Health and Medicine

ExL's 9th Aggregate Spend and Open Payments Conference has been the industry's premier event for strategies to optimize transparency reporting for compliance programs for almost a decade. This year, we will explore compliance theories about how to match transparency-reporting processes with continually evolving business systems and promotional activities. URLs: Brochure: https://go.evvnt.com/214426-1?pid=154 Booking: https://go.evvnt.com/214426-2?pid=154 Time: 8:00 am to 6:00 pm Prices: Early Bird Pricing — Register by May 4, 2018: USD 1895, Standard Pricing: USD 2095, Onsite Pricing: USD 2195

The growing biotech industry has led to an increasingly competitive and saturated marketplace, and with it, greater competition for face time with premier thought leaders. Coupled with the scrutiny associated with industry partnerships and the challenges of managing KOL relationships in a post-Sunshine Act world, it is imperative for life science organizations to differentiate themselves from their competitors in the marketplace while aligning company objectives across their internal organization. The 9th KOL/Thought Leader Engagement and Advisory Boards Summit will provide attendees with valuable insights into engaging traditional and non-traditional KOLs and discuss the priorities and motivating factors for patient groups,…

Overview: Among those educational requirements are a course in Introductory GMP upon employment at a pharmaceutical company, and annual refresher GMP training. Why should you Attend: The laws that govern Good Manufacturing Practices (GMP) are a cornerstone of pharmaceutical production. Still, many companies fall short of the requirements that are written into US, UK, European and other laws, which can have disastrous consequences for patient health and a company's reputation, not to mention the resultant losses in revenue due to fines, declining sales and withdrawal of products from the market. Areas Covered in the Session: Food and drug oversight Pivotal…

as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Engineers are dedicated to making things work, so a focus on how they might fail and harm someone can seem alien. Managing risk, however, is essential for all medical products- medical devices, including those involving software, have produced some painful examples of poor risk management with serious consequences. Experience has shown that there is a better way, that it is possible to manage risk in a changing business and technical world. Regulatory bodies are placing increased emphasis on risk management, and technology shifts are…

This webinar provides an overview of the Quality Management System requirements. We will discuss ISO Quality Management standards and the FDA Quality System requirements. Medical device companies are utilizing ISO standards to build their business management systems because of their benefits and as a necessary step to market their products globally. Areas Covered in the Session : >. Understand the Quality Management Principles >. Discuss the benefits of an effective QMS >. Review the Quality Essentials >. Procedure Development >. Understand the required documentation: >. Quality Manual >. Policies >. Procedures >. Work Instructions Who Should Attend: >. Quality Associates…

“In aseptic processing, one of the most important laboratory controls is the environmental monitoring program. This program provides meaningful information on the quality of the aseptic processing environment (e.g., when a given batch is being manufactured) as well as environmental trends of ancillary clean areas. Environmental monitoring should promptly identify potential routes of contamination, allowing for implementation of corrections before product contamination occurs.” Why You Should Attend: This webinar will first explain the various US and international regulatory requirements for various clean room classifications, as well as the environmental monitoring of clean room environments. Next, the presentation details the benefits,…

Environmental Monitoring looks at the end results of the Environmental Control program – the microbiological and particulate quality of the clean room. As the FDA Guideline on Aseptic Processing GMP (2004) states: “In aseptic processing, one of the most important laboratory controls is the environmental monitoring program. This program provides meaningful information on the quality of the aseptic processing environment (e.g., when a given batch is being manufactured) as well as environmental trends of ancillary clean areas. Environmental monitoring should promptly identify potential routes of contamination, allowing for implementation of corrections before product contamination occurs.” Why You Should Attend: This…

This 510(k) training will discuss the submission process and the contents required by the FDA for a successful 510(k) submission. It will also provide an understanding of the common pitfalls, delays, and possible preventive measures. This Medical device training will provide an understanding of how to get a device requiring a 510(k) submission to market quickly. Knowing when and how to properly submit a 510(k) for a device or change to a device is critical to a company’s regulatory and financial health. Your goal is to get the 510(k) through the review process as quickly as possible. Areas Covered in…

This webinar discusses methods for estimating process capability for both normal and non-normal data. Pre-requisites for estimating process capability (e.g. establishing process stability) are discussed first. Distributions are briefly described and methods for estimating ppm levels are presented. The use and limitations of common process capability indices (e.g. Cpk and Ppk) are discussed. It is vital that appropriate methods are used for estimating capability when the data is not well described by a normal distribution. Failure to do so often results in overly optimistic process capability estimates. Methods for testing for normality are discussed. Both transformations and distribution fitting are…

Co-located with Next Generation Protein Therapeutics, Cell Line Development And Engineering, June 12-14, 2018 in San Francisco, CA is the event trusted by industry and academic alike. You will hear how peers are overcoming common challenges, implementing new technologies and realizing efficiency gains while working with establishing and developing cell lines. Special All Access Pass allows you entry to both events. Prices: Industry - All Access Pass: USD 2499 Industry - Cell Line Development Only: USD 2099 Academic - All Access Pass: USD 1099 Academic - Cell Line Development Only: USD 699 Speakers: Martina Baumann, Mara Pavel-Dinu, Elizabeth H. Scheideman,…

