All Conferences

Overview: This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to greatly increase productivity. Areas Covered in the Session: Which data and systems are subject to Part 11 What Part 11 means to you, not just what it says in the regulation Avoid 483 and Warning Letters Explore the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation Ensure data integrity, security, and protect intellectual property Who Will Benefit: IT QA QC Laboratory Staff Managers GMP, GCP, GLP Professionals Speaker Profile: David Nettleton, is an FDA…

Erfahren Sie in unserem Webinar „Die Zwei um Zwölf“ wie Traps™ 5.0 - Advanced Endpoint Protection von Palo Alto Networks® eine einzigartige Kombination aus speziell zum Schutz vor Malware und Exploits entwickelten Methoden verwendet, um bekannte und unbekannte Bedrohungen zu stoppen, bevor sie einen Endpunkt beschädigen können. In unserem Webinar erklären wir Ihnen die Vorteile von Traps gegenüber herkömmlichen Antivirusprodukten: · Verhindert Cyberangriffe durch die vorbeugende Blockade bekannter und unbekannter Malware, Exploits und Zero-Day-Bedrohungen. · Schützt und befähigt Benutzer, ihre täglichen Aktivitäten unter Verwendung webbasierter Technologien auszuführen, ohne sich Gedanken um bekannte oder unbekannte Cyberbedrohungen machen zu müssen. · Automatisiert…

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…

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…

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…

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…

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…

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…

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

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…

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-…

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

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…

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…

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…

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…

Training Options Duration: 60 Minutes Tuesday, April 3, 2018 | 10:00 AM PST | 01:00 PM EST Overview: 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 you also have the proper policies and procedures in place. If audited or the subject of a compliance review you will be required to show the government you have all the necessary documentation in place for safeguarding patient Protected Health Information and indicate how you addressed all required privacy safeguards. This starts with the fundamentals…

The TrainHR webinar is approved by HRCI and SHRM Recertification Provider. Overview: This Webinar will cover withholding rules, reciprocity and residency definitions. Why should you Attend: To better understand the laws in each state and the tax guidance on how to determine taxation when employees live in one state and work in another. Or for employees that work in multiple states for travel for work.Also other state laws that affect payroll will be discussed. Areas Covered in the Session: Residency Reciprocity Agreements Resident/Non Resident Withholding Rules Evaluating taxation for multiple states What wages are subject to taxation? Withholding compliance issues…

The TrainHR webinar is approved by HRCI and SHRM Recertification Provider. Overview: Have you ever considered the impact that soft skills can have on effective leadership? Most leaders understand that it takes more than technical knowledge and product expertise to successfully develop and lead a team. What do soft skills boil down to? How to appropriately interact with your employees within different situations. But how do you balance soft skills with the also-important focus on bottom-line results? What are soft skills and where do you find them? Recognizing the importance of soft skills in successful leadership is instrumental in your…

OVERVIEW The key to writing an effective audit observation is having a comprehensive structured process. The Institute of Internal Auditors recommends a process known as the 5Cs: • Criteria • Condition • Cause • Consequences (Effect) • Corrective Action (Recommendation) As you develop conclusions, findings, and recommendations, you must present them to your client in a logical, complete, and objective way. This process provides an easy way to consistently develop and present your observations. The components in this process include all the information you will need to inform and persuade. Developing this process can be an important tool for completing…