Summary This webinar is designed to to outline the characteristic of an effective work instruction,and Standard operating procedure.The webinar is also designed to help differentiate Work Instructions from Standard operating procedures.Attendees will learn the steps used to write effective work instructions and Standard operating procedures. Details "Attendees will recieve a complimentary e-book of " How to write standard operating procedures and work Instructions", published by the Instructor in 2010.The e-book will be send out to attendees after the webinar. Discount : Get 15 % Discount as a early bird registrations. Use Promo code CGO15 Why should you attend : The…

Why Should You Attend: Selection of best disinfectants, applying right performance parameters and methods to qualify are keys to designing an effective disinfectant validation program to meet FDA, Irish Medical Board, MHRA, and EMEA scrutiny. This webinar provides guidance on industry trends, regulatory feedback, and keys to design for an effective validation program. Current 483's, Warning Letters, and Field Experiences will be conveyed that allow end users to determine that best methods to validate sanitizers, disinfectants, and sporicides against their isolates. Common pitfalls and issues with validation testing and test methods will be discussed in an effort to improve the…

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.…

On behalf of the organizing committee, I cordially welcome you to join "BIT’s 2nd Annual World Congress of Catalytic Asymmetric Synthesis (WCCAS-2011) ", which will be held during August 9-11, 2011 in Beijing, China, with a theme of " Toward Low Carbon Green Chemistry ". WCCAS is a focused event on Catalytic Asymmetric Synthesis, it aims to stimulate interactions among academia, industry and researchers in this field; to exchange up-to-the-minutes information and promote their novel technologies. WCCAS is expected to greatly contribute to the promotion of new concepts for the development of efficient methodologies for catalytic asymmetric synthesis and its…

Why Should You Attend: This webinar will provide valuable information on the regulations of the USA, Canada and the EU as they apply to your management of vendors of services and materials and how the agencies are changing their interpretations. We will examine successful workable processes that are compliant with the regulations and yet efficient from a business perspective, and show how companies meet these stringent regulations. Areas Covered in the Seminar: - What the elements of a vendor qualification program are? - What regulations govern the vendor qualification program? - How the agencies are reinterpreting the regulations and enforcing…

Understand the steps of a extractables / leachables study, get knowledge about the gap analysis of literature sources and how to design an efficient E/L study. Why Should You Attend: The FDA industry guidance for container-closure systems for packaging human drugs and biologics requires the testing of container closure components for extractable leachable for all injectibles. Since biologics products are particularly sensitive to leachable there has been increased scrutiny of extractable and leachable associated with biotechnology drug products. The time and resources required for testing for extractable/leachable can be conserved by appropriately planning the study. This interactive webinar will provide…

In this Bioanalytical methods validation understand the Clear, Consistent and compliant approaches for instrumental, ligand binding, and cell based methods. This webinar will discuss the best practices of Bioanalytical method validation, including components of a validation, how to include critical reagents comparison, selectivity experiments, assessment of stability. Concept of plate and experiment separation. Importance of communication between the development and the validation labs, accuracy of transfer documents (SOPs). Predicate rules, support of clinical and non clinical sample analysis. Understand - Is validation a regulated activity? When to pull the trigger for validation? Is a stable label internal standard always the…

4th International e-Conference on Agricultural Biosciences-2011. Scientists in all spheres of biological sciences related to Agriculture and the Environment are warmly invited to participate in the forthcoming 4th International e-Conference on Agricultural Biosciences (IeCAB 2011), to be held from August 1-15, 2011. Register by sending an email to secretary@e-conference.elewa.org or publications.biosciences@gmail.com. After registering send materials to be exhibited either as MS Word abstract, Poster, PowerPoint presentation (max 15 slides) or a short video (10 min). A scientist can exhibit upto three (3) presentations for the e-conference, which will be published as three separate papers. Participants are further encouraged to develop…

Why Should You Attend: In July 2010, the FDA announced that it will conduct a series of inspections related to 21 CFR Part 11. The FDA made it very clear that Part 11 is in effect and will be enforced according to original Part 11 and the Guidance from 2003. While this guidance leaves a lot of room for interpretation and uncertainty, an excellent way to find out FDA's expectations is to learn from recent Part 11 related warning letters. From 2007-2011, there have already been more than 30 warning letters with deviations related to computer system validation and Part…

