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Examination of Laboratory, Medical and Device issues including Performance, Risk and Validation following Regulatory and ICH Statistical Guidelines (NTZ)
Examination of Laboratory, Medical and Device issues including Performance, Risk and Validation following Regulatory and ICH Statistical Guidelines *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! This course is designed to introduce to individuals the understanding and interpretation of the statistical concepts one uses when investigating quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits, and process and quality control. One also considers ICH Q8 and Q9. These techniques covers both clinical and laboratory applications. This applies to many areas such as stability testing, outlier analysis and risk management. It is not a course in statistics but introduces the participant to an applied approach to the statistical techniques one uses, how they are reasonably interpreted. One will address the various challenges facing pharmaceutical and biotechnology companies when it comes to quantifying results in a meaningful interpretable manner through tabulations and graphical presentations. In this two day workshop seminar one will learn the different regulatory agencies expectations of the quantification and development of a sound statistical monitoring of process control that are utilized, effective, and efficient. Participants will become familiar with the important aspects of the statistical methods and learn how these guidelines are applied in practice.   Areas Covered in the Session: Upon completing this course participants should be able to: Evaluate linear quantitative measurement procedures and sources of error. Distinguish the difference between confidence and tolerance intervals Evaluate the appropriateness of the effect of sample size in given procedures. Evaluate laboratory/clinical quality control based on risk management Interpret statistical process control Distinguish between FDA requirements and ICH guidelines Who Will Benefit: This course is designed for people responsible for developing, maintaining and/or improving clinical and laboratory monitoring programs and interpreting the results from such. This includes individuals that have data monitoring responsibilities. The following personnel will benefit from the course: Quality Managers Quality Professionals Assay Development Scientists Research Scientists Data Analysts Laboratory Data Managers AGENDA Day 1 Schedule Registration Process: 8:30 AM - 9AM Session Start Time: 9AM Lecture 1: Overview of ICH Methodology Lecture 2: Introduction to the simple regression model Interpreting the slope and intercept in validation procedures Residual analysis and error detection Stability and Potency issues Lecture 3: Outlier strategies using the linear model in calibration methods Imputation techniques for missing data Outlier strategies for non normal or ranked data Consequences of outlier elimination/substitution Sample size and analysis issues Lecture 4: Confidence and tolerance bounds on risk models Parametric and non parametric (non normal data) procedures Exact computational techniques Day 2 Schedule Lecture 1: Discussion of risk management in general Traditional risk management strategies in clinical settings Predictive models in risk assessment Discussion of the Design Space Risk Management in pre-analytical phase of laboratory testing Lecture 2: Introduction to validation of models in hazard assessment and risk management Demonstration of laboratory Validation procedures Bivariate models and confusion matrices and derived statistics ROC plot Lecture 3: Statistical process laboratory control and capability Normal and non normal data procedures Evolutionary Operations Process Lecture 4: Confidence and tolerance bounds on limits of risk SPEAKER Alfred A. Bartolucci Dr. Al Bartolucci is Emeritus Professor of Biostatistics at the University of Alabama where he also serves as a Senior Scientist at the Center for Metabolic Bone Diseases, AIDS Research Center and Cancer Center. He previously served as Chairman of the Department from 1984 through 1997. He has also taught Statistical Software courses involving Data Exploration, ANOVA/Regression and Design of Experiments. His teaching experience includes areas such as, Clinical Trials, Survival Analysis, Multivariate Analysis, Regression Techniques and Environmental/Industrial Hygiene Sampling and Analysis, Bayesian Statistics, and Longitudinal Data Analysis. Dr. Bartolucci received his PhD in Statistics from the State University of New York at Buffalo and his MA in Mathematics from Catholic University, Washington DC, and his BA in Mathematics from Holy Cross. Please contact the event manager Marilyn (marilyn.b.turner@nyeventslist.com ) below for:- Multiple participant discounts- Price quotations or visa invitation letters- Payment by alternate channels (PayPal, check, Western Union, wire transfers etc)- Event sponsorshipsNO REFUNDS ALLOWED ON REGISTRATIONSService fees included in this listing.-----------------------------------------------------------------This event is brought to you by:Netzealous LLC - NewYorkEventsListhttp://www.NyEventsList.comhttp://www.BostonEventsList.comhttp://www.SFBayEventsList.com-----------------------------------------------------------------MYL180602CEV MYL180615CHK MYL180712UPR

