 510(k), for the need for a new 510(k).

Such a review takes on added urgency as a result of the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what it (the FDA and industry) need to do to "toughen" the 510(k) process. A review of recent information from the Agency, including last summer's Working Group findings on the 510(k), Vol. I, as well as other goals of the Agency that have already been translated into action in the past year will provide direction in areas of concern and what to expect in the future. This will be performed by a review of FDA-stated areas of required review and a suggested matrix format. Anticipation and addressing such on-going product modifications / changes proactively will further prove a company is "in control", and assist documenting the 510(k) submission (or 'not') rationale.

Why should you attend: The FDA expects companies to perform meaningful, results driven 510(k) / change analysis activities. The company is held fully responsible for deciding when a new 510(k) filing is warranted. Growing high-profile field problems indicate that change control and it’s effect on regulatory review activities are not yet fully utilizing the power of current risk management tools, which must be a part of such an analysis. A growing push by the Agency to strengthen the 510(k) process in the U.S. and take a renewed look at "grandfathered" product by the Agency is one result. Current methods are claimed to not be providing the product safety or efficacy seemingly promised. For most companies, the fixes are not rocket-science, but require the implementation of formal methods with documented and defensible rationale.

Areas Covered in the Session:

• FDA Device Clearance / Changes in Direction
  
• Product Changes and Filing a New 510(k) Responsibilities
  
• Tracking / Evaluating Changes and the "Tipping Point"
  
• "Risk-Based"
  
• FDA's K97-1 and "Decision Tree" Model / Matrix
  
• Resolving a "Wrong" Decision
  

Who Will Benefit:

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

Overview: Excel Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.

Regulations such as HIPAA, Sarbanes Oxley Act and FDA's GxP and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality. Out-of-the box Excel has not been designed for regulated environments. However, with a good knowledge of Excel capabilities combined with good procedures and practices on how to validate and use Excel requirements can be met. For example, the FDA is widely using Excel and complies with its own regulations.

Areas Covered in the Session:

• Regulatory requirements for spreadsheets; FDA Part 11, GxP, HIPAA, Sarbanes-Oxley.
  
• Recommendations from the new GAMP®5 and EU Annex 11
  
• How to design spreadsheets for compliance.
  
• How to ensure and validate spreadsheet integrity.
  
• When, what and how much to test?
  
• Validation of standard/native Excel functions?
  
• How to apply risk based validation to spreadsheet applications
  
• Validation of 'ad hoc' spreadsheet applications.
  
• How to document planning, specifications, installation, testing and changes
  
• Examples from manufacturing, laboratories and offices

Who Will Benefit:

• Everybody developing Excel Worksheets for regulated environments
  
• QA Managers and personnel
  
• QC Managers and personnel
  
• Analysts and Lab Managers
  
• Validation Groups
  
• Validation Professionals
  
• Training Departments
  
• Documentation Department
  
• Consultants

Overview: The FDA QSR requires device manufacturers to validate processes when the manufacturer cannot "fully verify the output".

The manufacturer must validate these processes with a "high degree of assurance". The presentation explores the statistical underpinnings of these two phrases. To "fully verify the output" relates to the use of statistical sampling plans, while "high degree of precision" relates to process capability. The presentation illustrates the statistical concepts.

The Global Harmonization Guidance document on process validation shows the application of statistical techniques. In particular, the guidance explains the use of design experiments (DOE) to establish process parameters and develop challenge points for the Operational Qualification (OQ) phase. The guidance explains the concepts of process capability showing the relationship between the process statistical characterization and the engineering specification transferred from design. Statistical Process Control (SPC) is an important technique in the Performance Qualification (PQ) phase of validation.

The presentation concludes by showing the strong relationship between validated processes and Risk Management. ISO 14971:2007 requires that production (and post-production) information go back to Risk Assessment to help complete the life cycle. Validated processes, where the manufacturer cannot fully verify the output, present a risk of product “escape”. Statistical information of each lot from a validated process should be part of the Risk Management File.

Why you should 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 Seminar:

• 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

Who will benefit: 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

Overview: This webinar will teach how Design Verification and Validation, Process Validation, Risk Management and Purchasing Controls work together to produce safe medical devices.

Why should you attend: FDA continues to issue Warning Letters to companies that fail to properly complete Design Verification, Design Validation, Process Validation and recently has issues Warning Letters including failures of manufacturers in Risk Management.

This webinar will show how Design Verification, Design Validation, Process Validation, Risk Management and Purchasing Controls work together to produce safe medical devices.

Also discussed are risk management documentation tools used to meet the requirements of the ISO 14971 standard during these final phases of product development. Not only will meet regulatory requirements be a subject of the presentation, but also doing so efficiently.

Overview: This webinar will discuss the new draft guidance document from the FDA: "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", dated July 27, 2011. It will examine the broad range of issues to be considered by a company when reviewing 1) A series of minor changes or 2) one major change to an existing product having an existing 510(k), for the need for a new 510(k).

Such a review takes on added urgency as a result of the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what it (the FDA and industry) need to do to "toughen" the 510(k) process. A review of recent information from the Agency, including last summer's Working Group findings on the 510(k), Vol. I, as well as other goals of the Agency that have already been translated into action in the past year will provide direction in areas of concern and what to expect in the future. This will be performed by a review of FDA-stated areas of required review and a suggested matrix format. Anticipation and addressing such on-going product modifications / changes proactively will further prove a company is "in control", and assist documenting the 510(k) submission (or 'not') rationale.

Why should you attend: The FDA expects companies to perform meaningful, results driven 510(k) / change analysis activities. The company is held fully responsible for deciding when a new 510(k) filing is warranted. Now a new draft guidance document from the FDA is designed to add more consistency to this process: "510(k) Device Modifications:  Deciding When to Submit a 510(k) for a Change to an Existing Device", dated July 27, 2011. In addition, growing high-profile field problems indicate that change control and it's effect on regulatory review activities are not yet fully utilizing the power of current risk management tools, which must be a part of such an analysis. A growing push by the Agency to strengthen the 510(k) process in the U.S. and take a renewed look at "grandfathered" product by the Agency is another result. Current methods are claimed to not be providing the product safety or efficacy seemingly promised. For most companies, the recommended fixes are not rocket-science, but require the implementation of formal methods with documented and defensible rationale.

Areas Covered in the Session:

• FDA Device Clearance / Changes in Direction
  
• The New Draft Guidance on Product Changes and Filing a New 510(k)
  
• The New Guidance on Manufacturing, Labeling, Tech/Performance and/or+B41 Materials Changes
  
• Tracking / Evaluating Changes and the "Tipping Point"
  
• FDA's K97-1 and "Decision Tree" Model / Matrix
  
• Resolving a "Wrong" Decision

Who Will Benefit:

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