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: 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: 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 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: Learn computer system validation essentials and eight fundamental steps of implementation for cost saving. Get complementary SOPs and checklists for easy implementation. Understand the structure of validation plan, documentation of ongoing performance, structure of validation report.

Why Should You Attend: The validation of computer system has been an FDA requirement since more than 20 years. Nevertheless companies have problems with implementation. This is proven through many FDA warning letters related to software and computer system validation, especially in the last three years. Validation professionals know the principles but have problems with implementation, especially with the development of protocols. This seminar will give a good understanding of FDA requirements for computer system validation and provide steps for cost-effective implementation.

Areas Covered In the Session:

• US FDA and EU requirements and enforcement practices
  
• Learning from recent FDA 483's and warning letters
  
• Selecting the right validation model: qualification vs. verification
  
• Eight fundamental steps for computer system validation
  
• Structure and example of a validation plan
  
• Justification and documentation of risk levels
  
• Example qualification document for suppliers of commercial systems
  
• Examples for requirement and functional specifications?
  
• Example for IQ protocols
  
• OQ test protocols: development, execution, approval - examples
  
• Documentation of ongoing performance
  
• Validation of existing systems
  
• Structure and example of a validation report
  
• Step-by-step case studies from laboratories and manufacturing for easy implementation

For easy implementation, attendees will receive:

• SOPs: Validation of Commercial Off-the-Shelf Computer Systems
  
• Checklist: Using computers in FDA regulated environments
  
• Validation templates and examples

Who will benefit:

• IT managers and system administrators
  
• QA managers and personnel
  
• QC and Lab managers
  
• Validation specialists
  
• Regulatory affairs
  
• Training departments
  
• Documentation department
  
• Consultants