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How to Use and Validate Excel Spreadsheets to Ensure Compliance under FDA’s 21 CFR Part 11

How to Use and Validate Excel Spreadsheets to Ensure Compliance under FDA’s 21 CFR Part 11

Location: , United States
Category: Health and Medicine
Start Date: 04-03-2018 Last Day: 04-03-2018
Product Format: Live Webinar Presenter(s): Dr. David Lim, Ph.D., RAC, ASQ-CQA Conference Date: Tuesday, April 3, 2018 Time: 1:00 pm ET | 12:00 pm CT | 11:00 am MT | 10:00 am PT Duration: 60 minutes Price: $227.00 Join this session with expert speaker Dr. David Lim and learn how to adequately develop and implement Excel spreadsheet computer system validation in your organization in compliance with FDA’s 21 CFR Part 11. You will get in-depth insights to improve your awareness in order to better implement Part 11 and computer system validation requirements to avoid citations in 483s and warning letters.…
2018 Case Management: Complying with the Conditions of Participation and Other Regulatory Requirements

2018 Case Management: Complying with the Conditions of Participation and Other Regulatory Requirements

Location: , United States
Category: Health and Medicine
Start Date: 04-03-2018 Last Day: 04-03-2018
Product Format: Live Audio Conference Presenter(s): Toni G. Cesta, Ph.D., RN, FAAN Conference Date: Tuesday, April 3, 2018 Aired Time: 1:00 pm ET | 12:00 pm CT | 11:00 am MT | 10:00 am PT Length: 60 minutes Price: $227.00 In this session, industry veteran Toni G, Cesta will help you understand how to maintain compliance in a variety of areas directly related to utilization management and discharge planning. You’ll learn how to survive Joint Commission and CMS audits that are scrutinizing hospitals’ and case management departments’ compliance with the Conditions of Participation and other regulatory requirements. For Registration, visit…
FDA FSMA Sanitary Transportation Compliance Standards for Shippers, Carriers and Receivers

FDA FSMA Sanitary Transportation Compliance Standards for Shippers, Carriers and Receivers

Location: , United States
Category: Business and Economics
Start Date: 04-03-2018 Last Day: 04-03-2018
Product Format: Live Webinar Presenter(s): Dr. John Ryan, PhD, PCQI Conference Date: Tuesday, April 03, 2018 Time: 1:00 pm ET | 12:00 pm CT | 11:00 am MT | 10:00 am PT Duration: 70 minutes Price: $227.00 Join this session with expert speaker John Ryan, PhD, PCQI to learn everything you need to know about complying with the FSMA rules in an information-packed education session. John will whittle down all the actions you need to take, including management, sanitation, temperature, traceability, and prevention standards. Learn proper procedures and documentation for sanitation and temperature controls that meet and validate sanitary food…
2nd Clinical Trial Financial Management Summit

2nd Clinical Trial Financial Management Summit

Location: , United States
Category: Health and Medicine
Start Date: 04-04-2018 Last Day: 04-05-2018
ExL Events' 2nd Clinical Trial Financial Management Summit, convening on April 4–5, 2018 in Philadelphia, is designed to provide attendees with innovative solutions that deliver on-budget clinical trials using real-world data. Attendees will learn to manage contracts and negotiations with outsourcing partners and vendors; balance savings, quality, and speed in the selection of CROs and vendors; and pinpoint best practices for funding clinical trials through grants and government. Our fantastic, high level speaking faculty will tackle the all of these challenges and more during this two-day event. URLs: Brochure: https://go.evvnt.com/193735-1?pid=154 Booking: https://go.evvnt.com/193735-2?pid=154 Time: 8:00 am to 5:00 pm Prices: Early…
HIPAA Risk Analysis-Risk Management - Explained & Demonstrated

HIPAA Risk Analysis-Risk Management - Explained & Demonstrated

Location: , United States
Category: Health and Medicine
Start Date: 04-04-2018 Last Day: 04-04-2018 Deadline for abstracts: 04-03-2018
Training Options Duration: 60 Minutes Wednesday, April 4, 2018 | 10:00 AM PDT | 01:00 PM EDT Overview: This webinar for HIPAA Covered Entities and Business Associates will explain: What a complete HIPAA Risk Analysis - Risk Management program is and how to do one How to automate, simplify, document and complete your HIPAA Risk Analysis - Risk Management by an interactive, intuitive process: To identify and analyze Risks to all Protected Health Information (PHI) - not just Electronic Protected Health Information (EPHI) Manage Identified Risks Implement your specific, customized Risk Management Plan Archive your Risk Analysis - Risk Management-…
Palo Alto Networks: Get Hands-on with the VM-Series on Microsoft Azure

Palo Alto Networks: Get Hands-on with the VM-Series on Microsoft Azure

Location: , United States
Category: Engineering and Technology
Start Date: 04-04-2018
Next-Generation Security on Microsoft Azure There will be food and drinks, colleagues, and many security experts to network with. Hope to see you there! Price: price 1: USD 0 Time: 11:30 am to 3:00 pm
Discussion on Raw Material Methods and Specifications

