All Events in Canada (25)

Webinar On 21 CFR 11 Compliance for Excel Spreadsheets

May 5, 2015 from 1pm to 2pm – Canada Description : In Dec. 2010, the FDA has stepped up enforcement for 21 CFR 11 compliance with spreadsheets being considered as low hanging fruit for FDA inspectional findings. Spreadsheet Applications… Organized by Compliance Trainings | Type: webinar

Webinar On Verification vs Validation

May 6, 2015 from 1pm to 2pm – Canada Description : This webinar will focus on the difference between Verification vs Validation and how can we use them to improve the bottom line. If Verification &Validation are done right, the proc… Organized by Compliance Trainings | Type: webinar

Webinar On Learning from Recent FDA Warning Letters related to Part 11 and Computer Validation

May 7, 2015 from 1pm to 2:15pm – Canada Description : Some time ago FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, now it looks more like an ongoing program with Part 11 rela… Organized by Compliance Trainings | Type: webinar

Webinar On Managing the FDA form "483": Inspection Observations

May 12, 2015 from 1pm to 2pm – Canada Description : This webinar is a complete guide on how to manage the FDA's 483 observations during and after an inspection. How you respond can make or break you. Form FDA 483 is a list of observation… Organized by Compliance Trainings | Type: webinar
Webinar On Sampling: How Large a Sample Do I Need? Determining the Right Size for Accurate, Cost Effective Results

May 12, 2015 from 1pm to 2pm – Canada Description : This webinar provides some practical and useful answers to this question. Methods for determining appropriate sample sizes in raw materials acceptance, finished product release, proces… Organized by Compliance Trainings | Type: webinar

Webinar on Extending Your Quality System from Medical Devices to Manufacturing of Combination Products, Your Unique Challenges and How to Overcome them

May 15, 2015 from 2pm to 2pm – Canada Description : This webinar presents important facts to simplify the planning and execution phase in your journey towards becoming a combination device manufacturer by incorporating the essential qua… Organized by Compliance Trainings | Type: webinar

Webinar Ensuring Data Integrity for FDA/EU Compliance

May 20, 2015 from 1pm to 2:15pm – Canada Description : FDA has found and reported about multiple cases where companies manipulated electronic records. Since then FDA inspectors have focused inspections on security, availability, accuracy a… Organized by Compliance Trainings | Type: webinar

Webinar On Normality Tests and Normality Transformations

June 24, 2015 from 1pm to 2pm – Canada Description : The calculations used in many statistical tests and methods require that the inputted data be “normally distributed”. Such calculations include those for t-Tests, ANOVA tables, F-tests,… Organized by Compliance Trainings | Type: webinar

Webinar On Hazard Analysis and Product Risk Management under ISO 14971 and ICH Q9

November 3, 2015 from 1pm to 2:30pm – Canada Description : This webinar will address the procedures, provide and discuss suggested templates, necessary to develop or modify and then use the ISO 14971 and Q9 models to perform and document such a… Organized by Compliance Trainings | Type: webinar

Webinar On HIPAA Requirements for Safeguarding Protected Health Information

May 3, 2016 from 2pm to 2:30pm – Canada Description : Being in compliance with HIPAA involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures of protected health information, but also… Organized by compliancetrainings | Type: webinar