World Conference Calendar

31708 Conferences

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Combination Products: FDA's Proposed Rule for GMP Requirements and Introduction and Expectations for "Combo" Products - Webinar by GlobalCompliancePanel

Combination Products: FDA's Proposed Rule for GMP Requirements and Introduction and Expectations for "Combo" Products - Webinar by GlobalCompliancePanel

Location: , United States
Category: Business and Economics
Start Date: 10-14-2010 Last Day: 10-14-2010
What is a combination product? What are some examples of combination products? How are combination products assigned for review? Where can I find guidance for how master files can be used in the submission of information relevant to my combination product Determine which Center will review my combination or non-combination product? These topics and more will be addressed during this Webinar, including recently FDA's proposed rule to codify the current good manufacturing practice (cGMP) requirements applicable to combination products. This proposed rule is intended to promote the public health by clarifying which cGMP requirements apply when drugs, devices, and biological…
Master Verification and Validation Planning to Meet US FDA, ISO 13485 and 14971:2009 Requirements - Webinar by GlobalCompliancePanel

Master Verification and Validation Planning to Meet US FDA, ISO 13485 and 14971:2009 Requirements - Webinar by GlobalCompliancePanel

Location: , United States
Category: Business and Economics
Start Date: 10-19-2010 Last Day: 10-19-2010
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols. How to employ equipment / process DQs, IQs, OQs, and PQs, against a background of limited company resources (personnel, budget, time). A matrix simplifies "as-product", "in-product", process, and equipment, et al, software V&VT, assuring key FDA requirements are not overlooked. The QMS and 21 CFR…
The ICF Process: Tips on Achieving Optimal compliance and Comprehension - Webinar by GlobalCompliancePanel

The ICF Process: Tips on Achieving Optimal compliance and Comprehension - Webinar by GlobalCompliancePanel

Location: , United States
Category: Business and Economics
Start Date: 10-20-2010 Last Day: 10-20-2010
The ICF process, which involves communication between a consentee (patient/subject) and a consenter (staff clinician/designee), is a vital component to the authorization of any medical intervention or clinical research trial. IRBs, sponsors and clinical sites all share the responsibility of ensuring an adequate ICF process. Any inadequate ICF training to clinical sites and /or unclear communication regarding the ICF content to potential subjects can result in detrimental consequences to the process that can ultimately affect data integrity and patient safety and/or well-being. This session will discuss the issues and consequences surrounding an inadequate informed consent process and provide tips on…
Fundamentals of FDA

Fundamentals of FDA

Location: , United States
Category: Business and Economics
Start Date: 10-20-2010 Last Day: 10-20-2010
This webinar will provide help both sponsor companies (pharmaceutical, biotech, device/diagnostics), and clinical sites utilize quality improvement methods and effectively prepare for upcoming GCP inspections. Why should you attend: Oftentimes, GCP inspections, particularly from FDA investigators, can be seen as an intimidating and adversarial experience as opposed to a process used to improve quality and ensure compliance. Overall, inspections are an important part of the GCP process that helps prove that the final study product is safe and effective for consumer use. This webinar will provide help both sponsor companies (pharmaceutical, biotech, device/diagnostics) and clinical sites utilize quality improvement methods…
Microbiological Foodborne Threat  - Webinar by GlobalCompliancePanel

Microbiological Foodborne Threat - Webinar by GlobalCompliancePanel

Location: , United States
Category: Business and Economics
Start Date: 10-20-2010 Last Day: 10-20-2010
As your company's system continues to grow, the potential for "crisis issues" to occur grows proportionally. The concern for food safety to your customers and employees must be a constant area of focus for all operators in the system. Ultimately, how well your company manages the crisis situations it will make a significant difference in how your company brand is perceived in the public's eyes and how well it succeeds in today's highly competitive marketplace. Most important is that failure to ensure food safety can jeopardize the health of your customers and could be detrimental to your business and reputation.…
Supplier Evaluation and Assessment: How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner - Webinar by GlobalCompliancePanel

Supplier Evaluation and Assessment: How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner - Webinar by GlobalCompliancePanel

Location: , United States
Category: Business and Economics
Start Date: 10-21-2010 Last Day: 10-21-2010
Supplier qualification and assessment is required in both the QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance with this. Many companies can spend MUCH LESS time and money, and still be in control of their suppliers and in compliance with the regulations. This presentation will review the QSR and ISO requirements for supplier evaluation and assessment, and provide cost efficient, equally compliant options to many of the most common practices. Areas Covered in the Session: * Regulatory Requirements * Key Elements of a Supplier Qualification Program * Utilizing Quality…
BRC Risk Analysis - Webinar by GlobalCompliancePanel