Discussion on Raw Material Methods and Specifications

Location: , United States
Category: Health and Medicine
Start Date: 04-04-2018 Last Day: 04-04-2018 Deadline for abstracts: 04-03-2018
Overview: Based on knowledge of the active and inactive ingredient's function and role in the finished dosage form, Compendia methods and specifications are clearly accepted by third parties and regulatory agencies. Why should you Attend: The FDA has Approved hundreds of inactive ingredients for thousands of products with various dosage forms (routes of administration). The quantities and quality of each inactive ingredient is critical to the function and design of the final product formulation. Areas Covered in the Session: Description of the API and excipient manufacturing process and facility The supplier's commitment to conforming to appropriate excipient GMP requirements Characterization…
Veterinary Hospital Infect. Control and Antimicrob. Stewardship

Veterinary Hospital Infect. Control and Antimicrob. Stewardship

Location: , United Kingdom
Category: Health and Medicine
Start Date: 04-04-2018 Last Day: 04-04-2018 Deadline for abstracts: 04-04-2018
Challenges in Veterinary Hospital Infection Control and Antimicrobial Stewardship. Course Objectives: The objectives are to promote hospital infection control and antimicrobial stewardship in small animal practice and to educate a new generation of veterinary infectious disease specialists to be able to develop and implement infection control programmes (ICPs) and antimicrobial stewardship programmes (ASPs). Postgraduate education in this area is regarded as one of the key missions of ESGVM in order to meet the current public and animal health concerns related to the occurrence of multidrug-resistant bacteria and the increasing demand for responsible antibiotic use in veterinary medicine. The course will…
Designing and Using KPIs and Performance Dashboards

Designing and Using KPIs and Performance Dashboards

Location: , United States
Category: Business and Economics
Start Date: 04-04-2018 Last Day: 04-04-2018 Deadline for abstracts: 04-04-2018
OVERVIEW Organizational design improvements and technology advances have offered leadership an opportunity to provide process managers and decision makers at all levels of the organization with relevant information reporting in the form of right-timed dashboards to help them better manage and make quicker, more accurate decisions. It’s time for your team to take advantage of this progress. WHY SHOULD YOU ATTEND We need our leaders to be effective in deploying our resources and guiding our operations to reach our goals in the most effective way. We need everyone to understand our mission and strategy so we can be sure we…
Reporting Your Credit Data : E-Oscar, METRO2, FCRA/FACTA and CFPB Compliance

Reporting Your Credit Data : E-Oscar, METRO2, FCRA/FACTA and CFPB Compliance

Location: , United States
Category: Business and Economics
Start Date: 04-04-2018 Last Day: 04-04-2018 Deadline for abstracts: 04-04-2018
OVERVIEW Understand your potential legal risk and compliance obligations with respect to consumer credit reporting. Many financial institutions which furnish consumer credit information on a periodic basis to Credit Reporting Agencies (CRAs) experience challenges in furnishing data in the Metro 2® format. Most credit reporting disputes are handled through the E-OSCAR/ACDV system, which has had recent updates that affect data furnishers' legal obligations in regard to these disputes. This is an active area of litigation and regulatory scrutiny that is consistently being reviewed by examiners and regulators. WHY SHOULD YOU ATTEND This webinar will help attendees better understand their potential…
Consumer Marketing 2018

Consumer Marketing 2018

Location: , United States
Category: Business and Economics
Start Date: 04-05-2018 Last Day: 04-06-2018
Expectations have never been higher: Marketing leaders must be brand stewards at every stage and touchpoint in the customer lifecycle, in every channel, on more and more platforms. You must prove out your strategy on a sea of hard data. And you must deliver. Not the soft metrics of views, impressions, clicks and likes, but hard benchmarks of revenue growth and business performance. Are you ready? Join us to learn how to navigate your marketing strategies and practices away from traditional, increasingly ineffective marketing and advertising, and towards intelligent, personalized, and conversational relationships that drive real-world results. Time: 8:00 am…
Evolution of the Quality Management System - How to go from Surviving to Thriving 2018

Evolution of the Quality Management System - How to go from Surviving to Thriving 2018

Location: , United States
Category: Health and Medicine
Start Date: 04-05-2018 Last Day: 04-06-2018 Deadline for abstracts: 04-04-2018
Course "Evolution of the Quality Management System - How to go from Surviving to Thriving" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Using lecture, discussion, and exercises, this 2 day seminar will focus on taking your QMS from surviving to thriving. We'll move from understanding the regulatory requirements, how to create your QMS structure, process thinking, and developing your improvement strategy. We'll discuss tools and techniques for improvement and how to measure your progress. Why you should attend: Many companies struggle to establish and maintain a…
A Risk Based Strategy for the Development & Validation of and Validation of Analytical Methods with a QbD Approach

A Risk Based Strategy for the Development & Validation of and Validation of Analytical Methods with a QbD Approach

