World Conference Calendar

33818 Conferences

Health and Medicinerss


Why Medical Device Companies Receive Warning Letters - Webinar by GlobalCompliancePanel

Why Medical Device Companies Receive Warning Letters - Webinar by GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 09-21-2010 Last Day: 09-21-2010
The Commissioner of the US FDA has stated the agency will be more enforcement oriented and quicker to issue Warning Letters. This presentation will review current enforcement practices of the US FDA with actual Warning Letters recently issued to medical device companies. We will explore how the company failed to meet FDA expectations in response to inspection and other violations. In the presentation we will attempt to determine what response by the manufacturer may have prevented the issuance of the Warning Letter. We will look at improvements to the Quality System as well as responses to the FDA-483 that was…
Quality by Design (QbD) and Analytical Methods - Webinar by GlobalCompliancePanel

Quality by Design (QbD) and Analytical Methods - Webinar by GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 09-21-2010 Last Day: 09-21-2010
As the industry is moving towards applying Quality by Design (QbD) to process development, the question must be asked: Is this also the way forward to revolutionise, improve and standardise our approach to method development and qualification? The pharmaceutical industry has traditionally controlled analytical methods via a well defined sequence of development, validation and transfer exercises in line with agreed standards such as the quality guidelines ICH Q2. Such an approach limits the scope for technological innovation or improvements in quality or efficiency of methods for established products. Applying QbD would enable enhanced method understanding, and a more systematic and…
Auditing Computer System Validation Materials - Webinar by GlobalCompliancePanel

Auditing Computer System Validation Materials - Webinar by GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 09-21-2010 Last Day: 09-21-2010
This presentation will provide auditors who are not knowledgeable about computer system validation with a basic understanding of the requirements and expectations for validation documentation. We will address the basic components of computer system validation, the importance of assessing the quality of such validations performed by vendors, suggested procedures for reviewing validation documentation to ensure a meaningful review in a limited period of time, and how to establish reasonable remedial actions in the case of inadequate validation documentation. Auditing CSV materials is an important element in most audits of CROs, technical service providers (TSPs), and application hosting organizations. Attendees should…
Managing the IDE (Investigational Device Exemption) Submission for Compliance Success - Webinar by GlobalCompliancePanel

Managing the IDE (Investigational Device Exemption) Submission for Compliance Success - Webinar by GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 09-21-2010 Last Day: 09-21-2010
An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to FDA. Clinical studies are most often conducted to support a PMA. Only a small percentage of 510(k)'s require clinical data to support the application. Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated. An approved…
EU IMPD vs. US IND: Comparing the Content and Agency Expectations

EU IMPD vs. US IND: Comparing the Content and Agency Expectations

Location: , United States
Category: Health and Medicine
Start Date: 09-21-2010 Last Day: 09-21-2010
This training on EU IMPD & US IND will help you in understanding the clinical trial and registration / licensing differences between US and EU as per EU IMPD and US IND and cover the guidance document explaining data expectations in Phase I, II, III and licensing. Why Should You Attend: This course specifically focuses on the nuances and real differences between two ICH areas of the World: the U.S. and the EU. We will cover every aspect of running clinical studies, including what can be harmonized and used elsewhere globally and talk about the implications of receiving Scientific Advice,…
The Cosmetic-Cosmeceutical Distinction: Walking the Line in Developing Label Claims - Webinar by GlobalCompliancePanel

The Cosmetic-Cosmeceutical Distinction: Walking the Line in Developing Label Claims - Webinar by GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 09-22-2010 Last Day: 09-22-2010
Drafting claims where you "walk the line" between cosmetic and drug claims is an art with little existing practical guidance. Although different experts can disagree about a particular claim, the labeling regulations are based on a strong regulatory foundation. After a discussion of pertinent U.S. laws and regulations, we extensively examine actual claims and determine whether they cross the line We will each examine claims to better understand the cosmetic/cosmeceutical interface. It will be fast paced but fun! Then, you will have a chance to ask questions about the presentation and related issues. By the end of the presentation, you…
Compiling the Design History File, and Technical File / Design Dossier - Webinar by GlobalCompliancePanel

Compiling the Design History File, and Technical File / Design Dossier - Webinar by GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 09-22-2010 Last Day: 09-22-2010
This webinar will examine both the FDA and MDD regulatory expectations for the respective DHF and TF / DD. It will discuss the major sections of both, common elements and differences, what must be included and what should be included, and how the information should be compiled and presented. Major modules of a DHF SOP and a TF / DD SOP will be presented and discussed -- the webinar will address the development of a new, or revision of an existing DHF SOP and TF / DD to ensure they meet regulatory expectations and assist those charged with compiling, updating…
Preparing for FDA Inspections in a Changing Regulatory Environment - Webinar by GlobalCompliancePanel

