World Conference Calendar

32801 Conferences

Physical and Life Sciencesrss


Understanding Design Controls for Medical Devices

Understanding Design Controls for Medical Devices

Location: , United States
Category: Physical and Life Sciences
Start Date: 02-23-2012 Last Day: 02-23-2012
This webinar will cover the basics of design controls for medical devices, and provide recommendations for implementation of a compliant design control system. Also discussed will be design control requirements for devices already in distribution. Documentation requirements for each design stage will be included as well. Why You Should Attend: Prior to introduction of a new device, or even a modified design for an existing device, a systematic process must be followed. This process must ensure that all requirements are met. A firm's design control process must meet all regulatory requirements, but at the same time not be as unwieldy…
OSHA Recordkeeping: Recent Recordkeeping Interpretations

OSHA Recordkeeping: Recent Recordkeeping Interpretations

Location: , United States
Category: Physical and Life Sciences
Start Date: 02-27-2012 Last Day: 02-27-2012
This 90-minute OSHA Recordkeeping training class will incorporate the lessons learned from OSHA’s recent Interpretation Letters into the existing OSHA recordkeeping analysis as well as OSHA’s current Frequently Asked Questions. In this interactive program, OSHA recordkeeping scenarios will be used so that the rules articulated in the recent Interpretation Letters can be applied to real-life factual situations that arise in your work environments. Why Should You Attend: OSHA injury and illness recordkeeping compliance is a point of emphasis for OSHA, and the recordkeeping regulations are frequently cited by the Agency. In addition to providing instruction on how to apply the…
4th Annual AsiaTides - Oligonucleotide & Peptide

4th Annual AsiaTides - Oligonucleotide & Peptide

Location: , Japan
Category: Physical and Life Sciences
Start Date: 02-28-2012 Last Day: 03-01-2012
The best forum to gain applied and basic knowledge, build your collaborative network, and learn skills to move your projects forward in one of today's hottest research areas AsiaTIDES continues to be the premier forum to get a comprehensive update, meet key players and increase your knowledge of the oligonucleotide- and peptide-based therapeutics fields. The faculty list for the 2012 program is the strongest yet, with more representation from big pharma than ever before. Hear new data and strategic perspectives from Merck, Genzyme, and GlaxoSmithKline, including three presentations from Glaxo on a peptide project and their assessments of both the…
Regulatory Perspectives of Clinical Project Management: Meeting FDA Requirements for Clinical Trials

Regulatory Perspectives of Clinical Project Management: Meeting FDA Requirements for Clinical Trials

Location: , United States
Category: Physical and Life Sciences
Start Date: 02-28-2012 Last Day: 02-28-2012
This 90-minute webinar will provide an overview of regulatory management for clinical trials. It will discuss key regulatory aspects of a clinical project such as clinical protocol management, IRB management, safety reporting, rules for recruitment programs, seeking advice from FDA, trial master files, and training requirements. Why Should You Attend: Clinical Project Managers need to have clear perspective of what may be needed for assuring compliance with FDA requirements of a given clinical trial at all times. Non-compliance with these requirements could lead to rejection of the trial data, and even other more severe penalties. This course will provide an…
Solutions to the Challenges of Phase I and FIM Studies in Today’s World

Solutions to the Challenges of Phase I and FIM Studies in Today’s World

Location: , United States
Category: Physical and Life Sciences
Start Date: 02-29-2012 Last Day: 02-29-2012
This 90-minute webinar will help you identify the challenges in Phase I and FIM studies and present solutions on how to overcome these challenges. Why Should You Attend: As need for more aggressive drug development that still ensures the safety of the subjects and the drug itself becomes more and more important, the challenges of those individuals responsible for the Phase I activities increase exponentially. To not meet these challenges has consequences. The lines of distinction between the classical phases in the drug development are becoming more and more blurred, and the challenges facing the Sponsor, the Principal Investigator, and…
Predicting Warranty Expense Using Reliability Analysis Methods

