World Conference Calendar

32676 Conferences

Health and Medicinerss


The 5th Annual Operational Excellence for Pharmaceuticals, Biotech and Medical Devices

The 5th Annual Operational Excellence for Pharmaceuticals, Biotech and Medical Devices

Location: , United Kingdom
Category: Health and Medicine
Start Date: 12-06-2010 Last Day: 12-08-2010
The 5th Annual Operational Excellence for Pharmaceuticals, Biotech and Medical Devices will address the key issues from initial analysis and building of your operational excellence strategy within manufacturing, R&D and clinical environments to development of the right tools and successful implementation. Internationally-Renowned Experts Share Their Insights! Speakers already confirmed include: - Daniel Sikkema, Senior Director, Global Operations, Sanofi-Pasteur - Stephen Walker, Associate Director and Lean Sigma Black Belt, AstraZeneca - Chet Damania, Master Black Belt, Johnson & Johnson - Celia Banks, Global Continuous Improvement Lead, Pfizer - Dawood Dassu, R&D Global Master Black Belt, AstraZeneca - Peter Lake, Manufacturing Improvement…
Teens Using Drugs: What To Know and What To Do

Teens Using Drugs: What To Know and What To Do

Location: , United States
Category: Health and Medicine
Start Date: 12-07-2010 Last Day: 12-07-2010
"Teens Using Drugs: What To Know and What To Do" is a FREE, ongoing, two-part workshop series designed to help participants learn to understand, identify and address adolescent alcohol/other drug problems. Part 1 is presented on the first Tuesday of each month from October through June, provides information on how to understand and recognize the signs of a teen substance abuse problem, and includes a short video. Part 2 is presented on the second Tuesday of each month from October through June, provides information on what should and should not be done when a teen substance abuse problem is recognized,…
Validating Excel and Word Applications Documents - Medical Device Webinar By ComplianceOnline

Validating Excel and Word Applications Documents - Medical Device Webinar By ComplianceOnline

Location: , United States
Category: Health and Medicine
Start Date: 12-07-2010 Last Day: 12-07-2010
This validation training will discuss FDA impacts and approaches for compliance for use of COTS (commercial off the shelf) office applications software, such as spreadsheets and word processing. Areas Covered in the Seminar: Tougher FDA and EU MDD Software V&V Expectations. Key COTS Software Apps V&V Requirements. Problem Areas. Product, Equipment/Process, QMS and Apps Software and Part 11 Requirements . Realistic Limits of Apps Software V&V. Suggested Approaches. How to Implement, Execute and Document. Proper Risk Allocation of Scarce Resources. Who Will Benefit: This webinar will provide valuable assistance to personnel in all regulated companies responsible for software validation under…
The 510(k) Submission: Requirements, Contents, and Options - Webinar By GlobalCompliancePanel

The 510(k) Submission: Requirements, Contents, and Options - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 12-08-2010 Last Day: 12-08-2010
Overview: This presentation will provide an understanding of how to get a device requiring a 510(k) submission to market quickly. Knowing when and how to properly submit a 510(k) for a device or change to a device is critical to a company's regulatory and financial health. Your goal is to get the 510(k) through the review process as quickly as possible. This presentation will also distinguish between the standard, special and abbreviated 510(k)s, and explain when each is appropriate. This course will describe the submission process and the contents required by the FDA for a successful submission. It will also…
The FDA's Working Group Reports, I & II - New Directions - Webinar By GlobalCompliancePanel

The FDA's Working Group Reports, I & II - New Directions - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 12-08-2010 Last Day: 12-08-2010
Overview: This webinar will examine the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what it (the FDA and industry) need to do internally. Examination of two recently published reports by the FDA's CDRH (devices) have identified major areas of concerns: 1) 510(k) Working Group's Preliminary Report and Recommendations, and 2) Task Force on the Utilization of Science in Regulatory Decision Making. Both Preliminary Reports and Recommendations were published August 2010, and stakeholders / industry is invited to comment. They recommend action on the part of both the FDA…
Logical Water System Validation - Clinical Research Webinar By ComplianceOnline

Logical Water System Validation - Clinical Research Webinar By ComplianceOnline

Location: , United States
Category: Health and Medicine
Start Date: 12-09-2010 Last Day: 12-09-2010
This Water system validation training will guide you how validation should be customized to your particular water system design and maintenance practices, what operational elements should be included in the microbial testing during validation and which ones need not be. Understanding the purpose of water system validation will allow you to see the fallacies of many standard protocol templates bred by tradition and do only what is appropriate for YOUR water system. Areas Covered in the Seminar: Why validate a water system? Basic ground rules for water systems before you validate them. Micro Test Method “validation”. Minimum validation expectations. How…
Audit Committee Responsibilities for Internal Controls - Webinar By GlobalCompliancePanel