When: Aug 20, 2018 8:30AM in Revere, MA
Showcase Cinemas Event Cinema Presents “Jaws”

Watch as a great white shark that haunted your dreams as a kid arrives and wreaks havoc on the shores of a New England beach town. Will a part-time sheriff, a marine biologist and an old seafarer be able to hunt the monster down? They’re going to need a big boat.

Visit showcasecinemas.com to reserve your tickets to see “JAWS” today.

Showcase Cinemas Bring Backs is an Event Cinema series celebrating cinema by bringing back movie favorites each month for audiences to enjoy again.

When: Aug 23, 2018 7:30PM in Revere, MA
Cost: $11
Trio Parada Dura
When: Aug 24, 2018 9pm in Revere, MA
Keep Revere Beach Clean
Sponsored by: MA Department of Conservation and Recreation
Minimum age: 18
Revere Beach is America’s first public beach. It is a destination for tourists and locals alike, and yet is often littered with trash from local restaurants and marine debris. The MA Department of Conservation and Recreation works hard to maintain the beach, but they need our help to re . . .

When: Aug 25, 2018 10am in Revere, MA
Showcase Cinemas Event Cinema Presents “Jaws”

Watch as a great white shark that haunted your dreams as a kid arrives and wreaks havoc on the shores of a New England beach town. Will a part-time sheriff, a marine biologist and an old seafarer be able to hunt the monster down? They’re going to need a big boat.

Visit showcasecinemas.com to reserve your tickets to see “JAWS” today.

Showcase Cinemas Bring Backs is an Event Cinema series celebrating cinema by bringing back movie favorites each month for audiences to enjoy again.

When: Aug 26, 2018 1pm in Revere, MA
Cost: $11
☆░ ScapeOrNothing presents- Vybz By The Beach Each and every sunday ! ☆░
☆░ ScapeOrNothing Presents Vybz By The Beach each and every sunday Music by- #SoundsScape and Special guest DJ's Every Sunday.  Live grill, Serving carribbean food For Birthday Celebrations, Graduations and more contact- 857-205-7282, 617-510-5592 Venu- 63 Revere Beach BLVD, Revere MA-02151   ☆░ #Vybzbythebeach  #scapeornothing

When: Aug 26, 2018 4pm in Revere, MA
Reconhecendo Talentos & Despertando Sonhos
Encontro para Mulheres!!! Uma pessoa de sucesso conhece as suas habilidades e acredita no seu potencial, você conhece os suas habilidades? Sabe o quanto voc��é capaz? Que tal fazer aquela auto-avaliação? Venha estar conosco no encontro de Mulheres Vencendo Desafios! Sou Cristiane Romero  formada nos EUA, bacharel em Psicologia, Coach de Vida e Analista de Perfil Comportamental) juntamente com Marcela Loureiro (Coach de Vida e Facilitadora de Constelação Familiar). Vamos juntas nos potencializar e transformar esses sonhos em planos de ação utilizando todas as nossas habilidades!   FAQs   What are my transportation/parking options for getting to and from the event? Estacionamento grátis dentro do hotel.   How can I contact the organizer with any questions? Cristiane Romero 857 888 9492  Marcela Loureiro 857 236 3031 What's the refund policy? Devolução integral do valor do ingresso em caso de cancelamento com 24 horas de antecedência.  

When: Aug 27, 2018 7pm in Revere, MA
Showcase Cinemas Event Cinema Presents: André Rieu

The “King of Waltz’” 2018 Maastricht Concert: Amore – My Tribute to Love will be screened at select Showcase Cinemas on Tuesday, August 28th. Comfortably sit back, relax and enjoy re-living the concert up close on the big screen!


Reserve your seats today at https://www.showcasecinemas.com/movie/andre-rieus-2018-maastricht-concert-amore-my-tribute-love!