BRC Risk Analysis - Webinar by GlobalCompliancePanel

Location: , United States
Category: Business and Economics
Start Date: 10-21-2010 Last Day: 10-21-2010
Risk Assessment is a fundamental and intuitive activity that is not new to manufacturing professionals. Bringing consciousness and tangibility to this process is the challenge often faced. A practical guide documenting the process will be the topic of this training. This presentation will take you step by step through the creation of each type of risk assessment required by the BRC. Process and product driven risk matrices will be presented. Sources of supporting documentation demonstrating the rationale utilized to arrive at conclusions will be provided. Quantification of risks and the progression to meaningful programs with defined goals. Why you should…
China Banking Risk Management International Summit 2010

China Banking Risk Management International Summit 2010

Location: , China
Category: Business and Economics
Start Date: 10-26-2010 Last Day: 10-27-2010
Many banks realized their weakness in risk management after experiencing the financial crisis. Now, European sovereign-debt crisis has evolved into another financial storm and credit crisis. The CBRC said in its annual report” The macroeconomic environment of 2010 is better than 2009,but there are still some factors of instability in banking risk management, such as the non-performing Loan, real estate credit , transmitted risk, liquidity risk ... must be paid attention to” 3rd annual China Banking Risk International Summit 2010 will be held in Beijing on Oct 26-27, 2010. During the 2-day event, the topic will focus on Basel II…
Medical Device Classification - Webinar by GlobalCompliancePanel

Medical Device Classification - Webinar by GlobalCompliancePanel

Location: , United States
Category: Business and Economics
Start Date: 10-26-2010 Last Day: 10-26-2010
In 1976, the FDA received authority to regulate medical devices. The plan, written into law, establishes three risk classes for devices (I, II, and III). The three risk levels require different types of control. The webinar explains the two dimensional system the FDA employs, classifying each device by risk class and associated panel. This leads to specific regulations for each device type. The EU’s MDD classifies devices using a rule based system found in Annex IX of the MDD. Devices fall into four risk categories (I, IIa, IIb, and III). The risk class of the device determines the available conformity…
The Most Common Problems in FDA Software Validation & Verification - Webinar by GlobalCompliancePanel

The Most Common Problems in FDA Software Validation & Verification - Webinar by GlobalCompliancePanel

Location: , United States
Category: Business and Economics
Start Date: 10-26-2010 Last Day: 10-26-2010
In August 2010, FDA made an announcement affecting virtually every drug, device and biologic firm marketing products in the U.S: "The Agency (FDA) will be conducting a series of inspections in an effort to evaluate industry's compliance and understanding of Part 11...The Agency intends to take appropriate action to enforce Part 11 requirements for issues raised during the inspections..." The statement clearly reflects the renewed FDA interest in examining industry compliance with regulations for electronic records and electronic signatures - and its willingness to aggressively pursue enforcement actions. This FDA Software Validation and Verification (V&V) training/webinar will review the validation…
2010 Consumer & Insights Summit (October 27th, 2010)

2010 Consumer & Insights Summit (October 27th, 2010)

Location: , China
Category: Business and Economics
Start Date: 10-27-2010 Last Day: 10-27-2010
Having a deeper insight into consumers and shoppers helps the business design the product better fitting the customers’ needs, communicate with the customers in the way they like, drive their buying behavior and improve customer satisfaction and loyalty. The topics will be focus on: 1. Understanding behavior of shoppers and defining effective ways to communicate with them 2. Market segmentation strategy with insights into customers' purchasing behavior and lifestyle 3. Keep Youth Insights Updated 4. Understanding media habit of target customers in different regions especially in low-tie cities 5. Using Consumers to Guide the Product Development Process The speakers are…
ICH Q7 Guidelines and Practical Approaches to Manufacturing APIs - Webinar by GlobalCompliancePanel

ICH Q7 Guidelines and Practical Approaches to Manufacturing APIs - Webinar by GlobalCompliancePanel

Location: , United States
Category: Business and Economics
Start Date: 10-27-2010 Last Day: 10-27-2010
Active Pharmaceutical Ingredient Good Manufacturing Practices (API GMP) are established and defined by the ICH Q7 Guidance. The international supply chain associated with API manufacturing was one of the greatest drivers for the development and international adoption of these expectations by regulators world-wide. The growth in the number of FDA inspections of API producers outside of the USA also played a major role in motivating international interest in the development of a "universal" API GMP. ICH Q7A Guidelines ( later renamed by ICH as Q7 ) and practical approaches will be examined during this program. All the sections contained within…
2010 Shopper Marketing Summit(October 28th,2010,Shanghai)

