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…

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…

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…

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…

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…

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…

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.…

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…

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…

Medical device firms need to be aware of the benefits of compliance as well as the dangers of inadequate complaint handling. This Webinar will explain the regulatory process and in understandable terms. Many medical device firms face regulatory issues as a result of inadequate complaint handling. FDA has explicit complaint handling requirements and poor complaint & reporting procedures often result in costly recalls and warning letters. FDA warning letters and recalls are posted on FDA's website and published in trade magazines, newspapers available to firm's competitors, and has even driven the firm's stocks down. This presentation will review the regulations…

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…

Auditing is a critical function of a medical product company. It provides management with information about how effectively a company controls the quality of their processes and products. Auditors must perform their jobs competently to ensure their company's compliance with pharmaceutical GMP regulations and other quality standards. This course provides information to increase an auditor's ability to audit in a professional and knowledgeable fashion using a wide variety of hands-on activities and teaching methods. This course will contribute to the improvement of auditor performance within a regulated industry. Participants will learn how to prepare for more effective audits, conduct audits,…

Back for the 6th edition, SCM Logistics World 2010 brings together senior supply chain & logistics professionals from across key manufacturing verticals, vendors and solution providers at one strategic platform to discuss the current and hot topics concerning the supply chain and logistics function in the industry. Under the SCM Logistics World 2010 are 4 key manufacturing verticals- Hightech, Retail & CPG, Chemical & Oil & Gas and Industrial & Heavy Machinery.

SCM Logistics World Retail & CPG 2010 brings together senior supply chain & logistics professionals from top Asian and global retailers and CPG manufacturers, vendors and solution providers to discuss current issues faced by the supply chain and logistic functions. The targeted Retail & CPG conferences would offer more than 25 pertinent case studies to facilitate sharing of experiences and ideas from Top 500 and Asian 500 CPG/Retail manufacturers. In addition, the attendees can expect insightful learning from the Demand Forecasting Forum and Open Dialogue among the suppliers, retailers and manufacturers. Thus, this conference would provide an excellent avenue for…

SCM Logistics World Chemicals, Oil & Gas 2010 brings together senior supply chain & logistics practitioners, vendors and solution providers from the industry to discuss current issues faced by the supply chain and logistic functions. The targeted Chemical, Oil & Gas conferences would provide attendees a once-a-year opportunity to meet top leaders from the common industry, and exchange some of the insights and knowledge they have in streamlining their business processes. In addition, there would be more than 25 pertinent case studies from leading Asian and global practitioners.

SCM Logistics World Industrial & Heavy Machinery Manufacturing 2010 brings together top Asian and global supply chain & logistics professionals, vendors and solution providers to discuss current issues faced by the supply chain and logistic functions of the heavy manufacturing industry. The targeted Industrial & Heavy Manufacturing conferences would offer more than 25 pertinent case studies to facilitate sharing of experiences and ideas from Top 500 and Asian 500 heavy manufacturers. Thus, this conference would provide an excellent avenue for retailers and suppliers to learn of new strategies and supply chain methodologies.

Conference Details: Main Conference Days: 12th – 13th October 2010 Post Conference Workshop: 14th October 2010 – 10.00 – 16.00 Location: CCT Canary Wharf, London, United Kingdom Conference highlights include: • Enhanced Design & Delivery: Hear how leading Architects, Engineers & Developers are working more effectively to deliver façade projects within time, in budget & to requirements, through case studies from the Docks de Paris, the Curve in Leicester & the Villamar Towers in Bahrain • Sustainability & Environmental Impact: Learn the latest methods & strategies to help your organisation achieve its sustainability goals including expert briefs on minimising energy…

The FDA QSR requires device manufacturers to validate processes when the manufacturer cannot "fully verify the output". The manufacturer must validate these processes with a "high degree of assurance". The presentation explores the statistical underpinnings of these two phrases. To "fully verify the output" relates to the use of statistical sampling plans, while "high degree of precision" relates to process capability. The presentation illustrates the statistical concepts. The Global Harmonization Guidance document on process validation shows the application of statistical techniques. In particular, the guidance explains the use of design experiments (DOE) to establish process parameters and develop challenge points…

Call for paper The International Conference on Entrepreneurship 2010 (ICE 2010) approach focuses on the entrepreneurship research from theoretical and practical perspective using English, Arabic and Malays as the medium of presentations. Broadly, the main areas of inquiry include the followings but not limited to: 1. Conceptual and Theoretical Aspects of Entrepreneurship, 2. Entrepreneurship in Emerging Economies, 3. Entrepreneurship Environment and Support, 4. Small Business Management, 5. Socio-behavioral, Cognitive, and Cultural Analysis of Entrepreneurs and Entrepreneurship 6. Entrepreneurial Organization 7. Entrepreneurial Management 8. Leadership 9. Any other related areas pertaining to any issue which is related to entrepreneurial aspects such…

Focuses on the entrepreneurship research from theoretical and practical perspective using English and Malay as the medium of presentations. visit http://www.internationalconference.com.my or email at: ice@internationalconference.com.my