Location: , United States
Category: Education
Start Date: 04-05-2018 Last Day: 04-06-2018 Deadline for abstracts: 04-03-2018
Course "A Risk Based Strategy for the Development & Validation of and Validation of Analytical Methods with a QbD Approach" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Following the initial development, the steps further continues thru optimization and subsequently to Validation, leading to the understanding of Validation Parameters and their generic definitions. Guidance from EP, USP, ICH Q2 (R)1, AOAC etc. will be discussed. The presentation continually builds on from a conceptual level to practical applications leading to data handling, Data Integrity, Validation Protocol and other…
eCTD Submissions of IND/NDA to the US FDA, EU and Canada 2018

eCTD Submissions of IND/NDA to the US FDA, EU and Canada 2018

Location: , United States
Category: Health and Medicine
Start Date: 04-05-2018 Last Day: 04-06-2018 Deadline for abstracts: 04-03-2018
Course "eCTD Submissions of IND/NDA to the US FDA, EU and Canada" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies. Reformatting for multiple submissions is substantially limited. The CTD has improved the regulatory review processes and enabled implementation of good…
Validation for the New FDA Inspections

Validation for the New FDA Inspections

Location: , United States
Category: Education
Start Date: 04-05-2018
Overview: How to conduct a software validation program that will satisfy FDA requirements and produce a safe product. Why should you Attend: There are additional requirements,analyses and tests that FDA feels are necessary to prevent user injuries. These requirements were developed after analysis by the FDA of many recalled medical devices. In this webinar you will learn the requirements in addition to functional tests that are required to produce a validated software product. Areas Covered in the Session: Software Validation more than Testing Requirements Traceability Risk Analysis Unit,Integration and System Testing Algorithm Validation Challenges to the Software Configuration Management Who…
Representations & Warranties in Physician Practice Acquisitions

Representations & Warranties in Physician Practice Acquisitions

Location: , United States
Category: Health and Medicine
Start Date: 04-05-2018 Last Day: 04-05-2018
Product Format: Live Webinar Presenter(s): Steven T. Lawrence, MBA, JD, LLM Conference Date: Thursday, April 5, 2018 Aired Time: 1:00 pm ET | 12:00 pm CT | 11:00 am MT | 10:00 am PT Length: 60 minutes Price: $227.00 Join this session with healthcare attorney Steven Lawrence, JD, MBA, LLM where he will instruct you on the current state of representations and warranties in physician practice transactions. You will learn best practices for due diligence and current trends in indemnification. Lawrence will break down standard representations and warranties in physician practice transactions and how those representations tie to both due…
Blue Sky Social

Blue Sky Social

Location: , United States
Category: Business and Economics
Start Date: 04-05-2018 Last Day: 04-05-2018
The event will take place at Highline Bar and Lounge in River North. Check out their amazing space and meet other creative Chicagoans who share your entrepreneurial spirit and passion for new ideas. Price General Admission: USD 3.50 Time: 6:00 pm - 8:00 pm
Planning, Managing and Delivering Organizational Change: The 7-Step Process That Keys Success

Planning, Managing and Delivering Organizational Change: The 7-Step Process That Keys Success

Location: , United States
Category: Business and Economics
Start Date: 04-06-2018 Last Day: 04-06-2018 Deadline for abstracts: 04-06-2018
The TrainHR webinar is approved by HRCI and SHRM Recertification Provider. Overview: Change is inevitable. But when changes are made, many employees lack the broader knowledge of why new systems and structures are necessary. As a result, frontline managers and human resources professionals must partner together and help organizations lead and manage change. This case-study-based webinar will prepare managers responsible for facilitating or implementing change initiatives, identify key business drivers that typically underlie the need for change. You'll learn how to work with key stakeholders in ways that build support and ensure positive outcomes for your bottom line. Why should…
Medical Device Single Audit Program Preparation

Medical Device Single Audit Program Preparation

Location: , United States
Category: Health and Medicine
Start Date: 04-06-2018
Overview: The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale. Why should you Attend: Today with a single audit, it is possible for a medical device manufacturer to satisfy the quality management system requirements of Australia, Brazil, Canada, Japan and the USA! This is the benefit of the Medical Device Single Audit Program, or MDSAP. However, there are some vital considerations before embarking upon this approach to satisfying the regulators of five major markets. Areas Covered in the…
Quality Audit According to Gxp-GMP Requirements 2018

Quality Audit According to Gxp-GMP Requirements 2018

Location: , United States
Category: Education
Start Date: 04-06-2018
Overview: GMP regulations describe required quality management system for production and testing of products in these regulated industries. The purpose of the GMP regulations is to ensure that a product is safe and meets its intended use. Why should you Attend: Learn about GxP/GMP regulations and how they affect quality management system and quality audit. Learn about different types of quality audits and how to properly prepare for them, what actions you need to take to ensure that your organization will pass an audit. Areas Covered in the Session: GxP/GMP Framework Quality Management System Quality Audit Who Will Benefit: Quality…

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