Preparing for FDA Inspections in a Changing Regulatory Environment - Webinar by GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 09-22-2010 Last Day: 09-22-2010
Ready for Inspection by Hamburg's FDA? Under Commissioner Hamburg's new enforcement policy, FDA has issued more warning letters more quickly than it has in years. In some cases, the agency has even skipped warnings and gone straight from inspectional observations to injunctions and seizures. Clearly, the stakes will be higher at your next inspection. The question is: What steps should you take now to be ready for it? The key to effective management of regulatory inspections is effective preparation. Being well organized and confident during the inspection means that your firm gives it's best possible performance which in turn gives…
Effective Quality Process Improvement for Medical Device Firms: Donít get caught managing process through standardized SOPís

Effective Quality Process Improvement for Medical Device Firms: Donít get caught managing process through standardized SOPís

Location: , United States
Category: Health and Medicine
Start Date: 09-23-2010 Last Day: 09-23-2010
This webinar will change your ďSOP mindsetĒ. It will review the principles and skills needed which will help to assure your SOPís are the result of well defined, sound processes that are exactly what you want, and need, to run your medical device business; stripped of the fat while assuring compliance. Areas Covered in the Seminar: - Understanding Lean Compliance principles. - Avoiding living in pain. - Rules that apply in order to utilize a Lean Compliance approach. - Advantages of utilizing Lean Compliance. - SOP-based mindset vs. a Process-first approach. - Steps in the Lean Compliance process. - Walkthrough…
14th Congress of the European Federation of Neurological Societies (EFNS 2010)

14th Congress of the European Federation of Neurological Societies (EFNS 2010)

Location: , Switzerland
Category: Health and Medicine
Start Date: 09-25-2010 Last Day: 09-28-2010 Deadline for abstracts: 03-25-2010
The 14th Congress of the European Federation of Neurological Societies (EFNS) provides an unmatched opportunity for participants to join over 4,500 colleagues to study and disseminate the latest research. Discover current clinical practices and treatments, and be an integral part of the central network of neurology in Europe. Call for Abstracts Participants are requested to submit an abstract to the Secretariat no later than March 25, 2010 together with the registration form and fees. The Congress Programme Committee welcomes the submission of abstracts on any neurological topic. The committee will decide the form of presentation: oral or poster. If you…
How to Use Foreign Trial Data in Your NDA Approval Process

How to Use Foreign Trial Data in Your NDA Approval Process

Location: , United States
Category: Health and Medicine
Start Date: 09-28-2010 Last Day: 09-28-2010
In this NDA Approval Process training Webinar learn the guidance and regulations governing FDAís acceptance of foreign trial data and know how FDA implementing these rule along with design considerations and requirements for foreign trials. Areas Covered in the Seminar: - Guidances and regulations that govern the FDAís acceptance of foreign trial data as pivotal data for NDA approval. What you can do to ensure compliance. - Design considerations and requirements for foreign trials. - Identify which guidances and regulations govern the FDAís acceptance of foreign trial data as pivotal data for NDA approval;. - Discuss how FDA is implementing…
Validating Radiation Sterilization for medical device industries

Validating Radiation Sterilization for medical device industries

Location: , United States
Category: Health and Medicine
Start Date: 09-28-2010 Last Day: 09-28-2010
This Radiation sterilization training will discuss how radiation sterilization works, the equipment involved, major issues with product sterilization via radiation, and the validation requirements. Routine process control and monitoring will be reviewed along with requirements to maintain the process effectiveness. Areas Covered in the Seminar: - Introduction. - Terminology / Definitions. - Radiation characterization / effectiveness. - Process Equipment. - Product and Material Issues. - Process Definition. - Validation IQ/OQ/PQ. - Documentation, review and approval of validation. - Routine Monitoring. - Product Release. - Maintenance of process effectiveness. For More Details: http://bit.ly/cGzp28
Robust Process Validation for Medical Devices - Webinar by GlobalCompliancePanel

Robust Process Validation for Medical Devices - Webinar by GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 09-28-2010 Last Day: 09-28-2010
One of the most common reasons noted by the FDA for recalls of medical device is improper validation. It is also one of the most common reasons companies receive 483s and warning letters. Conversely, successful validations not only satisfy compliance and regulatory requirements, they also provide for robust manufacturing processes satisfying the needs of many individual functions within your organization How do we get there? After we have a clear understanding of the regulatory intent of validation, the key for a robust process validation is the use of six sigma techniques and risk management. The rigor of a validation should…
Preparing for and Surviving an FDA Inspection - Webinar by GlobalCompliancePanel