2010 Shopper Marketing Summit(October 28th,2010,Shanghai)

Location: , China
Category: Business and Economics
Start Date: 10-28-2010 Last Day: 10-28-2010
Shopper marketing is raising the attention of an increasing number of companies and accounts for a budget growing more than 21% annually. But how can the return justify its cost? In this summit, you are going to find out how the leading companies develop comprehensive shopper marketing strategies. The topics will be focus on: 1. The greatest challenge in creating shoppers into buyers 2. How to make the most of retail data and turn them into practical shopper marketing plan 3. Effective online shopper marketing strategy and the trend in online shopping 4. From insight to action The speakers are…
FDA's Update on Medical Device Labeling Changes

FDA's Update on Medical Device Labeling Changes

Location: , United States
Category: Business and Economics
Start Date: 10-28-2010 Last Day: 10-28-2010
FDA recently released a final rule regarding the parameters in which a device manufacturer can modify label changes to a product. Specifically, manufacturers can add or strengthen the contraindications, warnings, precautions or adverse reactions sections of labeling via a PMA supplement without prior FDA approval only when such modifications are based on newly acquired information and evidence of a causal association between the product and a safety signal is present. The rule also provides clarification as to what the Agency considers to be new information to be incorporated into a label change. Specifically, new information "must reveal risks of a…
BSR Conference 2010

BSR Conference 2010

Location: , United States
Category: Business and Economics
Start Date: 11-02-2010 Last Day: 11-05-2010
Innovation is crucial to building sustainable business success. But in our fast-changing world, innovation alone won't get the job done—it must be integrated into strategy and core business. This is what companies need to do to inspire and mobilize customers, employees, business partners, and other collaborators. Making this happen depends on gathering insights and ideas from a more diverse range of sources than ever before. Companies that understand our globalized, integrated, collaborative world will be best positioned to succeed. They will be the ones that capture increased market share and access to new markets through new products and services that…
21 CFR Part 11 - What you need to know to pass the new FDA audits - Webinar by GlobalCompliancePanel

21 CFR Part 11 - What you need to know to pass the new FDA audits - Webinar by GlobalCompliancePanel

Location: , United States
Category: Business and Economics
Start Date: 11-02-2010 Last Day: 11-02-2010
This webinar details the regulation and how it applies to computerized systems. Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach. 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.…
Project Management for the Phase 3 & LCM (Life Cycle Management) of the Drug Development Process - Webinar by GlobalCompliancePanel

Project Management for the Phase 3 & LCM (Life Cycle Management) of the Drug Development Process - Webinar by GlobalCompliancePanel

Location: , United States
Category: Business and Economics
Start Date: 11-02-2010 Last Day: 11-02-2010
This web seminar has been designed to provide you with a clear understanding of project management skills to apply to running phase 3 clinical trials. It will ensure you gain a clear understanding of the tools and techniques of project management for phase 3 clinical trials and how they can be applied to your own pharmaceutical projects in the work place. In addition to key project management tools and techniques a checklist of over 100 clinical trial activities for a phase 3 clinical trial will be supplied as part of the seminar, which will include the following: * Obtain a…
21 CFR Part 11 - Compliance for Electronic Records and Signatures - Webinar by GlobalCompliancePanel

21 CFR Part 11 - Compliance for Electronic Records and Signatures - Webinar by GlobalCompliancePanel

Location: , United States
Category: Business and Economics
Start Date: 11-02-2010 Last Day: 11-02-2010
This webinar details the regulation and how it applies to computerized systems. Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach. 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.…
2010 LAUSANNE INTERNATIONAL SPORTS MANAGEMENT CONFERENCE

2010 LAUSANNE INTERNATIONAL SPORTS MANAGEMENT CONFERENCE

Location: , Switzerland
Category: Business and Economics
Start Date: 11-04-2010 Last Day: 11-06-2010 Deadline for abstracts: 08-27-2010
The conference proposes the creation of an international and integrated learning and networking platform to allow for the presentation of the latest findings in sports management. The conference will: a) focus on research advances and practical solutions of sports management; and b) continue to expand on the learning, interactivity and networking dimensions of the event by involving a multi-dimensional and integrated approach (online and offline).
HIPAA Compliance and Workforce Training for Medical Practices` - Webinar by GlobalCompliancePanel

HIPAA Compliance and Workforce Training for Medical Practices` - Webinar by GlobalCompliancePanel

Location: , United States
Category: Business and Economics
Start Date: 11-04-2010 Last Day: 11-04-2010
Training is required in a number of areas of the HIPAA regulations and their policy implementations at medical offices. The HIPAA Privacy Rule includes basic protections of uses and disclosures of protected health information that every staff member must be aware of, from avoiding discussion of patient-related information outside of the office, to taking precautions when faxing information to another office. Beyond the use and disclosure provisions, there are requirements for allowing individuals to have access to their medical records and even asking for changes to their records or asking to have special restrictions placed on their records. If you…

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