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Regulation of printing inks on food contact packaging materials in the US & EU

Regulation of printing inks on food contact packaging materials in the US & EU

Location: , United States
Category: Education
Start Date: 09-15-2011 Last Day: 09-15-2011
Why Should You Attend: Packaged food worth millions of Euros has been recalled in Europe over the past four years as a result of the transfer of printing ink chemicals from the printed layer of packaging material into the packaged product. EU authorities have responded with new regulations and procedures intended to prevent such contamination. The US is likely to follow. In the US, users and producers of food packaging are responsible for insuring that no chemicals from printing inks migrate into the packaged product. With basic testing protocols for demonstrating that chemicals from these inks do not migrate into…
Pathogenic Escherichia Coli: Beyond E. Coli O157:H7 - A Food Safety Webinar

Pathogenic Escherichia Coli: Beyond E. Coli O157:H7 - A Food Safety Webinar

Location: , United States
Category: Education
Start Date: 05-05-2011 Last Day: 05-05-2011
Why Should You Attend: Recently a further strain of EHEC, E. coli O26, has been classed as an adulterant with consideration of other strains being added to the list. Pathogenic E. coli can be categorized into 6 main groups with Enterohaemorrhagic E. coli (EHEC), such as the O157:H7 strain being the most significant. There are 73,000 cases of E. coli O157:H7 reported annually within the US each year. E. coli O157:H7 was identified as a food-borne pathogen in 1982 and since this time further EHEC strains have been implicated in food-borne illness. Previously, only E. coli O157:H7 was classed as…
Good manufacturing practices for food contact packaging producers in the US and EU

Good manufacturing practices for food contact packaging producers in the US and EU

Location: , United States
Category: Education
Start Date: 04-26-2011 Last Day: 04-26-2011
Why Should You Attend: Food safety concerns in the supply chain arte driving global requirements for good manufacturing practices (both legal and contractual) in the way packaging material suppliers manufacture and market their products. Packaging suppliers must be ready to address both procedural and material changes in their operations and food processors must know what retailers will require of them in the case of a food safety alert. Food packaging producers for products sold in both the US and European Union are legally obligated to use “good manufacturing practices” (gmp) in producing their products. Additionally, contractual requirements for certifications to…
US FDA requirements for food contact packaging material compliance

US FDA requirements for food contact packaging material compliance

Location: , United States
Category: Education
Start Date: 07-07-2011 Last Day: 04-07-2011
Why Should You Attend: Food safety concerns in the supply chain arte driving global requirements for good manufacturing practices (both legal and contractual) in the way packaging material suppliers manufacture and market their products. Packaging suppliers must be ready to address both procedural and material changes in their operations and food processors must know what retailers will require of them in the case of a food safety alert. In this national climate of heightened awareness of food safety, more FDA inspections of food processing facilities is a certainty. During those inspections, processors are required to provide letters of continuing guarantee…
Salmonella: Evolution, Epidemiology, Detection and Control

Salmonella: Evolution, Epidemiology, Detection and Control

Location: , United States
Category: Education
Start Date: 04-14-2011 Last Day: 04-14-2011
Why Should You Attend: There are approximately 1.4 million of cases of salmonellosis each year within North America with at least 220 cases per 1000 requiring hospital treatment. Although the actual number of cases of salmonellosis is lower than that of Campylobacter, the pathogen accounts for 1000 – 2000 deaths each year. As our knowledge on Salmonella increases it has become apparent that the enteric pathogen is very adaptable to different environments and can contaminate a diverse range of foods. In addition to the traditional vehicles such as eggs and poultry, Salmonella has been linked to chocolate, peanut butter and…
Understanding ISO 22000:2005 - Webinar By ComplianceOnline

Understanding ISO 22000:2005 - Webinar By ComplianceOnline

Location: , United States
Category: Education
Start Date: 04-07-2011 Last Day: 04-07-2011
Why Should You Attend: The abundance of food safety schemes worldwide has led to uneven application of food safety standards, confusion regarding requirements, and increasing complexity and costs to suppliers that are obliged to conform to multiple programs. Individual companies and food industry groups have also developed, published and adopted their own standards under the Global Food Safety Initiative (GFSI). Depending on the size and scope of a given company’s business, it may be responsible for knowing and applying the rules and standards of multiple countries and industries. The international Food Safety Management Standard ISO 22000:2005 was developed in response…
Advancements in Approaches to Decontaminate Food Surfaces

Advancements in Approaches to Decontaminate Food Surfaces

Location: , United States
Category: Education
Start Date: 04-05-2011 Last Day: 04-05-2011
Why Should You Attend: Surface decontamination of foods is a key intervention for enhancing the shelf stability and microbiological safety of commodities such as meat or vegetables. The challenge of surface decontamination is how to achieve the highest log reduction of microbial populations with adversely affecting the sensory quality of the external and internal characteristics of foods. The entry will describe thermal and non-thermal approaches available for food surface decontamination. Of the thermal methods, steam or hot water remain the most common methods applied although Infrared and air heating can also be applied. Current research efforts are devoted to non-thermal…
The latest FDA and EMA hot area for citations, warning letters and other actions

