Physical and Life Sciences

The FDA continues to change its import program to better manage new problems and to use new procedures to make the whole process easier. The FDA and U.S. Customs and Border Protection (CBP) are relying more and more on computer programs to expedite the import process. When and how you use these programs can make a big difference in the net profit derived from even a single shipment. The new Voluntary Qualified Importer Program (VQIP) is one such example. Another example is CBP’s and FDA’s implementation of the Automated Commercial Environment (ACE) program became mandatory for importers in 2016. If…

FDA inspection and oversight of quality control (QC) laboratories are essential elements of the agency’s evaluation of the compliance status of regulated companies representing multiple industries - pharmaceuticals, biologics, medical devices, as well as foods and cosmetics - as well as the contract QC laboratories which service these industries. Lack of compliance can result in severe regulatory actions, criminal liability, fines, and the inability to obtain product approvals. This course will examine the fundamental requirements for all QC laboratories subject to FDA inspection, recent trends from FDA inspection reports and enforcement actions. In addition, this course will include a list…

Because a phase 1 clinical trial initially introduces an investigational new drug into human subjects, appropriate CGMP help ensure subject safety. It is important to implement quality control (QC) principles to the manufacture of phase 1 investigational drugs (i.e., interpreting and implementing CGMP consistent with good scientific methodology), which foster CGMP activities that are more appropriate for phase 1 clinical trials, improve the quality of phase 1 investigational drugs, and facilitate the initiation of investigational clinical trials in humans while continuing to protect trial subjects. The following steps to establish the appropriate manufacturing environment for phase 1 investigational drugs should…

8th International Conference on Brain Injury and Neuroscience About Conference On behalf of the Conference organizing Committee we would like to cordially invite all for the 8th International Conference on Brain Injury and Neuroscience held during March 14-15, 2019 in Paris, France. Theme: New Inventions in the field of Brain Injury and Neuroscience Brain Injury 2019 Conference will serve as an extraordinary platform to engage in stimulating discussions, information exchange and perceiving new ideas in the field of Brain Injury and Neuroscience. These meetings provide a composite open atmosphere, allowing attendees and speakers to easily focus on academic exchange of…

5th International Conference on Pollution Control & Sustainable Environment About Conference Conference Series llc LTD takes immense pleasure to extend our warm welcome to invite all the participants from all over the world to attend 5th International Conference on Pollution Control & Sustainable Environment during March 14-16, 2019 at London, UK which will entail lively debates, prompt keynote presentations, Oral talks, Poster presentations, workshops and networking opportunities around a core of plenary and concurrent sessions based on essential topics in the Pollution Control sector. Pollution Control 2019 conference is organizing with the theme of “Scientific Challenges and Brilliance of New…

Quality Control Laboratory Compliance - cGMPs and GLPs *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! ***REGISTER TODAY! FDA inspection and oversight of quality control (QC) laboratories are essential elements of the agency’s evaluation of the compliance status of regulated companies representing multiple industries - pharmaceuticals, biologics, medical devices, as well as foods and cosmetics - as well as the contract QC laboratories which service these industries. Lack of compliance can result in severe regulatory actions, criminal liability, fines, and the inability to obtain product approvals. This course will examine the fundamental requirements for all QC laboratories subject to…

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies. Reformatting for multiple submissions is substantially limited. The CTD has improved the regulatory review processes and enabled implementation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times. This two day workshop will provide you with an in-depth review of the content and format requirements of the CTD/eCTD.…

Save the date to attend the SLAS 2019 European Sample Management Symposium, March 11-12, 2019, in Berlin, Germany. Sample management has become increasingly important in every phase of chemical and biological discovery. Control over factors like sample quality, process efficiency, metadata and miniaturization must be achieved to accelerate both academic and industrial programs. Further complexity arises in maintaining these factors when collaborating with an external research partner. The 2019 SLAS European Sample Management Symposium welcomes all compound and sample management professionals – from bench scientists to senior leaders – to obtain fresh perspectives and share innovative solutions to challenges in…

"We are so glad to organize “16th International Conference on Structural Biology” in Bali, Indonesia on March 11-12, 2019 at Bali, Indonesia with the theme “ Exploring recent trends of Structural Biology.” Structural Biology Meet 2019 is a 2-day event offering the Exhibition, at the venue to showcase the new and emerging technologies and have wider sessions involving Keynote presentation, Oral, YRF (student presentation), poster, e-poster presentations. World-renowned speakers and eminent delegates across the globe attending the conference, to share their valuable presentation on the most recent and advanced techniques, developments, technologies, clinical trials in Structural Biology and relevant topics…

Main Attractions: 1.Famous professor as Keynote Speaker Dr. Wei Yu, from The University of Auckland, New Zealand Prof. Alina Butu, from National Institute of Research, Bucharest, Romania; Assoc.Prof. Tomas Navratil, from J. Heyrovsky Institute of Physical Chemistry of the CAS, Czech Republic. 2. Academic Visit There will be a one-day academic visit in The University of Auckland and Auckland on March 08, 2019. 3. Publication and index Accepted and registered papers will be published in: International Journal of Pharma Medicine and Biological Sciences (IJPMBS, ISSN 2278-5221), which can be included in and indexed by Embase; ProQuest; International Committee of Medical…