Preparing for and Surviving an FDA Inspection - Webinar by GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 09-28-2010 Last Day: 09-28-2010
The purpose of the FDA inspection is a verification activity that should demonstrate to the regulatory agency and provide assurance that products consistently meet quality expectations and that your company is operating in a consistent and compliant state of control. The key to a successful audit is being able to communicate how your quality systems assure this state of control. However, the arrival of an investigator for an inspection can still be an intimidating experience. The inspection can be less traumatic if the site and its personnel are properly prepared for the inspection and the investigator. During this hour presentation,…
The FDA Tripod - Clinical Trial Regulations, Compliance and GCP in Drug Development - Webinar by GlobalCompliancePanel

The FDA Tripod - Clinical Trial Regulations, Compliance and GCP in Drug Development - Webinar by GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 09-29-2010 Last Day: 09-29-2010
This course provides a comprehensive review of Good Clinical Practice (GCP) and FDA regulations and requirements. Participants receive a foundation of knowledge about GCP, practical examples, and the underlying scientific and regulatory principles involved. Guidelines for each aspect of research are provided, as well as information on the structuring and preparation of protocols, consent forms, and investigator brochure. Information on maintaining ongoing compliance will also be discussed. This course enables clinical professionals to prepare concise documents and provide their company and the FDA with necessary information for their clinical studies. Areas Covered in the Session: * Discuss the FDA's role…
Managing Product Medical Device Recall Efficiently and Effectively - Webinar by GlobalCompliancePanel

Managing Product Medical Device Recall Efficiently and Effectively - Webinar by GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 09-30-2010 Last Day: 09-30-2010
Recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death. It is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. A medical device recall does not always mean that you must stop using the product or return it to the company. A recall sometimes…
How to Survive a DEA Audit or FIND=FINE - Webinar by GlobalCompliancePanel

How to Survive a DEA Audit or FIND=FINE - Webinar by GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 09-30-2010 Last Day: 09-30-2010
This training entitled "How to Survive a DEA Audi or FIND=FINE" will cover all the record-keeping and security requirements that a DEA registered pharmacy must comply with when handling controlled substances and regulated chemicals. It covers all elements of what occurs during an unannounced DEA Diversion inspection and the auditing of all controlled substances and regulated chemicals. Why should you attend: When DEA Diversion personnel conducts an unannounced inspection of a pharmacy to perform an audit, they generally do not inform the DEA registrant on what steps will be taken during the inspection. In some cases, the pharmacist is not…
5th International CECD Conference

5th International CECD Conference

Location: , Canada
Category: Health and Medicine
Start Date: 10-01-2010 Last Day: 10-02-2010
Provide a forum where academics and practitioners met to share recent findings and practical experiences and collaborate on innovative approaches. Promote dementia care that supports the philosophical approach of personhood. Organized by: The Society for the Arts in Dementia Care INVITATION (From 2009 Conference) On behalf of the Conference hosts, Aged and Community Services SA & NT Inc. and the Society for the Arts in Dementia Care (Australia) Inc. I am pleased to invite you to attend the 4th International Conference on Creative Expression, Communication and Dementia. There is growing evidence that demonstrates that creative arts programs provide many therapeutic…
INTRINSICALLY DISORDERED PROTEINS IN BIOMEDICINE

INTRINSICALLY DISORDERED PROTEINS IN BIOMEDICINE

Location: , Spain
Category: Health and Medicine
Start Date: 10-04-2010 Last Day: 10-06-2010 Deadline for abstracts: 07-15-2010
Intrinsically disordered proteins are Natureís response to the increased complexity of higher organisms and are associated with diseases such as Cancer and Neurodegeneration. Genome sequencing projects and bioinformatics analyses have shown that disordered proteins are highly abundant in eukaryotes and are tightly regulated. Enabling technologies that offer structural information in solution, such as Nuclear Magnetic Resonance, Small Angle X-ray scattering, and single molecule fluorescence, are providing novel insights into the structural propensities and interactions of disordered proteins. A new paradigm, in which dynamic averaging of conformational ensembles is central, is emerging for the structural and functional analysis of disordered proteins.…
The FDA Tripod - Clinical Trial Regulations, Compliance and GCP in Drug Development

The FDA Tripod - Clinical Trial Regulations, Compliance and GCP in Drug Development

Location: , United States
Category: Health and Medicine
Start Date: 10-05-2010 Last Day: 10-05-2010
This GCP training Webinar will discuss the principals of GCP, the regulations pertaining to it and elements necessary for FDA compliance. Areas Covered in the Seminar: - Discuss the FDAís role in Drug Development. - Principles of GCP. - Activities that are common to most trials. - Summarize FDA GCP regulations. - Recognize how GCP impacts the clinical research process. - Prepare concise documents and provide. - Necessary information for clinical studies compliance. - Maintain ongoing compliance. For More Details: http://bit.ly/9k8s9w

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