Predicting Warranty Expense Using Reliability Analysis Methods

Location: , United States
Category: Physical and Life Sciences
Start Date: 03-05-2012 Last Day: 03-05-2012
This webinar will show how you can use failure data to predict expected future failures, proactively drive quality and reliability improvement and react quickly to emerging issues. Why Should You Attend: Manufacturers design and develop products based on an expected product lifetime. Many manufacturers conduct extensive reliability testing to minimize the risk that products will fail prematurely. Despite these efforts, unexpected failures occur due to design flaws, manufacturing process changes, or a misunderstanding of the product use environment. Premature failures alienate customers and significantly impair brand and company reputations. Failure data may be easily modeled to forecast future failures and…
Audit/Inspection Preparedness for Clinical Research/Site Coordinators

Audit/Inspection Preparedness for Clinical Research/Site Coordinators

Location: , United States
Category: Physical and Life Sciences
Start Date: 03-06-2012 Last Day: 03-06-2012
This webinar on clinical site audit/ inspection will outline the responsibilities of the Investigator and the clinical research coordinator during and after site audits/inspections and show what you must do to ensure preparedness at all times. Why Should You Attend: The Clinical Research Coordinator (CRC) plays a key role in the site’s success at audits/inspections, and must therefore know how to ensure the site is ready for an audit or inspection at all times. In order to ensure audit/inspection preparedness, the CRC must be aware of the applicable regulatory and sponsor requirements, guidelines and SOPs, and ensure the conduct of…
Medical Device Adverse Event Reporting and Vigilance System During Clinical Trials and Post-Marketing: US, EU, and Canada

Medical Device Adverse Event Reporting and Vigilance System During Clinical Trials and Post-Marketing: US, EU, and Canada

Location: , United States
Category: Physical and Life Sciences
Start Date: 03-06-2012 Last Day: 03-06-2012
This 3-hr virtual seminar will discuss the requirements and compliance in medical device adverse event reporting and medical device surveillance/vigilance system in the US, Europe and Canada. It is designed to help the audience with their global compliance in adverse event reporting and surveillance/vigilance system during pre- and post-marketing. Why Should You Attend: To be able to achieve sustainability and to remain sustainable and competitive in global medical device markets, it is necessary to streamline regulatory compliance processes, in particular, the Adverse Event (AE) Reporting during clinical studies and post-marketing. Thus, to establish and maintain a medical device AE reporting…
When Do You Need a 510K? - Webinar By ComplianceOnline

When Do You Need a 510K? - Webinar By ComplianceOnline

Location: , United States
Category: Physical and Life Sciences
Start Date: 03-07-2012 Last Day: 03-07-2012
This 90-minute webinar will help you understand the 510K process including some history about 510ks versus PMAs and give you the necessary information to know when to file a 510k, as opposed to a PMA, or to not file any 510K of a new or existing medical device. Why Should You Attend: FDA is responsible for overseeing entry into the market of all medical devices. All devices, unless exempt, must go through a pre-market review for safety and efficacy. Anyone who wants to be a player in the medical device market must have a sound understanding of what is expected…
Method Validation in Drug Development Process - Common Mistakes and Issues

Method Validation in Drug Development Process - Common Mistakes and Issues

Location: , United States
Category: Physical and Life Sciences
Start Date: 03-07-2012 Last Day: 03-07-2012
This Method Validation training in drug development process will provide guidance in setting appropriate specifications, determining if the assay is validatable, and monitoring progress during the validation. Why Should You Attend: This webinar will address frequently observed issues and problems with method validations. Validated methods are required for Phase III of the drug development process. Moving methods from the development phase to the validated phase ready for sample analysis does not always occur without unforeseen issues arising. Differences in laboratories and analysts, as well as instrumentation can contribute to delays in validating methods. Setting appropriate specifications and criteria based on…
Managing Immunogenicity Risk in Biopharmaceuticals