This course will give an introduction into the Medical Device Single Audit Program (MDSAP). The introduction will give an overview about the program definition, the requirements for the quality management system, how a smart implementation of these requirements in the quality management system is possible and finally how the audit for five countries (Australia, Brazil, Canada, Japan, US) is working. Learning Objectives: What is the Medical Device Single Audit Program (MDSAP)? Which Companies must have MDSAP? Which Companies should have MDSAP? Which Companies should postpone MDSAP? What are the requirements of MDSAP? How to implement MDSAP in a smart way…

The course is designed for Medical Products Manufacturers. The course will be taught for Medical Devices and Combination Products, but will also be of benefit to Pharmaceutical Manufacturers. Learning Objectives: Upon completion of the course, the participants will have learned how to implement good risk management principles into medical products manufacturing operations such as medical devices, combination products, and pharmaceuticals: Understand what are the current issues and recommended solutions How to implement the ISO 14971 framework Use a Traceability Report for improved risk management operations How to Use Standards to Facilitate Product-to-Market Achievements How to Use Risk Management to Identify…

All facilities manufacturing pharmaceuticals, biologics, medical devices, cosmetics, and personal care products are likely to have high purity water systems. In spite of this purity, microorganisms can flourish within these systems and lead to undesirable contamination of facility processes and their products. Of all the individuals at the facility, it is site’s microbiologists who should understand the microorganisms in water systems and how best to monitor and control them. Sadly, this is often not the case due to the lack of familiarity with biofilm and its impact on water system sampling, testing, sanitization, and routine maintenance. This lack of understanding…

Every biopharmaceutical company has SOPs, and new staff members are told that the company “has to have them” and that each employee “has to follow them”. But why do there have to be SOPs and why must we follow them as written? And how can we do this effectively? Most people naturally want to do a good job. Successful managers recognize this fact and seek to channel workers' efforts in ways that will benefit the business. Well-written standard operating procedures (SOPs) provide direction, improve communication, reduce training time, and improve work consistency. The purpose of a SOP is to provide…

5th International Conference on Mental Health and Human Resilience About The Conference Conference Series LLC Ltd is one among the major open access platforms which organizes a series of 3000+ International Events with 800+ international conferences every year across USA, Europe, & Asia. With a great support from 1000+Scientific societies, world renowned scientist, Noble Laureates, scholars and students, we have reached 25 million professionals and corporate entities all over the globe. With a great pleasure we proudly present “5th International Conference on Mental Health and Human Resilience” .Conference mainly focus on Psychiatry and Mental Health disorders and therapies. International Conference…

This webinar will provide a general overview of the cell-based methods using process controls as well as specific examples of successful monitoring of cell-based methods leading to reduced assay failures.

The energy storage market and development brings as many challenges as it does advancements, with a myriad of technologies, capacities, functions, and lifespans. With most projects still in development and technologies with sparse track records, knowledge in this fledgling industry is invaluable. Investors, utilities, consumers, and all renewable energy participants have to not only understand the market, but be able comfortable enough to make the right investment in energy storage to not be left behind the curve. Our event is the platform for companies to bridge the gap between "future energy storage plans" and "installed energy storage". Join us to…

Join us in Miami at the 12th Argus Americas Asphalt Summit to discuss the impact of the new marine fuel specification, one of the largest market disruptors the energy industry has seen in decades. We are gathering refiners, asphalt blenders, traders, wholesalers, transporters, terminal operators and contractors to look at the specific market implications of this unprecedented shift and its potential impact on the quality, supply and pricing of asphalt. (header) Explore the effect of IMO on your business, including: • Implications on asphalt quality and the effect on additives • Changes on global asphalt movements • Contract strategies prior…

The growth of the medical software industry outpaces the design of FDA's regulatory process. In some instances clinicians have weighed the risk of software failure against the benefits of using a device at all. Device software is often used in conjunction with other software-based devices, but their interoperability was never anticipated. How can you anticipate and defend against the malicious remote hacking and shut down of an insulin infusion pump? Can one software program defeat the performance capability or back up safety features of another software program? When interoperability surface, which software manufacturer takes the lead to solve the problem…

With an 11 year legacy in Europe and twinned with PV Operations Europe, the Wind OandM 2019 conference is the must attend O and M event of the year. Wind OandM Europe is the #1 meeting point for Europe's senior OandM executives. The 2019 event draws in major asset owners and operators to discuss alongside innovative vendors the latest and greatest updates to the industry. Meet and learn from Utilities, owner operators, IPPS, Asset management, Investors, Data companies, ISPs, OEMs, Blade/gearbox/service companies. Meet OandM manager, Opertations manager, maintenance, optimisation, country manager, head of onshore, data lead, vp digital, URL: Tickets:…