The latest FDA and EMA hot area for citations, warning letters and other actions

Location: , United States
Category: Physical and Life Sciences
Start Date: 08-11-2011 Last Day: 08-11-2011
This training will provide valuable assistance on how to avoid costly regulatory action from agencies when they inspect your facilities in pharmaceutical and biotech industries. It will show you how to assess your systems and bring them into compliance. Areas Covered in the seminar: The various types of deviations, discrepancies, Out of Specification and Out of Trends, action limits and alerts. The impact of these excursions on your operations and product. To identify the lightning rods that will lead the inspector to scrutinize your reports and investigations. To differentiate planned and unplanned deviations and manage them appropriately to your advantage.…
Identifying risks and building a more compliant and successful trial

Identifying risks and building a more compliant and successful trial

Location: , United States
Category: Physical and Life Sciences
Start Date: 07-28-2011 Last Day: 07-28-2011
Description The field of GCP has rapidly evolved over the last 5 years and the requirements are getting tougher. Many companies find themselves unprepared for an FDA or EMEA inspection either at a clinical site or their headquarters. To prevent the surprises, early preparation is essential. Define expectations, train your staff and hold them accountable and the inspection will be easy to manage. This webinar will describe proactive measures you can take to assure that all systems are in place, operating well and operating in compliance. This will result in trials running smoothly, data being valid and giving your drug…
A Comparison of ICH Q-10 Quality System and the FDA’s Quality Systems Approach (QSA) to the Pharmaceutical cGMPs

A Comparison of ICH Q-10 Quality System and the FDA’s Quality Systems Approach (QSA) to the Pharmaceutical cGMPs

Location: , United States
Category: Physical and Life Sciences
Start Date: 05-05-2011 Last Day: 05-05-2011
Why Should You Attend: The ICH and FDA guidance documents on Pharmaceutical cGMPs stress the importance of management's responsibility to meet customer needs by encompassing quality improvement through quality by design (QbD), risk management, process control, and user feedback and experience. This new paradigm forces industry leaders as well as the FDA to rethink their roles in this dynamic regulatory-business environment. Here, quality principles trump the dictates of compliance. If your company fails to respond to this new calling, it may not be able to compete effectively in the marketplace. These quality concepts are based on well-known and tested quality…
Develop appropriate validation activities to meet to meet U.S. FDA, ICH Q9 and ISO 14971

Develop appropriate validation activities to meet to meet U.S. FDA, ICH Q9 and ISO 14971

Location: , United States
Category: Physical and Life Sciences
Start Date: 04-28-2011 Last Day: 04-28-2011
Why Should You Attend: A Validation Plan is the backbone of a company's validation activities and provides a clear and concise plan for complying with 21 CFR Part 11. The categorization of software determines the validation activities to be followed. In this webinar, we will discuss the five categories of software and also focus on the activities required for validation. Examples of each category and activities will be discussed and frequently asked questions will be answered (e.g. Do I have to validate an Excel Spreadsheet?) The components of the Validation Plan will be identified and activities describing timing and roles/responsibilities…
Establishing a Reduced Testing Program for Pharmaceutical & Medical Device Components

Establishing a Reduced Testing Program for Pharmaceutical & Medical Device Components

Location: , United States
Category: Health and Medicine
Start Date: 04-28-2011 Last Day: 04-28-2011
Why Should You Attend: The FDA has begun to more closely scrutinize the industry’s effort in the qualification of suppliers and contractors. This is particularly true in the qualification of the supplier for a reduced testing program. When properly administered, a reduced testing program lowers the cost of testing and provides a higher level of quality. The principles for pharmaceuticals and medical devices are the same but there are some differences due to the nature of the products. This course will help you understand FDA expectations for reduced testing of components and will develop your confidence in maintaining control of…
Designing Medical Devices for Patient Safety

Designing Medical Devices for Patient Safety

Location: , United States
Category: Health and Medicine
Start Date: 06-20-2011 Last Day: 06-20-2011
Why Should You Attend: Medical devices represent a significant sector of the U.S. healthcare industry, with annual sales exceeding $13 billion. These devices, including pacemakers, cardiac defibrillators, infusion pumps, and neural stimulators, have unacceptably high failure rates. Missing safety requirements in the product specification are often the source of harm to patients. For next-generation devices, which are much more complex, we must include robustness requirements in the specifications through hazard analyses during the concept stage. FDA approval hinges on demonstrated safety and the reliability of the safeguards. Including safety requirements early reduces the time to market. Attend this webinar to…
Sterilization Options for Challenging Products