Showcase Cinemas Event Cinema expands the movie-going experience beyond the latest blockbuster films and brings alternative content to the big screen including a wide range of compelling and unique live and recorded entertainment.

When: Aug 28, 2018 7pm in Revere, MA
Cost: $18
8/30 Seascape Fundraiser to benefit Crohn's & Colitis Foundation (Revere, MA)
Join us at the Point of Pines Yacht Club for a one-of-a-kind art party in honor of Mason Wetmore, a 12-year-old Crohn's Warrior and son of Jill Simmons-Wetmore. Seascape Creations artist Maria Robertson will help you create a stunning 8x10 Seascape Window using sea glass, starfish, sand dollars, and sea-inspired accents. Participants can take home and fuse their own pieces with Seascape Creation's Finishing Kit + Instructions. For every ticket sold, Seascape Creations will donate $10 to the Crohn's & Colitis Foundation along with up to 20% of the proceeds from sales from the artist's gallery.  FAQs Do I need to bring a ticket? No paper necessary! We will check you and your guests in by name upon arrival. If you ordered multiple tickets for your friends and your friends arrive before you, just have your friends check in under your name and they will be all set.  What will I learn during the workshop? The purpose of the workshop is to give you the supplies and guidance to design your own 8x10 seascape window. Due to special requirements, we cannot demonstrate or conduct fusing onsite. However, participants will take home a finishing kit and instructions that enable them to complete a finished piece. But I'm not artistic! Not artistic? No problem! When you are working with sea glass and other natural treasures, it's easy to de-stress, unwind, and create a beautiful masterpiece. The instructor will walk around and answer any question you may have. If you need more hands-on guidance or advice, we can help! We will keep you on track to completion of your masterpiece.  Will I be able to finish my piece at the workshop? Due to restaurant health codes, we are unable to conduct fusing onsite. Instead, you will complete the design of your piece at the venue and we will help you prep for safe transport. You will take your piece home along with our easy-to-use finishing kit. What is provided? All supplies are provided. However, you are welcome to bring your own sea glass and beach treasures to personalize your creation. Can I bring my own frame? The 8x10 frames provided are specially prepared for this process. As a result, we require that you use our frames for this workshop. What design will we be making? The design is entirely up to you. For ideas, visit www.seascapecreations.com or https://www.facebook.com/seascapewindows/. Samples and templates will also be provided at the event. How do I ensure that my design will not shift during transport? By gluing your design during your workshop, you are helping to ensure that your design will stay in tact. Spray adhesive is used to secure smaller items that cannot be glued.   Can I order food and drinks at the event? Absolutely!  The Point of Pines Yacht Club bar will be open at 6:30 pm and the Seaside Cafe will open 6:30-9:30 pm with an appetizer and dinner menu. How does seating work?   Seating is on a first come, first served basis. So if you have a few friends that you want to sit with, you probably want to get to the venue early so you can secure seats next to each other. What if I need to cancel? Can I get a refund? A lot of preparation goes into arranging for a Seascape event at a specific venue, and most events sell out. For these reasons, a minimum of 48 hour notice must be given for a full refund. All requests must be in writing: seascapecreations@yahoo.com. If you cancel less than 48 hours in advance, we can credit your registration for another night. That credit must be used WITHIN 60 DAYS. No shows will NOT be credited for another day. Thank you for understanding. Can someone come in my place? No problem! There is no need to make any changes to your registration. Simply have your friend give your name upon check-in.  Do you take photos at the event? Yes, we love taking photographs of our guests and their beautiful creations and sharing them on social media (we typically share on our Facebook page the next day). We also encourage our guests to take photos of themselves and their masterpieces with their family and friends. If for any reason you do not want to be included in any photos, please let the instructor know at the beginning of class and we would be happy to honor your request. Will you ever cancel an event? We hope to never cancel, however an event may be cancelled due to inclement weather or if there are less than 5 people registered. In the event that Seascape Creations has to cancel an event, we will make every attempt to notify every registered guest in advance. Guests will be given the option of rescheduling, or we will glady provide a refund.

When: Aug 30, 2018 7pm in Revere, MA
Music For All
When: Aug 31, 2018 8:30PM in Revere, MA