Management conference and seminar

The Healthcare Quality Improvement Act: Achieving Immunity in Your Peer Review Process

Ref: 29193 Wednesday April 24th, 2019 - Palo Alto ^US

Editorial In this training program, attendees will gain an understanding of how the HCQIA protects your organization and on those who participate in the peer review process in your organization. They will also gain an appreciation of the actions that are required to perfect HCQIA immunity. ...

Contemporary Case Management Staffing and Models: Best Practices in the Era of Value-Based Purchasing

Ref: 29195 Wednesday April 24th, 2019 - Palo Alto ^US

Editorial This webinar will review contemporary, best practice, case management models including descriptions of the two most commonly used models, the key differences between the models, as well as how they should be designed and structured. The webinar will also discuss the steps needed to re-...

CDISC Mapping 3: Compare and Contrast SDTM and ADaM Steps

Ref: 29196 Wednesday April 24th, 2019 - Palo Alto ^US

Editorial This training program will assist anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Professionals in the ...

The Healthcare Quality Improvement Act: Achieving Immunity in Your Peer Review Process

Ref: 29363 Wednesday April 24th, 2019 - Palo Alto ^US

Editorial In this training program, attendees will gain an understanding of how the HCQIA protects your organization and on those who participate in the peer review process in your organization. They will also gain an appreciation of the actions that are required to perfect HCQIA immunity. ...

Contemporary Case Management Staffing and Models: Best Practices in the Era of Value-Based Purchasing

Ref: 29364 Wednesday April 24th, 2019 - Palo Alto ^US

Editorial This webinar will review contemporary, best practice, case management models including descriptions of the two most commonly used models, the key differences between the models, as well as how they should be designed and structured. The webinar will also discuss the steps needed to ...

CDISC Mapping 3: Compare and Contrast SDTM and ADaM Steps

Ref: 29376 Wednesday April 24th, 2019 - Palo Alto ^US

Editorial This training program will assist anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Professionals in the ...

Implementing a Quality Management System

Ref: 29377 Wednesday April 24th, 2019 - Palo Alto ^US

Editorial This GLP quality system webinar provides a general overview of the Proposed Rule, a GLP QMS and its implementation, GAP analysis, Plan-Do-Check-Act cycle, process control and optimization theory and quality audits are utilized for the analysis of an existing QMS and the potential ...

Implementing a Quality Management System

Ref: 29518 Wednesday April 24th, 2019 - Palo Alto ^US

Editorial This GLP quality system webinar provides a general overview of the Proposed Rule, a GLP QMS and its implementation, GAP analysis, Plan-Do-Check-Act cycle, process control and optimization theory and quality audits are utilized for the analysis of an existing QMS and the potential ...

Creating a Risk-based Supplier Management program

Ref: 29519 Wednesday April 24th, 2019 - Palo Alto ^US

Editorial This webinar on supplier controls will provide you the information you need to assure your supplier management program is in compliance with the latest FDA, European and international guidelines requiring a risk-based supplier management program. We will look at how to improve your ...

Human Error Investigations, Root Cause Determination and CAPA Effectiveness

Ref: 29194 Thursday April 25th, 2019 - Palo Alto ^US

Editorial This training program will offer attendees an understanding of human error, its factors and causes. The program will also identify the regulatory and business importance of human error prevention and define the process to manage human error deviations. Objectives Understand ...

How to Manage Your Vendors in Clinical Research

Ref: 29373 Thursday April 25th, 2019 - Palo Alto ^US

Editorial This vendor management webinar will show you how to choose the right vendor, onboarding and set up, manage vendor performance, manage issues and ensure compliance with current FDA regulations and ICH guidelines and have a smooth-running clinical study. Objectives Sponsors are ...

Human Error Investigations, Root Cause Determination and CAPA Effectiveness

Ref: 29374 Thursday April 25th, 2019 - Palo Alto ^US

Editorial This training program will offer attendees an understanding of human error, its factors and causes. The program will also identify the regulatory and business importance of human error prevention and define the process to manage human error deviations. Objectives Understand ...

