This 21 CFR Part 11 compliance training will guide you through the concept of part 11 and explanation of its 3 primary areas SOPs, Product features and Validation (10 step risk based approach). Why Should You Attend: This webinar describes exactly what is required to be 21 CFR Part 11 compliant. It takes the concepts of Part 11 and expands them into specific things to do in all three primary areas: SOPs, product features, and validation. All required IT SOPs are described. Product features based on the current industry standards are explained in detail. The 10-step risk-based validation approach is…

IBC’s 3rd Annual AsiaTIDES conference is the only event in Japan that gives you the leading research and manufacturing knowledge to fill your pipeline and expand your portfolio. Top pharmaceutical industry experts from around the world will be in attendance to share their experiences and lessons learned. Conference Sessions: •Plenary Session: Keynote Presentations addressing Drug Delivery Challenges and Solutions •Dedicated, Focused Mini Session on microRNA •Oligonucleotides: Updates on Candidates in Preclinical and Clinical Development •Peptides: Updates on Candidates in Preclinical and Clinical Development •Manufacturing and Analytical Development for Peptides and Oligos •Formulation and Delivery of Peptides and Oligos •Business Considerations…

This webinar on Contamination Control will discuss, how the micro lab can be more effectively utilized to prevent or head off microbial contamination issues as well as effectively resolve problems like recurring micro failures, investigations, and ineffective CAPAs. Areas Covered in the Seminar: - Why the microbiology lab must lead in contamination control. . Lab personnel have microbiological knowledge and expertise; QA usually doesn't . Lab uses tools and techniques able to assess contamination and sources . Lab uses appropriate controls to detect and prevent testing problems - Routine contamination evaluation activities. . RM and Product testing . Environmental monitoring…

This webinar on SOPs will instruct you in creating, managing and implementing adequate SOPs that can impress even the FDA inspectors. Why Should You Attend: Formal and written Standard Operating Procedures (SOPs) are the keystone of good operations. SOPs create an important evidence and documentation for the regulatory compliance status of an organization and are one of the first things auditors wants to review when inspecting a site. Almost every deficiency identified in FDA’s 483s and Warning Letters can be traced back to deficiencies in SOPs at the given organization. SOPs are often poorly written, communicated, monitored and enforced. Attend…

This 4 hr webinar on ICH Q-10 Quality System and the FDA’s Quality Systems Approach (QSA) to the Pharmaceutical cGMPs will discuss and analyze in detail the purpose, scope, objectives, and content of these guidances. Why Should You Attend: The QSA to Pharmaceutical cGMPs and ICH-Q10 are guidance documents that stress the importance of management's responsibilities to meet customer needs by encompassing quality improvement through quality by design QbD), risk management, process control, and user feedback and experience. This 4 hour course will provide the attendees with the knowledge and insight required to understand and apply the principles and concepts…

This Analytical Instrument Qualification training will guide you through Understanding of draft for analytical instrument qualification - Essential steps and recommendations for firmware and software validation. Why Should You Attend: Analytical instruments should be qualified to demonstrate suitability for the intended use. Companies are unsure on what exactly to qualify or re-qualify, test and document. The main reason is that unlike for analytical methods there was no clear standard with details for equipment qualification. This has changed. The USP has developed a chapter that provides a framework for analytical instrument qualification (AIQ). This USP webinar will give a good understanding…

This webinar will review FDA's regulatory oversight of stem cell-based products when used in humans and analyze its potential impact on the industry in the future. Learn FDA's criteria for marketing and promotion of stem cell-based products for therapeutic application. This presentation will provide participants with an overview of the HCT/P regulations, an understanding of the criteria that FDA uses to determine a product’s regulatory status for marketing and sale; and a discussion of some of the risks associated with commercializing an HCT/P such as a stem cell-based product today. NOTE: Use This Promocode ( 117660 ) To Get 10%…

Dear Friends and Colleagues, BIT Life Sciences is proud to announce that PepCon-2011 will be held from March 23-25, 2011 in Beijing, China. This international event will focus on the foremost research in protein and peptide science with the theme “New Leaders in Protein and Peptide Science.” On behalf of the organizing committee, we cordially invite you to attend this conference to discuss exciting new ideas and achievements in this field. This conference will be an outstanding experience, both scientifically and socially. Beijing is a great place to congregate with old colleagues and new friends to share the most important…

Course Description: Nearly every computerized system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated. Finding efficiencies without weakening the quality position is essential. This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Attendees will learn how to decrease software implementation time and lower costs using a 10-step risk-based approach to computer system validation. The instructor addresses the latest computer system industry standards for data security, data transfer, and audit trails. Attendees will see how 21 CFR Part 11, the FDA regulation…

This cGMP training will helps you in understanding systematic plan of evaluating cGMP applicable to the IND product cycle, the regulatory mandates (FDA, ICH, CHMP and the EU medicine agency), risk-management strategy and potential consequences for failures in inadequate assessment, and case studies of infractions. Why Should You Attend: cGMP guide lines were formulated for the purpose of regulating large-scale manufacturing and commercial drug products. But it is amended in 21 CFR Part 210 for applicability to small-scale laboratory production of exploratory and investigational drug and biologic products. The amended GMP guide lines are a component of the FDA’s “Product…

