About
Conferences on August 28, 2012
The 510(k) Submission: Requirements, Contents, and Options
Location:
California
/
United States
This 510(k) training will discuss the submission process and the contents required by the FDA for a successful 510(k) submission. It will also provide an understanding of the common pitfalls, delays, and possible preventive measures.
7th Annual Skilling Australia and Workforce Participation Summit
The 7th annual Skilling Australia and Workforce Participation Summit brings together industry, peak bodies, state and federal government representatives, tertiary and training leaders to debate the challenges for skilling, consider current priorities for national skilling and the state strategies for skilling and workforce participation. The two days will feature diverse sector views on supply and market demand, consider the challenges for policy, the key influences on workforce participation and discuss the strategies for future skilling to drive the growth of the Australian economy. The conference is also a great opportunity to discuss skilled migration and investment in training government, tertiary and industry sectors roles.
Validation and Use of Excel® Spreadsheets in Regulated Environments
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.
For easy implementation, attendees will receive:
User Manual with Excel functions that help to comply with FDA requirements
...
Validation and Use of Excel® Spreadsheets in Regulated Environments
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.
For easy implementation, attendees will receive:
User Manual with Excel functions that help to comply with FDA requirements
...
Design Inputs - Design Outputs Traceability Matrix - Principles of Lean Documents and Lean Configuration - Webinar By GlobalCompliancePanel
Overview: Design Inputs, Design Outputs, and Traceability matrices present a challenge to almost all industries that apply design controls. Typically, these cause the creation and maintenance of duplicate information across various documents - a major source of errors. This webinar applies the Theory of Lean Documents and the corresponding Theory of Lean Configuration to avoiding these errors, while presenting a fresh new approach to these key and related documents.
Why you should attend: Do you find yourself constantly struggling to create, manage, and maintain all of the information found in Design Inputs, Design Outputs, and traceability matrices - which is often redundant, repetitive, and chained together in a cumbersome way? Do you find that your design and manufacturing resources ...
Strategies for Preparing and Submitting Successful Citizen Petitions and Suitability Petitions to FDA
Location:
United States
This 90-minute webinar will recommend strategies for filing successful Citizen Petitions and Suitability Petitions with the U.S. Food and Drug Administration. You will learn techniques for drafting and filing successful petitions including the required elements of such petitions and the types of substantiation needed to support them.
Why Should You Attend:
The webinar is intended to provide participants with strategies for drafting targeted and effective Citizen Petitions and Suitability Petitions for submission to FDA. Recommendations for strengthening petitions and increasing the chances of ultimate success will also be provided.
Laboratory Water Quality: More to it than you think!
Location:
United States
This 90-minute course will is designed to help you logically investigate and define the specific quality attributes that your lab water systems need. By attending this training, you will be able to determine the potential deficiencies in your chosen solutions to providing water for your laboratories, rectify them and ensure regulatory compliance.
Why Should You Attend:
Maintaining appropriate quality of lab water systems is perhaps more important than many applications of manufacturing’s water systems. This is because the tests performed on manufacturing’s products can be affected by the lab water quality in insidious, hard to detect ways, which could cause perfectly good products to appear to fail testing or bad product to appear to pass.
Characterization and Comparability Testing of Biosimilars (Biosimilar Analytics)
Location:
United States
This 90-minute webinar will cover the global Biosimilar guidances and provide an overview of analytical studies for a Biosimilar CMC package.
Why Should You Attend:
Analytical characterization and comparability studies will determine the amount of Clinical and non-clinical studies required for registration of a Biosimilar product. Hence, Analytical Strategy is a critical element of Biosimilar product development plan. A comprehensive analytical package can minimize the amount of clinical studies and control costs of a Biosimilar development program.