Why Should You Attend: This highly interactive course will include detailed discussions of current regulatory expectations and is therefore suitable for individuals new to the pharmaceutical industry and also serves as a refresher course for others. This webinar will provide the attendee with a step-by-step foundation for determining product shelf life through stability testing. This comprehensive training course outlines the issues and guidelines surrounding FDA, ICH and increasing important Global regulatory requirements. In the second section, the course will address a all the steps in a stability program starting from designing an effective stability program to preparing a Stability Report…

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…

Why Should You Attend: Conducting clinical trials and collecting accurate and viable data is an essential and costly component of the drug development paradigm. Sponsors, CROs and 3rd party vendors are held accountable to ensure the most efficient and effective delivery of high quality data from each and every trial that they complete. In the larger research community, clinical trials may have subject matter experts, Although the pharma industry is moving forward with electronic data transfer for many aspects of a trial, how those data are collected, reviewed, archived and retrieved is an arduous task for clinical teams. With collaborative…

This conference comes at a pivotal time for the life science industry. The benefits of performing trials in emerging markets such as Latin America, Asia Pacific Region and Eastern Europe include lowering overall cost of trial, faster timelines, and increased patient populations. As globalization becomes the industry norm, and more trials require naïve patient populations, trials in the ‘pharmerging’ countries will continue to flourish. Continuing our renown clinical trials series, our 6th Annual Clinical Research in Emerging Countries Conference will continue to deliver what it has done best in the past, case study presentations from leading experts from the top…

marcus evans invites you to attend our 4th Annual Product & Pipeline Enhancement for Generics Conference, geared towards Heads, Managing Directors, SVP’s, VP’s, and Directors. Hear from leading executives within the industry on how to improve product pipelines, while investigating the latest developments in patent litigation and FDA requirements. Click Here for Conference Agenda: http://bit.ly/kXvGft Our program is packed with speakers from companies such as Amneal Pharmaceuticals, Sandoz Inc, Dr. Reddy’s Laboratories Ltd, RanBaxy Inc, and many more! Attending this conference will allow you to: ·Understand the current generic market to ensure success in portfolio and product management ·Comply with…

Why Should You Attend: All sponsors, CROs, Sites and auditors of Clinical Research who are involved in pharmaceutical or biological development need to possess the knowledge and be efficient in completing successful applications for their studies. Knowing what is expected of you and “getting-it-right” the first time, will allow faster development of innovative products. This 90 minute training course will provide your company the opportunity for comprehensive understanding of the IMPD (Investigational Medicinal Product Dossier) and the structure and content differences between a EU CTA Application and an FDA IND Application. Additionally, this webinar covers many related processes sponsors will…

Why Should You Attend: All sponsors of clinical trials in the US for drug and biologics have to first file an Investigational New Drug (IND) application with the FDA containing extensive information in support of the proposed clinical trial. Each year hundreds of new INDs are submitted to the FDA, about half of which are not cleared to proceed with the planned clinical trial within the 30 day review period mostly due to deficiencies in the information provided in the IND. Failure to submit a satisfactory IND could lead to FDA imposing a clinical hold on the clinical trial in…

Why Should You Attend: This full-day ICH GMP training course will provide your company the opportunity for a comprehensive understanding of ICH GMP and the nuances and differences between the three main ICH triumvirate regions (U.S. EU and Japan). It will cover the key areas of how ICH was established, it's goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or PMDA. Agenda: (All time in EDT): 10:00 am EDT to 12:00 noon (Agenda Sections I – V below) 12:00…

This presentation will convey a robust approach to addressing bacterial spores by covering personnel practices, incoming items into cleanrooms, facility design and conditions, and the products used to address bacterial and mold spores as well as more resistant bacterial spore species. The audience will get a flavor of the current issues in the industry with bacterial spore outbreaks and develop a better understanding of how to prevent outbreaks. The audience will also see sporicidal data and hear industry experiences which will allow them to better address contamination control programs. The presentation will provide troubleshooting skills and experiences for bacterial spore…

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

The Web's Largest Online Social Media in Pharma Conference Maximizing your digital assets and medical communication strategies to gain actionable insights from your patient base This interactive online event will bring together an international panel of thought leaders to discuss and debate the challenges and opportunities social media presents for the pharmaceutical industry – all of this in a convenient online format. During the series of webinars, participants can see who is 'logged in' to the event and initiate a private chat to exchange ideas and contact details. This 100% online event begins July 12 and runs through August 4,…