The 13th Annual Next Generation Protein Therapeutics and Bioconjugates Summit delivers the very latest results from an ever-expanding number of multifunctional molecules in development and offers you the best opportunity to learn from world-renowned academics and industry visionaries who are expanding the frontiers of biologic drugs. Hear from the best and the brightest speakers spanning across industry and academia: FDA Feedback: Regulatory Guidance and Expectations for Next Generation Protein Therapeutics and Bioconjugates Presented by: Christopher Sheth, Supervisory Pharmacologist, Division of Hematology Oncology Toxicology, FDA From Antibodies to Synthetic Proteins Presented by: Sachdev Sidhu, Professor, Donnelly Centre, University of Toronto Lessons…

The Bay Area Pharma Market Research Conference is your exclusive entry into the world of pharmaceutical market research with a focus on the West Coast, yet also considering the global context of the pharma industry. It is the PREMIER event where all the industry's experts network and share knowledge all under one roof. This unique opportunity only happens once a year! Industry insiders say the Bay Area marketplace needs a fresh forum with strong industry representation where senior-level biopharma executives can gather in a comfortable environment, gain insight from premier thought leaders, explore the most critical issues, discuss best practices…

Overview: This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability. Why should you Attend: This webinar will help you understand in detail the application of FDA's 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. Areas Covered in the Session: System Risk Assessment GAMP 5 "V"Model…

Following the success of the CRISPR Congress in Boston and the launch of CRISPR Congress in Berlin, we are now building a CRISPR community on the West Coast for the genetic/gene editing research community in addition to getting into the burgeoning stem cell market The inaugural Precision CRISPR Stem Cell Congress Seattle 12-14 June 2018, founded in partnership with the Allen Institute, will help the large pharma, biotech and academic community overcome efficiency, specificity and delivery challenges to optimise the application of CRISPR gene editing of stem cells. Showcasing cutting edge data from key opinion leaders who are pushing the…

Course "Applied Statistics, with Emphasis on Verification, Validation, Sample Size, and Risk Management, in R&D, Manufacturing, and QA/QC" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: The 2-day seminar explains how to apply statistics to manage risks and verify/validate processes in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows: • ISO standards and FDA/MDD regulations regarding the use of statistics. • Basic vocabulary and concepts, including distributions such as binomial,…

ESS 2018 is committed to excellence as the conference gives everyone working in the area the opportunity to come together to share information and network with colleagues. The programme has been designed as a training platform for Therapists, Nurses, Therapy Assistants, Clinical Engineers, Clinical Technicians, Suppliers, Managers, Healthcare Professionals and Students to participate in the Seating and Assistive technology assessment and provision process. The conference is suitable for foundation, intermediate and advanced levels of knowledge. The acclaimed speakers will travel from around the world, and are leading professionals in the areas of Specialised Seating and Assistive Technology, Occupational Therapy, Physiotherapy…

Product Format: Live Webinar Presenter: Dorothy D. Steed, CCS, CDIP, COC, CPCO, CPUM, CPUR, CPHM, CPMA, ACS-OP, CCS-P, RCC, RMC, CEMC, CPC-I, CFPC, PCS, FCS Conference Date: Tuesday, June 12, 2018 Aired Time: 1:00 pm ET | 12:00 pm CT | 11:00 am MT | 10:00 am PT Length: 60 minutes Price: $197.00 Behavioral health challenges are frequently identified in primary care or emergency center encounters. How does the behavior affect management of medical problems? Join this session, where auditing and training expert Dorothy D. Steed will review multiple types of behavioral health encounters and documentation elements that payers seek…

Changes in the FDA’s regulation of software makes life a lot easier for medical device manufacturers. FDA faced an overwhelming challenge when it started to develop a regulatory program beyond the basic Quality System regulation and the Software Guidance issued in 2002. Congress and FDA have made huge changes in FDA’s legal jurisdiction, and FDA has made dramatic revision of its regulatory program. FDA no longer regulates low risk software, premarket guidance documents must be revised or withdrawn, firms can give themselves 510(k) market clearance rather than FDA, firms can substitute requirement of Reports of Corrections and Removals by participating…

Operating a commercially viable chemical process requires a good chemical synthesis to start with, but is also subject to the interplay of a myriad of important physical phenomena - heat transfer, mass transfer, fluid flow, etc. which are traditionally the realm of the chemical engineer. An understanding of these scale-up phenomena is crucial for the laboratory development of processes that will scale successfully. This course presents an overview of these issues and examines their impact on process operation in the pilot plant and beyond, including scale-up considerations for route selection, raw material charging, reaction steps, workup, crystallization, product isolation, drying,…

Developing safe processes is of paramount importance to any chemical company. Exothermic chemical reactions in batch and semi- batch processes can result in serious injury to people and plant if they get out of control. Results of thermal runaways include violent loss of containment, possibly explosion and the release of flammable or toxic materials to the environment. Employers are bound by Health and Safety legislation to ensure the safety of their employees and those outside their employment who might be affected by their activities. Chemical manufacturers must therefore be aware of all potential dangers in their processes and take steps…