April 29, 2009
Check out for medical device trainings/webinars
1. Process Validation for Medical Device Manufacturers
This Process validation training will discuss the CDRH interpretation of the GHTF guidance and how manufacturers should develop Process Validation Plans and conduct production Process Validation.
2. Risk Analysis and Human Factors Engineering
The Risk analysis training will incorporates these techniques into the overall product lifecycle using the principles of ISO 14971 and how to develop an integrated program incorporating risk analysis and human factors engineering.
3. Basic Requirements for Steam Sterilizer Validation per ISO 17665
This Steam Sterilization training will review the general requirements for performing a steam sterilizer validation via the “overkill” half-cycle method as described in ISO 17665 (supersedes ISO 11134).
4. Japan – Regulatory Filing Requirements and Compliance Processes for Life Sciences PART II
This Regulatory compliance training is designed to provide an overview of the regulatory environment in Japan.
5. A Case Study in Equipment / Process Software Verification and Validation
This FDA compliance Training will guide through the models simplifies regulatory requirements for equipment software V&VT, assuring key FDA requirements are not overlooked. QMS and 21 CFR Part 11 require yet another approach.
6. Japanese PAL – JPAL QMS requirements in Ordinance 169 and differences to ISO 13485
This JPAL (Japanese Pharmaceutical Affairs Law) QMS will explore, in detail, the QMS requirements placed on the foreign manufacturer via Ministerial Ordinance 169, Ordinance 2 and Ordinance 179.
April 29, 2009
International Financial Reporting Standards (IFRS) are Standards, Interpretations and the Framework adopted by the International Accounting Standards Board (IASB).
IFRSs are considered “principles based” set of standards in that they establish broad rules as well as dictating specific treatments.
International Financial Reporting Standards comprise:
* International Financial Reporting Standards (IFRS) – standards issued after 2001
* International Accounting Standards (IAS) – standards issued before 2001
* Interpretations originated from the International Financial Reporting Interpretations Committee (IFRIC) – issued after 2001
* Standing Interpretations Committee (SIC) – issued before 2001
Objective of financial statements
A framework is the foundation of accounting standards. The framework states that the objective of financial statements is to provide information about the financial position, performance and changes in the financial position of an entity that is useful to a wide range of users in making economic decisions, and to provide the current financial status of the entity to its shareholders and public in general.