mariahuber.de
Validation of Computer Systems - Training and Tools for Implementation
http://mariahuber.de/books/computers/default.aspx
All documents as shown here are included in the package, and many more! A total of 22 SOPs are included in the package. 15 of them are shown here. 9 Forms are included in the package. They help to make computer system validation consistent and effective. Cost Effective Validation of Computer Systems. Computer System Validation Package. Do it right the first time. Two audio seminars and free on-line updates. Now with two Options for Ordering. This package helps you to. Develop a strategy and master plans.
labcompliance.com
Managing Electronic Raw Data in Regulated Environments
http://www.labcompliance.com/seminars/audio/360/default.aspx
All documents shown here are included in the seminar for instant download. Data Integrity and Fraud - An Other looming Crisis. Warning letters and Inspectional observations related to raw data and other electronic records. Labcompliance On-line Audio Seminar. To share this seminar info with your colleagues, click here. On-line Audio Seminar 360. Managing Electronic Raw Data in Regulated Environments. Definition, generation, evaluation and archiving for FDA, PIC/S and EU compliance. We move to a new compu...
labcompliance.com
Validation of Analytical Methods according to the New FDA Guidance
http://www.labcompliance.com/seminars/audio/336/default.aspx
All documents shown here are included in the seminar for instant download. Analytical method validation - A Regulatory Perspective. Learn from FDA Warning Letters what inspectors look for and what mistakes other companies make so you can avoid them. Labcompliance On-line Audio Seminar. To share this seminar info with your colleagues, click here. Validation of Analytical Methods according to the New FDA Guidance. Understanding FDAs New Lifecycle Approach for Method Validation. Recently the FDA has release...
labcompliance.com
Security and Integrity of Electroinc Records for FDA
http://www.labcompliance.com/seminars/audio/353/default.aspx
All documents shown here are included in the seminar for instant download. Data Integrity and Fraud - An Other looming Crisis. FDA Regulatory Perspective on Data integrity. Warning letters and Inspectional observations related to raw data and other electronic records. Labcompliance On-line Audio Seminar. To share this seminar info with your colleagues, click here. So far we have received very positive feedback from. Attendees of Ludwig Hubers seminars on FDA Part 11 inspections ,. How to define raw data?
labcompliance.com
Quality by Design (QbD) for Development and Validation of Analytical Methods
http://www.labcompliance.com/seminars/audio/354/default.aspx
All documents shown here are included in the seminar for instant download. The seminar material includes three forms related to Method Validation through QbDr. The seminar material also includes a Presentation with an update on the status the FDAs QbD initiative. QbD for Better Method Validation and Transfer. Quality by Design Systematic Chromatographic Method Development. Attendees get access to FDA warning letters related related to inadequate method validation. Labcompliance On-line Audio Seminar.
labcompliance.com
Labcompliance
http://www.labcompliance.com/newsletter/ordering/default.aspx
Now you can get free update information on validation and compliance through an e-newsletter. News from FDA and other agencies: regulations, guidance documents, inspection and enforcement practices. News from industry task forces and other organizations, like ICH, ISPE, PDA, task forces etc. Information and links to new literature for free downloads from the Internet. New FDA warning letters, 483 inspectional observations and inspection reports. Information on new conferences and seminars. Dr Ludwig Hube...
labcompliance.com
Ensuring Integrity of Laboratory Data
http://www.labcompliance.com/books/labdataintegrity/default.aspx
All documents as shown here are included in the package. A total of 25 SOPs are included in the package. Ensuring Integrity and Security of Electronic Records for FDA Compliance. Is included in the package. Laboratory Data Integrity Package. With controls and examples for FDA and EU compliance. So far we have received very positive feedback from. Customers of Ludwig Hubers documents and seminars on data integrity and FDA Part 11 inspections ,. To see the feedback click here. W ith two Options for Ordering.
labcompliance.com
Managing Out of Trend Results in Pharmaceutical Manufacturing and Quality Control
http://www.labcompliance.com/seminars/audio/355/default.aspx
All documents shown here are included in the seminar for instant download. Labcompliance On-line Audio Seminar. To share this seminar info with your colleagues, click here. On-line Audio Seminar 355. FDA/EU Compliant Handling of OOX Test Results. Learn how to investigate out-of-trend (OOT) and out-of-expectation (OOE) vs. OOS results. Recorded, available with all reference material at any time. Key Questions related to OOT and related failure investigations are:. How to define OOT and OOE limits? How doe...
labcompliance.com
Managing Electronic Raw Data in Regulated Environments
http://www.labcompliance.com/seminars/audio/328/default.aspx
All documents shown here are included in the seminar for instant download. Data Integrity and Fraud - An Other looming Crisis. Warning letters and Inspectional observations related to raw data and other electronic records. Labcompliance On-line Audio Seminar. To share this seminar info with your colleagues, click here. On-line Audio Seminar 328. Understanding FDAs New Guidance on Electronic Source Data in Clinical Investigations. With tool kit for cost effective implementation. For how long should source...
labcompliance.com
Qualification of Virtual Networks and Cloud Computing
http://www.labcompliance.com/seminars/audio/362/default.aspx
All documents shown here are included in the seminar for instant download. Labcompliance On-line Audio Seminar. To share this seminar info with your colleagues, click here. So far we have received very positive feedback from. Attendees of Ludwig Hubers seminars on Network and Infrastructure qualification. To learn how. Seminars and the Labcompliance Network Quality Package helped to. Networks and Infrastructure click here. Qualification of Virtual Networks and Cloud Computing. Key Questions related to.