Attendees will learn how to minimize risk in off-label discussions and ensure that doctors are properly educated on products. In addition, attendees will learn how to strike a balance between increased sales revenue, increased development time and expanding indications; which is a lengthy and costly process. They will hear about successful compliance plans, effective business practices, and winning litigation tactics from leading in-house counsel, compliance and regulatory officers, and expert attorneys who represent the pharmaceutical and device industries. Finally, attendees will walk away with a better understanding of how to comply with the FDA and prevent off label usage lawsuits…

This webinar on using the QbD approach is designed to provide participants with a lifecycle approach to developing and validating analytical methods and comply with compendial requirements. Why Should You Attend: Analytical methods play a key role in assuring that drug substances and drug products conform to their specifications. Demonstrating that these methods consistently perform appropriately for their intended purpose can be both challenging and resource intensive. By using a pro-active, quality-by-design (QbD) approach, it is possible to design better methods, understand the strengths, weaknesses and capabilities of those method and to perform validation exercises in a scientifically rational way…

Attend this webinar to learn specifically what information is required in sterility assurance documentation and how to present it in CTD format. You will understand differences in content for terminal sterilization versus aseptic processes. Areas Covered in the Seminar: Global regulatory guidance and other relevant sources for sterility assurance. Recent changes in regulatory guidance. Sterility assurance content for marketing applications. Differences in content for terminal sterilization versus aseptic processes. Expectations for requalification of sterile processes. Use of parametric release in lieu of sterility testing at release. Use of container closure integrity in lieu of sterility testing on stability. Validation documentation…

Why Should You Attend: In this seminar, the application of the terms GLP and GMP will be explored, as there is often confusion in their application during development. This seminar will define the terms and their application in the development environment. During product development within an organization that has yet to commercialize a product, the use of the terms GLP and GMP are often confused and may be used incorrectly. Doing so can result in reducing credibility by regulatory health authorities. The objective of this seminar is to define the terms, how they are. Areas Covered in the Seminar: Nomenclature.…

Why Should You Attend: The pharmaceutical business is increasingly relying on Vendors, Suppliers and Contract Research Organizations (third parties) to perform complex and critical process on their behalf. Third party vendors can streamline the complex process of taking products from laboratory through FDA approval and ultimately to market. Collaboration with third-party vendors create opportunities for reducing costs, increasing R&D productivity and allow the Sponsor Organization to focus on growing other business areas. NOTE: Use This Promocode ( 117660 ) To Get 10% Discount.

This verification of Compendial methods webinar training will discuss the requirements of USP , what are FDA expectations related to method verification. Areas Covered in the Seminar: - FDA 483s related to method verification. - Requirements of USP , 'Verification of Compendial Methods'. - What are the current FDA expectations related to method verification. - FDA 483s related to method verification. - Requirements of USP , 'Verification of Compendial Methods'. - What are the factors which impact method performance under actual condition of use? - How compliance to USP and investment risk. Who Will Benefit: This course is intended to…

IBC-BayHelix China Pharmaceutical R&D Summit 2011 announce a never-before line-up of over 80 speakers from international pharma, MNCs in China, and domestic Chinese pharma/biotech will be sharing their expert opinions and experiences on transformation and innovation in China, clinical challenges, regulatory updates, NCE discovery efforts, preclinical partnerships, biosimilars development and more. Enhanced Format – New Content – 3 Focused Conferences : Clinical & Regulatory Summit Discovery to Preclinical Development & Partnerships Biologics & Biosimilars Registration for the event includes access to all 3 conference sessions as well as the opportunity to attend the shared sessions and networking breaks to meet…

This webinar on residual solvents will provide you with practical strategies for complying with regulatory requirements for residual solvents while minimizing resource requirements. Why Should You Attend: Compliance with compendial standards for residual solvents is required for all drug products provided in the United States, and similar requirements exist in all the major markets of the world. Since every product is unique, and since the requirements refer to over 50 different solvents, achieving compliance can be very challenging. Many, many firms have received incomplete or warning letters from the FDA as a result of failure to adequately address the reporting…

Why Should You Attend: Almost all physicians and other practitioners in the practice of clinical medicine in the United States will treat some Federal health care program beneficiaries at some point in their careers. Violating the fraud and abuse laws can result in criminal penalties; civil fines; exclusion from the Federal health care programs, which include Medicare and Medicaid; and even loss of your medical license by your State Medical Board. This presentation summarizes the five main Federal fraud and abuse laws (the False Claims Act, the Anti-Kickback Statute, the Stark Law, the Exclusion Statute, and the Civil Monetary Penalties…

Dear Colleagues and Friends, On behalf of the organizing committee, we cordially invite you to join the 2nd World DNA and Genome Day 2011 (WDD-2011), with a theme of “Reopen Bio-Gateway in Green Economy Era”, which will be held during April 25-30, 2011 at Dalian World Exposition Center, China. WDD-2011 is expected to bring together bioscientists, industrial leaders and decision makers from all over the world in a great range of fields to celebrate the recent breaking researches through cluster conferences, expositions, excellent lectures, tech tours and training programs. WDD-2011 consists of six cluster conferences: -2nd World DNA and Genome…