Audit Committee Responsibilities for Internal Controls - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 12-14-2010 Last Day: 12-14-2010
Overview: With the advent of the Sarbanes-Oxley Act, audit committees are under increased scrutiny for helping management set the tone at the top and ensuring internal controls are documented and tested. As a matter of fact, the Audit Committee has the PRIMARY responsibility for oversight of internal controls. One thing audit committee member should expect is to have a clear understanding of their responsibilities in today’s regulatory environment. Why you should attend: In the wake of corporate failures and the Sarbanes-Oxley Act, great strides must be taken by Audit Committees to properly carry out responsibilities. A clear understanding of what…
Introduction to the safe use and storage of flammable liquids in laboratories and pharmaceutical manufacturing operations

Introduction to the safe use and storage of flammable liquids in laboratories and pharmaceutical manufacturing operations

Location: , United States
Category: Health and Medicine
Start Date: 12-14-2010
This OSHA webinar will specifically evaluate the topic from the viewpoint of a California facility identifying and explaining requirements of the California Fire and Building Codes as well as California OSHA. The course module will examine the basics of safely using and storing flammable liquids in pharmaceutical manufacturing and laboratory operations. The module will review the definitions of flammable liquids and survey priority topics of applicable Codes and Regulations. Key topics include review of proper storage containers and requirements for electrical classification of areas.
The Advantages of Linking Management Systems - Webinar By GlobalCompliancePanel

The Advantages of Linking Management Systems - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 12-15-2010 Last Day: 12-15-2010
Overview: It's important to improve the dialogue between financial, quality, IT and environmental management systems. Members of these management systems need to understand what the others do. Quality and environmental managers need to understand the language of finance and the effect of operations on the bottom line, while financial managers need to know how quality, environmental and IT managers can help improve results. In the long run there will be cost savings, continual improvement of processes and products and a greater understanding of each other’s work and responsibilities. Why you should attend: There are a number of reasons for attending…
Understanding Attribute Acceptance Sampling including Z1.4 and c=0 Plans - Webinar By GlobalCompliancePanel

Understanding Attribute Acceptance Sampling including Z1.4 and c=0 Plans - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 12-16-2010 Last Day: 12-16-2010
This course provides the attendees with the tools needed to understand and implement acceptance sampling. We explain the basis for sampling plans, the binomial distribution, and show how it helps us understand the sampling plan’s performance using the operating characteristic (OC) curve. Participants will gain a solid understanding of how the OC curve is built, how to use it, and how to identify some of the most important points on the curve, including the AQL and RQL points. The course also provides complete descriptions of three other important curves that help you understand a sampling plan. The average sample number…
ISO 13485 as a Quality Management System for Medical Devices - webinar By GlobalCompliancePanel

ISO 13485 as a Quality Management System for Medical Devices - webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 12-16-2010 Last Day: 12-16-2010
Overview: This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements. ISO 13485:2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards. Medical device firms certified to ISO 13485:2003 will find themselves very closely compliant with FDA's Quality System Requirements under 21CFR 820. Areas Covered in the Session: * Principles of ISO 13485:2003 * ISO 9001 & ISO 13485 Differences * Design Control…
Teens Using Drugs: What To Know and What To Do

Teens Using Drugs: What To Know and What To Do

Location: , United States
Category: Health and Medicine
Start Date: 01-04-2011 Last Day: 01-04-2011
"Teens Using Drugs: What To Know and What To Do" is a FREE, ongoing, two-part workshop series designed to help participants learn to understand, identify and address adolescent alcohol/other drug problems. Part 1 is presented on the first Tuesday of each month from October through June, provides information on how to understand and recognize the signs of a teen substance abuse problem, and includes a short video. Part 2 is presented on the second Tuesday of each month from October through June, provides information on what should and should not be done when a teen substance abuse problem is recognized,…
OSHA – 10 Major Differences between Federal OSHA and California OSHA Compliance and Enforcement

OSHA – 10 Major Differences between Federal OSHA and California OSHA Compliance and Enforcement

Location: , United States
Category: Health and Medicine
Start Date: 01-06-2011
Learn 10 major difference between Cal/OSHA and Federal OSHA and how to respond to it in case of OSHA inspection. This webinar covers the whys, how’s, and appropriate response to differences between federal and other state OSHA programs and California OSHA (Cal/OSHA). Corporations with employees in California should participate in this webinar to receive a concise and expertly-prepared presentation of the differences between federal OSHA and Cal/OSHA. Discussion will be done on the OSHA program: standards, enforcement procedures, penalties, and the appeals process.
What are the Scientific Basis of Clinical Research and the hall mark of a good study protocol?

What are the Scientific Basis of Clinical Research and the hall mark of a good study protocol?

