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…

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…

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…

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 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…

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.…

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…

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.…

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).

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…

Climate change, policy stimulation, consumption quota of renewable energy and cost down, those four factors impel the rapid development of global photovoltaic industry. In global market, the photovoltaic industry has been driven by grid-connected power generation. The market share of grid-connected photovoltaic systems also has increased from 50% to more than 90%. Ministry of Finance and Ministry of Housing and Urban-Rural Development of the People’s Republic of China unveiled two subsidy policies “Solar Roofs Plan” and ”Golden Sun” on March 26, 2009 which opened the domestic market of photovoltaic system application, and also brought the new business opportunity for domestic…

There is confusion between the requirements for Design Verification, Process Validation and Design Validation. While each of these processes has its own requirements, they do not stand alone, they are linked together. As this linkage is not well understood, it is the source of FDA observations and potential release of products that do not meet requirements. Areas Covered in the Session: * Requirements for Design Verification. * What is "successful Design Verification"? * Requirements for Process Validation * What are the inputs to Process Validation from Design? * What are the requirements for Design Validation? * Where do I get…

This program will focus on the basics needed to perform an API audit. Performing an audit is not simply an act of visiting a firm and checking off a list of questions. Auditing API producers and suppliers is an important part of GMP compliance programs. Identifying what approach or process to use is examined and the tools to utilize during an audit is also discussed. Audits at best are snapshots of what exists at the moment of the audit; however, a good audit or auditor will be able to uncover the less obvious signals and signs of concern. Learn what…

Most industries have become reasonably sophisticated in terms of applying the principals and tools involved in quality control and improvement. Unfortunately, food supply chain members have lived outside of the quality world and have not invested the time, training or money to learn and apply the disciplines needed to bring quality into preventive levels of control. Visual inspection in many industries has long ago been rejected as a means of quality improvement since it is expensive and does not focus on continuous improvement, causal analysis or prevention. Unfortunately the emphasis on visual inspection has dominated the food supply chain as…

To satisfy QSR and ISO 13485 requirements as well as produce quality products, companies must assure personnel are trained on their routine job practices as well as familiar with requirements that impact them. A complete and effective employee training program must be in place to assure this. This session will instruct attendees on the regulatory requirements of personnel training, and establishment of a training program, including new employee training, methods of training, how to document training so that it is readily available for review (by managers, auditors or inspectors), when to evaluate training requirements, training effectiveness, and when training is…

IEC 60601-1 Third Edition was released in late 2005. It is a new philosophy in standards for medical electrical devices to accommodate rapid advances in technology. This new philosophy has been difficult for test houses and compliance bodies to absorb and develop test strategies. Currently, the EU and Canada have announced May 31-June 1, 2012 as the date when the Second Edition will be withdrawn. Devices that will be released after that date must meet the requirements of the Third Edition. Manufacturers with products under development must start now to develop compliance strategies. The first step will be understanding the…

FDA issued a guidance document covering GMP requirements for Phase 1 products. These guidelines remove some of the problems that are encountered with early phase products and are in addition to those that cover the CMC sections for IND submissions at Phase 1. Although the guidance appears to remove the need to follow GMPs for Phase 1 products, the need to follow GMPs is still present in the Food, Drug, and Cosmetic Act. Thus the nature and extent of GMP-related activities will depend upon the nature of the investigational drug and the extent of the study that is planned. This…

This webinar covers the statistical methods used to calculate sample sizes for both attribute and variables data. Methods for collecting the sample will be covered. Every sampling plan has risks. This webinar covers how to calculate Type I and Type II errors. A discussion of how the FDA views sampling plans, especially for validation and acceptance activities. Sample size to ensure a certain level of process capability will be covered. Areas Covered in the Session: * How to collect a sample * What are the two types of error (Type I and Type II) * How to calculate sample sizes…

The theme: Tackling Technical and Operational Bottlenecks, Speeding Up Infrastructure Investment In 2010, along with the progress of “New Energy Vehicle Development Plan” and “Electric Vehicle State Standardization”, China, as the world’s most potential markets, is entering a new energy vehicle era. The “Automotive Industry Restructuring and Revitalization Plan” announced in March 2009 has made it clear that a production capacity goal of 500, 000 new energy cars must be formed by the year 2012. The automakers are launching their own brands of new energy vehicles. Auto professionals believe that infrastructure construction is more important than auto technologies since it…

Attend and: Get a clear understanding on how to become a great HRBP Benchmark which skills & competences to develop Get confidence and credibility in successful partnering Network with HRBP’s from all over Europe Become a valued Strategic Partner Gain knowledge on how to influence senior level managers Become the trusted advisor of your internal clients Set clear objectives and goals for your role Dave Ulrich will be holding a 2h30 Workshop Most influential person in HR (HR Magazine) for 3 years #1 Management Educator & Guru (BusinessWeek) One of the 10 most innovative and creative leaders (Fast Company) Speakers…