Home » Regulatory Compliance » Article on Statistics for the Non-Statistician

Venue, date and timings: The venue for this seminar is Hilton Zurich Airport Hohenbuehlstrasse 10, 8152 Opfikon Glattbrugg Zurich Switzerland. The seminar shall be on third & 4th March, from 9 A.M to six P.M What the seminar is about: The goal of this seminar is to equip members with a deeper understanding of statistical instruments and methods that may assist enhance the standard of a agency’s course of and product. If statistical evaluation isn’t correctly carried out and/or understood, a agency can run the danger of distributing the form of product to the market that finally fails, leading to misplaced money and time. Statistics after all, requires fixed follow. This seminar shall be extremely interactive and participative. The Knowledgeable will allow members to use their studying of statistics to real-world instance information units. This system begins by offering a fundamental overview of the commonest statistical instruments and phrases. The course covers using statistical software program packages and the position of software program in statistical evaluation and statistical course of management. A few of the broad areas addressed embody: a. the best way to use statistics to correctly pattern information b. help the annual product evaluate c. justify course of adjustments d. set product specs. By the top of day two, course members may have acquired the abilities essential to design a statistically sound sampling plan that helps them adjust to FDA APR necessities. One of many excellent options of this studying session is that all through its period, it is going to enable full interplay of the members with each an skilled teacher and their friends. In regards to the Speaker: Mr. Steven Walfish is the President of Statistical Outsourcing Providers, a consulting firm that gives statistical evaluation and coaching to FDA regulated industries. Previous to beginning Statistical Outsourcing Providers, Mr. Walfish was the Senior Supervisor, Biostatistics (Non-clinical) at Human Genome Sciences in Rockville MD. Previous to becoming a member of HGS, Mr. Walfish was a Senior Affiliate at PricewaterhouseCoopers, specializing within the pharmaceutical business. In different capacities, Mr. Walfish was Supervisor of Non-Medical Statistics at Chiron Diagnostics. Mr. Walfish has over 20 years of business experience within the growth and software of statistical strategies, in the course of the course of which he has solved advanced enterprise points together with information assortment, evaluation and reporting. The agenda:

The seminar shall be utterly pushed by interplay and hands-on engaged on the training areas. It’s going to include the next agenda: Day 1: Agenda Lecture 1: Introduction and Primary Overview of Frequent Statistical Instruments Train: Determine Individuals’ Statistical Expertise and Course Targets Lecture 2: Apply Statistics to Specification Setting Train: Setting Statistical Based mostly Specs Lecture three: Regression evaluation and variance parts Lecture four: Implement Design of Experiments (DOE) Train: Mock Experimental Design Day 2: Agenda Lecture 5: Validate your Testing Strategies utilizing Statistics Train: Evaluation of a Methodology Validation Research Together with Protocol Growth Lecture 6: Trending Evaluation Train: Assessment and Critique a Pattern SPC Management Chart Lecture 7: Design a Statistically Sound Sampling Plan Train: Create a Mock Sampling Plan Lecture eight: Statistically Analyze Annual Product Assessment (APR) Information Train: Apply Discovered Statistical Methods to Actual-World Information Dialogue: Wrap-up Query and Reply Session For whom: This course is developed to supply worthwhile help to all regulated corporations that want to know their processes together with corporations: a. Medical System b. Diagnostic c. Supervisors d. Pharmaceutical e. Biologics fields The staff who will profit embody: a. Growth Scientists b. Analytical Methodology Growth c. QA/QC personnel About GlobalCompliancePanel: GlobalCompliancePanel (GCP) is a specialised COMPANY providing from NetZealous LLC, a Know-how and Enterprise Course of Options and Providers Firm registered in Fremont, CA. It’s a fountainhead for Steady Skilled Schooling, compliance coaching and consulting. GCP provides a broad vary of top of the range regulatory and compliance-related companies referring to Medical Gadgets, Pharmaceutical, FDA, Meals, PCI industries, and SOX. A few of the Governing Areas its webinars cowl are GxP (Manufacturing/Medical/Lab), EU and ISO. These seminars are an extension of on-line trainings, at which GCP has performed round 700 webinars since inception on quite a lot of matters for these industries /verticals. Greater than 30,000 professionals have benefited from these trainings. GlobalCompliancePanel’s trainings are centered, versatile and tailor-made to the consumer’s want. That is the subsequent in a sequence of regulatory and compliance associated seminars that GlobalCompliancePanel has been organizing all around the US. Its earlier seminars have met with resounding success. GlobalCompliancePanel’s seminars have helped members attain their profession milestones. In bringing globally famend specialists within the subject of regulatory compliance and executives within the business collectively, GlobalCompliancePanel fosters a studying expertise. With trainings which can be centered and related, GlobalCompliancePanel seeks to function a bridge within the space of steady skilled schooling for regulatory and compliance-related fields. Value: $1,495.00 per participant. Reductions can be found for group participation within the following method: For 2 attendees: 10% low cost For 3 to 6 attendees: 20% low cost For seven to 10 attendees: 25% low cost For greater than 10 attendees: 30% low cost To avail the above group reductions, all of the members ought to register by making a single cost. Please be aware that the registration shall be closed two days (48 hours) previous to the beginning date of the seminar.

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