• How to use the sampling tables to determine the sampling plan
• Ways to avoid common errors and misunderstandings with the sampling tables
• The difference between single, double, and multiple sampling plans
• Why double sampling plans are the most economical choice
• The reasons for the switching rules between normal, reduced, and tightened
• The use of the switching rules to help improve your supplier management program
• How the switching rules can help you reduce inspection cost

• How to use the c=0 plans instead of Z1.4 plans
• The basis for the plans using the RQL point
• The differences in the OC curves and why they can cause problems
• How a change from Z1.4 to c=0 can impact your inventory and disrupt your suppliers

• How do you know how much your inspection system costs?
• Are you inspecting too much, and wasting money?
• Are you inspecting too little and incurring risk?
• Do your current managers and supervisors understand how the system works?
• Will your ISO 9001 registrar ask for justification of these statistical methods?
• Should you start to use these c=0 plans you have heard about?
• Can you improve the process?

• 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?

• 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

• Quality Managers
• Quality Engineers
• Production Managers
• Production Supervisors
• Manufacturing Engineers
• Production Engineers
• Design Engineers
• Process Owners

• Discover what the regulations say about documentation practices
  
• Learn what your signature and/or initials mean on a document
  
• See how to correct errors and omissions in data entry
  
• Learn "Do's" and "Don'ts" of documentation practices
  
• Learn how to attach raw data to records
  
• Review rounding and limit expression determinations

• 21CFR Part 211 and Eudralex references to documentation
  
• Correcting errors and omissions
  
• Dates and formats
  
• Meanings of initials and signatures
  
• Use of "NA"
  
• Comments and explanations
  
• Handling raw data (charts, strips, printouts)
  
• Blanks
  
• Entering numerical data

• Production personnel (operators, supervisors)
  
• Laboratory personnel (chemists, technicians, supervisors)
  
• Batch record reviewers
  
• QA Auditors of Production and Laboratory Documents
  
• Validation, Engineering
  
• Maintenance personnel (mechanics, supervisors)
  
• Warehousing personnel

The seminar begins with Excel methods to help ensure the spreadsheet produces the results you want. We explain the built in Validation tools and how to use them to prevent the user from entering incorrect data. We explain the use of Formula Auditing to help ensure the calculations are performed correctly. Lastly, we explain the use of Protection to prevent inadvertent and unauthorized changes. To satisfy the broadest interest, we use Excel 2003 to illustrate the tools.

The seminar shifts to the regulations for automated processes, found in 21 CFR §820.70(i), and explains the requirements for a validation plan. The FDA Guidance document, General Principles of Software Validation, has a section devoted to this kind of software application. The seminar explains FDA’s thinking and shows how to follow the guidance document.

Lastly, we look at the electronic record aspects of the spreadsheet. 21 CFR §820.180 provides General Requirements for records. Part 11 has additional requirements when these are electronic records. We look at the requirements for electronic records and some of the issues these requirements raise. We also examine the current guidance document on electronic records and explain where FDA will exercise "regulatory discretion" and what that means.

We discuss the following issues:

• The pitfalls of using Excel without a good regulatory plan
  
• How to recognize when you are using software in production or the quality system
  
• The use of Excel tools to help ensure spreadsheets are built correctly
  
• The FDA’s requirements and expectation for production and quality system software
  
• The reason for Part 11 and some of the implications
  
• The requirements of Part 11 for electronic records and the current guidance document

Why should you attend: FDA Inspections are based on ensuring compliance with the regulations. Failure to comply can result in the FDA citing the company for a violation, i.e., listing it on an FDA Form 483 Inspectional Observations. The FDA may even escalate these observations to a Warning Letter.

Unfortunately, many well meaning intentions may fail to satisfy the regulations. For example, a manufacturing engineer may recognize that an Excel spreadsheet could reduce the possibility of error in a manual calculation. On its own, the spreadsheet would be a valuable Preventive Action. However if the spreadsheet is not validated, approved, and documented properly it may create a problem during an FDA inspection. An unvalidated spreadsheet violates the QSR requirements for automated processes.

The next easy step is to eliminate the form used in the manual calculation. It would straightforward, as the next step, to reduce the paperwork and just keep the calculations in the spreadsheet. This is potentially an "electronic record", and may violate 21 CFR Part 11.

If manufacturers don't understand the regulations, they could create regulatory problems that are will be hard to fix.

• 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.
  
• Design Inputs - User Requirements Specification; Technical Design Requirements
  
• Design Outputs - Specifications, Drawings, Documents
  
• Traceability Matrix
  
• Applying lean document and lean configuration principles to the above
  
• Bringing it all together

• Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
  
• R&D
  
• Manufacturing Engineering
  
• Quality Assurance
  
• Operations
  
• Document Control