Managing Immunogenicity Risk in Biopharmaceuticals

Location: , United States
Category: Physical and Life Sciences
Start Date: 03-08-2012 Last Day: 03-08-2012
Why Should You Attend: This presentation begins with an overview of the biological self versus non-self mechanism resulting in the anti-drug response of biopharmaceuticals. The next section describes how to differentiate the risk associated with internal attributes of the drug from the risk derived from external factors. That guideline in conjunction with the latest industry recommendations and regulatory guidelines provides a logical approach to the risk strategy. The second-half of the presentation demonstrates how to use pre-clinical results to further characterize (but not predict) the immunogenicity response and utilize this information to be ready for adverse effects during clinical trials.…
Application of CAPA to the Device Sterilization Process

Application of CAPA to the Device Sterilization Process

Location: , United States
Category: Physical and Life Sciences
Start Date: 03-14-2012 Last Day: 03-15-2012
Course Description: Do you use a Contract Sterilizer for your medical device sterilization? Are you not an expert in industrial sterilization? If you answered “yes” to either of these questions, this seminar is a must for you and your team members. The FDA and your Notified Body will look to you, the medical device manufacturer, for the answers to deficiencies in the sterilization process whether sterilization is performed at your location or at a contract sterilizer. In this seminar you will be provided a basic understanding of radiation and EO sterilization processes and validation methods associated with both methods. Typical…
Disinfectant Validation and Cleanroom Cleaning for all FDA and EMEA regulated companies - Pharmaceutical Webinar By ComplianceOnline

Disinfectant Validation and Cleanroom Cleaning for all FDA and EMEA regulated companies - Pharmaceutical Webinar By ComplianceOnline

Location: , United States
Category: Physical and Life Sciences
Start Date: 03-16-2012 Last Day: 03-16-2012
This Disinfection and Cleanroom Cleaning training will teach you how to choose the best disinfectants, know the different performance parameters of disinfectants, methods to qualify disinfectants, writing and executing cleaning procedures. Areas Covered in the Seminar: * Disinfectants commonly used in the industry, their modes of action, efficacy, and toxicity. * Understanding the nature of contaminants in the cleanroom and which disinfectants will be effective against them. * Benefits and drawbacks for using each type of disinfectant used in the Pharmaceutical Industry. * Bodies that regulate disinfectant manufacturers and testing required by manufacturer’s for label claim. * Learn disinfectant testing…
OSHA Inspections – Avoiding the 10 Most Common Mistakes

OSHA Inspections – Avoiding the 10 Most Common Mistakes

Location: , United States
Category: Physical and Life Sciences
Start Date: 03-19-2012 Last Day: 03-19-2012
This OSHA inspection webinar will cover aspects of an OSHA inspection from how establishments are targeted, how to limit the scope of an inspection or investigation, how not to self-incriminate, and when and how to appeal. Why Should You Attend: An OSHA inspection can be a costly and disruptive experience for any employer, especially if that employer has not dealt with the Agency, does not have an in-house safety professional or attorney. An OSHA inspection that goes badly essentially says the employer has a defective safety program, is not sufficiently focused on the safety and health of its employees, or…
Elegant Quality Assurance Practices for Device Efficacy and Efficiency Requirements

Elegant Quality Assurance Practices for Device Efficacy and Efficiency Requirements

Location: , United States
Category: Physical and Life Sciences
Start Date: 03-23-2012 Last Day: 03-23-2012
This 90-minute webinar on medical device quality assurance practices will review robust quality assurance principles and teach you techniques and lean methods to help you implement FDA Quality System Requirements. Why Should You Attend: Quality assurance work force is considered as the bearer of bad news. It should be the bearers of good news. They can anticipate adverse events and near misses before they happen and prevent them from happening. This seminar emphasizes elegant solutions to quality improvements resulting in high return on investment. This is one of the good news management is looking forward to. Then your organization can…
Transferring a Medical OEM Molding and Assembly Operation to a Manufacturer With Validated Systems and Processes

Transferring a Medical OEM Molding and Assembly Operation to a Manufacturer With Validated Systems and Processes