Sterilization Options for Challenging Products

Location: , United States
Category: Health and Medicine
Start Date: 08-18-2011 Last Day: 08-18-2011
Why Should You Attend: Medical products are more complicated and have greater challenges for sterilization process than ever before. These products might include tissue-based products, combination products, devices with drug coatings, devices with batteries or equipped with integrated software, circuits or computer chips. Each of these present their own challenges for sterilization starting with selecting a compatible process to developing the validation strategy and meeting the regulatory requirements for ensuring that the sterilization process is adequate for the medical product. Making a mistake can be costly not only in immediate costs but also in project delays and potentially in regulatory…
How to investigate environmental monitoring excursion limits

How to investigate environmental monitoring excursion limits

Location: , United States
Category: Health and Medicine
Start Date: 05-12-2011 Last Day: 05-12-2011
Why Should You Attend: Medical products are manufactured in environments that are designed to control the level of viable and non-viable particulate and these environments must be monitored to establish that the control measures are continuing to perform acceptably including the impact to product bioburden. You need to establish appropriate limits for ongoing monitoring so it is critical that you know how to set these limits. But once these limits have been set it is also critical for you to know what actions need to be taken to determine if there is product impact or other implications to the manufacturing…
Bringing Compliance to Design Control for Older Products

Bringing Compliance to Design Control for Older Products

Location: , United States
Category: Health and Medicine
Start Date: 04-29-2011 Last Day: 04-29-2011
Why Should You Attend: Many regulated companies have not brought their old products up to the new FDA standards and are not in compliance. This webinar defines the criteria to be used for medical products design history file remediation. For example companies should be compliant to 14971:2007. Design History Files need to be adjusted to meet the new standards. The FDA expects risk management to be integrated into the company quality system. Old medical devices need to have a risk assessment for each product. Each product needs to have a gap analysis to determine obsolescence or validate. It should also…
The FDA’s final (MDDS) rule and its implications for currently regulated and unregulated vendors and providers

The FDA’s final (MDDS) rule and its implications for currently regulated and unregulated vendors and providers

Location: , United States
Category: Health and Medicine
Start Date: 04-28-2011 Last Day: 04-28-2011
Why Should You Attend: The FDA signaled a shift from regulatory discretion to enforcement discretion regarding Medical Device Data Systems (MDDS) with the publishing of the final rule on February 14, 2011. Ostensibly, the FDA reclassified these systems from Class III to Class I. But the most remarkable consequence from the final rule is naming of specific entities that may be subject to potential FDA enforcement actions. The rapid adoption of Electronic Medical Records, advent of Meaningful Use and subsequent desire to automatically acquire medical device data for inclusion in electronic records has resulted in the development and adoption of…
The Drug Repositioning Conference

The Drug Repositioning Conference

Location: , United States
Category: Physical and Life Sciences
Start Date: 07-13-2011 Last Day: 07-14-2011
Arrowhead’s Drug Repositioning Conference has been organized to highlight key trends, case studies and tool sets for identifying repositioning opportunities as well as the technical, regulatory and intellectual property challenges that arise out of these efforts. At the conference, we will highlight the following topics: *Intellectual property issues relating to new use of known drugs *Tool sets for identifying repositioning opportunities *Regulatory issues/timelines and legal frameworks for drug repositioning *Product lifecycle management through new drug indications *Re-tasking currently marketed drugs through combination therapy *Case studies *Market potential of drug repositioning *Technical challenges of drug repositioning
i-KNOW 2011 - 11th International Conference on Knowledge Management and Knowledge Technologies

i-KNOW 2011 - 11th International Conference on Knowledge Management and Knowledge Technologies

Location: , Austria
Category: Computer Science and Internet
Start Date: 09-07-2011 Last Day: 09-09-2011 Deadline for abstracts: 04-30-2011
i-KNOW 2011 brings together international researchers (in the English speaking i-Science Track) and practitioners (in the German speaking i-Praxis Track) from the fields of knowledge management and knowledge technologies. Opening and closing keynotes and a conference-wide Exhibition complete the i-KNOW conference program. i-KNOW 2011 will cover relevant aspects of knowledge management and knowledge technologies in the following fields of research: * Knowledge Management * Knowledge Discovery * Knowledge Services * Social Media * Enterprise 2.0 and the Social Web The Conference Proceedings of i-KNOW 2011 will be published by ACM
Pharmaceutical Nanotechnology: Applications & Commercialisation

Pharmaceutical Nanotechnology: Applications & Commercialisation

Location: , United Kingdom
Category: Health and Medicine
Start Date: 06-29-2011 Last Day: 06-30-2011
SMi’s is proud to present their Pharmaceutical Nanotechnology: Applications & Commercialisation conference taking place in London on June 29th and 30th, 2011. This event will explore the progression in this fascinating area and discuss the steps necessary to apply its virtues to current therapeutics and develop commercially successful products. Key Presentations Include: The business case for nanotechnology Thomas Keller, Director, Open Innovation, GlaxoSmithKline Miniaturisation and modelling of beads milling Mostafa Nakach, Head of Pharmaceutical Engineering Group, Sanofi-Aventis R&D Investigation of chitosan nanoparticle formulations Michael Keller, Senior Fellow, siRNA Project Leader, Technical Research and Development (TRD), Novartis Pharma Enabling oncology drug…

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