Location: , United States
Category: Health and Medicine
Start Date: 01-07-2011
Learn the scientific standards of drug development process, the regulations to follow in Phase I and how to manage each phase of drug development process. This Webinar goes over the scientific standards of the drug development process. Starting with the drug discovery process, the role of the dose response relationship, the role of the IND process is discussed. You will learn the regulations to follow in Phase I and the 6 major questions that must be answered in this Phase. The determination of the first dose in humans is another critical point in the process. Learn the questions each Phase…
An Easy to Implement Integrated Risk Management Approach Compliant with ISO 14971 - Medical Device Webinar By ComplianceOnline

An Easy to Implement Integrated Risk Management Approach Compliant with ISO 14971 - Medical Device Webinar By ComplianceOnline

Location: , United States
Category: Health and Medicine
Start Date: 01-10-2011 Last Day: 01-10-2011
This Integrated Risk Management Approach training in ISO 14971 will discuss how to incorporate risk management as per ISO 14971 in all phases of medical device development and what all documentation to be gathered to support the decisions made as a part of risk management process. This webinar will cover all major elements of ISO 14971 and present a methodology for integrating the requirements of this standard into the product development process to ensure that the requirements of the standard are met, and the medical device is designed to be safe and effective. The webinar will specify how risk management…
The Process Approach to Auditing - Webinar By GlobalCompliancePanel

The Process Approach to Auditing - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 01-11-2011 Last Day: 01-11-2011
Overview: The structure of ISO 9001:2000 provides a focus on the processes that comprise the quality management system (QMS). Also, the general requirements laid out in Clause 4.1, the foundation for auditing a process-based system, are taken up for discussion at this webinar. There are eight basic processes that an organization must have to function effectively. These are: * Management of the Quality System * Top management involvement * Customer focus * The improvement process * Design and development * Supplier management * Product provision (including control of outsourced processes), and * Resource management. Their nature and effectiveness are discussed…
A Comparison of ICH Q-10 Quality System and the FDA's Quality Systems Approach (QSA) to the Pharmaceutical GMPs - Webinar By GlobalCompliancePanel

A Comparison of ICH Q-10 Quality System and the FDA's Quality Systems Approach (QSA) to the Pharmaceutical GMPs - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 01-11-2011 Last Day: 01-11-2011
Overview: In September of 2006, the FDA published the Quality System Approach to Pharmaceutical Good Manufacturing Practices which provided a quality orientation to the GMP's Then in June of 2008, The International Conference on Harmonization (ICH) published ICH-Q10, Pharmaceutical Quality System. These guidance documents have provoked thought and raised questions about existing pharmaceutical. During this webinar, the present status of these Guidances will be discussed and suggestions for their implementation will be presented. This webinar will be very informative for Quality Assurance personnel who have the desire to move toward implementing quality concepts rather than focusing on the strict rules…
Navigating Pediatric Trials from recruitment to successful on-time completion - Webinar By GlobalCompliancePanel

Navigating Pediatric Trials from recruitment to successful on-time completion - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 01-12-2011 Last Day: 01-12-2011
Overview: Drug companies face many challenges in pediatric clinical research. Pediatric trials come with a high level of complexity and cost. In order for professionals to carry out a successful pediatric drug development plan, they need the right infrastructure and information to avoid obstacles such as slow recruitment, noncompliance and difficulties in developing the right study criteria and protocol. When conducting research on children, drug companies must ensure that ethical boundaries are observed in both the design and execution of pediatric trials. Attend this Webinar to understand the ethical, economic, regulatory and technical considerations when conducting clinical studies on children.…
101 cGMP To-Do List for 2011 - Webinar By GlobalCompliancePanel

101 cGMP To-Do List for 2011 - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 01-12-2011 Last Day: 01-12-2011
Overview: This webinar will examine the broad range of issues a company's senior management and QA/RA need to consider in their annual Management Review of their existing quality management system. Such a review takes on added urgency as a result of the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what it (the FDA and industry) need to do internally. A review of recent information from the Agency, other goals of the Agency that have already been translated into action in the past year will provide direction in areas…
FDA 483 Observations in the Laboratory. What went wrong? How can they be avoided? - Webinar By GlobalCompliancePanel

FDA 483 Observations in the Laboratory. What went wrong? How can they be avoided? - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 01-12-2011 Last Day: 01-12-2011
Overview: In order to proactively address areas of concern to the FDA and other regulators, All units within each pharmaceutical firm should review recent regulatory observations and proactively establish programs or systems to address the regulatory concerns. In this webinar we will focus on the laboratory and recent FDA laboratory based operations. We will review observations, identify the real issue and suggest actions to prevent similar observations in other laboratories. Why you should attend: An FDA 483 observation can have an impact on any unit within a firm and laboratories have received more than their share. Since the early 1990s,…

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