Drug Master Files (DMFs) - Understanding and Meeting Your Global Regulatory and Processing Responsibilities

Ref: 29375 Thursday April 25th, 2019 - Palo Alto ^US

Editorial This DMFs (Drug Master Files) training will discuss the current review and enforcement climate within FDA and the manner in which drug master files (DMFs) are reviewed by FDA personnel. Besides the US, the use of DMFs in the EU, Canada and Australia will also be discussed. ...

Conducting Effective Investigations of Out of Specification and Atypical Laboratory Results

Ref: 29520 Thursday April 25th, 2019 - Palo Alto ^US

Editorial This training on pharmaceutical laboratory OOS investigations will explain how to recognize and address atypical or out of specification results, using approaches which have been recommended by regulatory authorities, performing appropriate ...

The Brazilian Reimbursement System

Ref: 29521 Thursday April 25th, 2019 - Palo Alto ^US

Editorial In this webinar attendees will learn the legal and regulatory framework for reimbursement system in Brazil to have better and effective result when marketing with medical and drug product in Brazil.   Objectives How does the Reimbursement System ...

Good Documentation Guideline (Chapter <1029> USP)

Ref: 29522 Friday April 26th, 2019 - Palo Alto ^US

Editorial This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain ...

Quality Management and Quality Audit According to GxP/GMP Requirements

Ref: 29533 Friday April 26th, 2019 - Irvine ^US

Editorial In this webinar, the framework of GxP/GMP regulations, quality management system, and quality audit will be described. Attendees will 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 ...

Compliance Measures for Case Managers

Ref: 29372 Thursday May 02nd, 2019 - Palo Alto ^US

Editorial   This program will review the compliance issues that most greatly impact your practice such as the 2-midnight rule, the NOTICE Act, HINNs, the important message from Medicare and others. The Joint Commission is now monitoring these issues when they have deemed status from ...

Handling OOS Test Results and Completing Robust Investigations

Ref: 29536 Thursday May 02nd, 2019 - Palo Alto ^US

Editorial This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which ...

Stability Studies and Estimating Shelf Life

Ref: 29538 Monday May 06th, 2019 - Palo Alto ^US

Editorial In this webinar attendees will learn the useful methods and techniques for conducting a stability study and analyzing the resulting data for estimating shelf life. This webinar will provide the answers to help participants immediately apply the presented methods. The interpretation ...

Design History Files and Technical Files/Design Dossiers - Meeting U.S. FDA CGMPS and the EU's MDD Requirements

Ref: 29562 Tuesday May 07th, 2019 - Palo Alto ^US

Editorial This 90-minute webinar will examine in detail the U.S. FDA and EU MDD requirements for DHFs, DMRs, DHRs, and TF/DDs - their formats, content, and their commonalities, differences, interrelationships, and similarities.   Objectives Global companies must ...

Effective Records Management and Document Control for Medical Devices

Ref: 29563 Tuesday May 07th, 2019 - Palo Alto ^US

Editorial In this webinar attendees will learn the QSR and ISO 13485 requirements for document control and the ideas associated with the development and control of quality documentation. Also attendees will get knowledge on methods and practices that will improve the clarity and control of ...

Production and Process Controls - Ensuring your medical device conforms to its specifications

Ref: 29564 Wednesday May 08th, 2019 - Palo Alto ^US

Editorial This presentation will cover the FDA regulations (21 CFR Subpart G Section 820.70) regarding production and process controls and how each requirement listed within the regulation can be addressed. We’ll go over examples of documentation you can use to fulfill the requirements of this ...

Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance

Ref: 29565 Thursday May 09th, 2019 - Palo Alto ^US

Editorial Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time. Objectives This course will train attendees on best practices to create a spreadsheet that is GxP compliant using Microsoft Excel. Attendees ...

GMP Environmental Monitoring for Pharmaceutical Clean Rooms

Ref: 29566 Tuesday May 14th, 2019 - Palo Alto ^US

Editorial This webinar will discuss various US and international regulatory requirements, testing requirements for environmental monitoring program, current air and surface monitoring for measurement of no-viable particulate, microbial contamination, contamination due to personnel (gowning ...