Location: , United States
Category: Physical and Life Sciences
Start Date: 03-29-2012 Last Day: 03-30-2012
Course Description: Learn from successful case studies on how to Transfer a Medical OEM Molding Operation to a world class molder and Transferring an Assembly Operation from one OEM supplier to another manufacturer with Validated Systems and Processes. This 2-day seminar will provide valuable assistance and give a process and procedure to all regulated companies that are transferring equipment, molds, dies, systems and processes to suppliers. It will show how quality, verifications and validations process will meet today’s standards for the FDA and CE Mark. This interactive workshop will guide you in the procedures and process of transferring equipment, tools…
Foreign Manufacturing Facilities – Avoiding Problems with FDA

Foreign Manufacturing Facilities – Avoiding Problems with FDA

Location: , United States
Category: Physical and Life Sciences
Start Date: 03-29-2012 Last Day: 03-29-2012
This 90-minute webinar on compliant foreign manufacturing facilities will help you understand the problems that can occur with foreign manufacturers of pharmaceuticals. Recent inspections and enforcement actions by FDA have brought the topic into greater focus. Why Should You Attend: The FDA regulates foreign manufacturers of pharmaceuticals to be imported into the United States. Remote monitoring of quality assurance parameters can present challenges for foreign manufacturers in Central and South American and Asia. Failure to comply with FDA standards can lead to extremely large fines, enhanced scrutiny, and rigid monitoring. Proper determination of stability characteristics and expiration dates must be…
Full-day Virtual Seminar - Quality Agreements with Pharmaceutical/ Biologic Manufacturers and the Use of Drug Master Files

Full-day Virtual Seminar - Quality Agreements with Pharmaceutical/ Biologic Manufacturers and the Use of Drug Master Files

Location: , United States
Category: Physical and Life Sciences
Start Date: 03-30-2012 Last Day: 03-30-2012
Why Should You Attend: This course provides attendees with an understanding of the role that Quality Agreements and DMFs play in the FDA's regulatory approval process for drugs and biologics. The course will take participants through a step-by-step process of when Quality Agreements are appropriate, how they should be prepared, formatting, content and negotiations around the agreement. The DMF section will explain preparation and explain the types of information essential for any Drug Master File. Additionally, this course explains why "one size does not fit all" and emphasizes the importance of customizing DMFs in both preparation and maintenance for particular…
CFR 21 Part 11 and Annex 11: How to Avoid the Audit Traps

CFR 21 Part 11 and Annex 11: How to Avoid the Audit Traps

Location: , United States
Category: Physical and Life Sciences
Start Date: 04-04-2012 Last Day: 04-04-2012
This 90-minute webinar on Part 11/Annex 11 audit and enforcement will tell you what the auditors are trained to look for during a Part 11/Annex 11 “tag along” audit. It will cover inspection trends with examples of some recent 483s and warning letters and show what you need to do to have a successful inspection outcome. Description Regulatory compliance requirements for CFR 21 Part 11/Annex 11 (also known as ERES) have undergone several revisions since its inception during the late 1990s. While the agencies have endeared themselves to the industry by adopting a flexible audit approach for ERES, they are…
QbD Approach to Analytical Method Lifecycle: Design, Development, Validation, Transfer

QbD Approach to Analytical Method Lifecycle: Design, Development, Validation, Transfer

Location: , United States
Category: Physical and Life Sciences
Start Date: 04-04-2012 Last Day: 04-04-2012
This 120-minute webinar on using the QbD Approach to Analytical Method Lifecycle is designed to provide participants with a lifecycle approach to developing and validating analytical methods and comply with compendial requirements. Description This webinar is designed to provide participants with a lifecycle approach to developing and validating analytical methods. By using a lifecycle approach, methods are more likely to meet their intended purpose, and scientists are more likely to have success during validation and transfer exercises. The course will build on traditional concepts of method development, validation and transfer by introducing the Analytical Target Profile (which identifies what the…

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