This is Asia’s first event dedicated to addressing the challenges faced by pharma professionals responsible for strategic sourcing, procurement and outsourcing. A must attend meeting for pharma executives in the business of or considering sourcing from Asia and outsourcing to Asia. It is estimated that China could be the world’s 2nd or 3rd largest pharmaceutical market by 2020 – Does your sourcing strategy give you a piece of the lucrative ‘China-pie’? Why You Must Attend This Year’s Event •The region’s first to market event focusing on the strategic needs of procurement and sourcing professionals specific to the pharma industry •The…

This 90-minute webinar will focus on the critical steps in starting up a new cleanroom operation and releasing it for manufacturing. It includes a case study-based approach to dealing with excursion events and establishing control of the cleanroom after a worst case event. Why Should You Attend:- This webinar will focus on starting up a new cleanroom operation covering from utilities to environmental monitoring. Routine cleaning and disinfection will also be addressed. Addressing contamination and bringing up the cleanroom after a worst case even will be discussed. Cases studies on bringing up the site after a worst case event will…

This webinar will provide an introduction to FDA’s regulation of veterinary regenerative medicine and highlight the regulatory requirements that a biotech company needs to satisfy to commercialize a stem cell or other complex biotech product for animal use in the U.S. Why Should You Attend:- The rapid development of cell-based and related biological therapies for use in veterinary medicine has provided exciting new options for the safe and effective treatment of common veterinary diseases and conditions such as osteoarthritis, tendon strain injuries, suspensory desmitis, congestive heart failure and other commonly diagnosed diseases and injuries. FDA’s Center for Veterinary Medicine (“CVM”)…

This Project Management training for Auditors will help you understand how to apply project management principles to auditing to ensure efficient and effective quality assurance of drug development. Why Should You Attend:- Auditing is essential to ensuring quality assurance of drug development. Each audit has a degree of complexity which needs effective project management. With ever increasing pressures to complete the audit promptly and to the appropriate quality standard, the effective use of project management can provide essential tools and techniques to achieve this. Indeed effective project management can be a key factor to successful completion of efficient auditing. This…

This webinar presents a best practices approach for preparing, characterizing and storing cell banks used for GXP analytical and bioanalytical test methods. It covers critical topics such as timelines for generation of cell banks, equipment, growth conditions, purity, consistency, and stability. Why Should You Attend:- Cell-based assays are routinely used during biopharmaceutical development for the assessment of product potency, the determination of pharmacokinetic and pharmacodynamic profiles and the detection of neutralizing antibodies, among other applications. The accuracy and reliability of test results generated by these methods is critically dependent upon the production of controlled and consistent cell banks. Learning Objectives:-…

The accidental release of toxic, reactive, or flammable liquids and gases in processes involving highly hazardous chemicals can be catastrophic due to the human, financial and business costs of an incident. The risks, primarily to human capital, but also to plant equipment are enormous and those responsible for Health and Safety are devoted to executing the best practices in maintaining a safety-minded culture and preventing highly critical assets from failing. The marcus evans 3rd Process Safety Management for the Chemical Petrochemical & Refining Industries Conference will generate awareness on the evolution of risk mitigation and safety processes. By attending, delegates…

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 learn how to decrease software implementation times 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. Students see how 21 CFR Part 11, the FDA regulation pertaining to use…

Course Description: This 2-day on-site Course will help you gain a comprehensive understanding of the Regulatory Structure, Clinical Trial Requirements and the Conduct of Running Clinical Research in Japan and South Korea. It will prepare you for the regulatory approval processes, Agency meetings, the complexities of running studies in both countries, the importance of partner selection and the cultural knowledge needed for success. The recent changes made by PMDA and KFDA to be more sponsor-friendly will be reviewed. Real world experiences on actual interactions with the Agencies since these changes, will also be discussed. Who will Benefit: This course will…

Course Description :- All pharmaceutical, biologics, and medical device facilities 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 who should understand the microorganisms in water systems and how best to monitor and control and them, it should be the site’s microbiologists. 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 course is…

Overcoming regulatory and technological hurdles to reap the rewards of China’s biopharma growth Biologic Manufacturing China 2012 is the only event in China that will cover the entire spectrum of biologic manufacturing, from early stage development to scale up manufacturing. This event will gather senior executives who are living and breathing critical challenges for biologic manufacturing to discuss and overcome regulatory and technological challenges to reap the rewards of China’s biopharma growth. Key topics covered include GMP compliance, build in quality, advanced engineering for process development and overcoming challenges throughout scale-up manufacturing. Attend Biologic Manufacturing China 2012 and get to:…

Keynoted by Dr Robert Langer of MIT, this is a strategic level event designed(with two purposes: 1. To present a strategic level event for pharma and biotech business development and external licensing professionals with a thorough overview of the latest drug delivery technologies available along with an update on deals and opportunities to enhance patients, therapies and the life cycle of a drug. 2. To provide drug delivery and specialty pharmas with a platform to present their technologies and get the latest insights from both established pharma and biotechs as well as start up companies on what the delivery and…

Led by Pfizer and Novartis, this groundbreaking conference delivers only case studies that demonstrate either a disruptive or an innovative approach to advancing clinical trials. Mobile Clinical Trials, Virtual Trials, Open Source Clinical Development are just a few examples of case studies featured.  This conference is designed to be engaging in a highly informative format, similar to the style of TED events. Each session will deliver a clear set of objectives, summary and key take-aways around:     1.Challenges and opportunities in clinical development/trials     2.Innovations in science applied to clinical development/trials     3.Innovations in technology applied to clinical development/trials    …

This strategic level event is focused on how to execute global trials to produce higher quality data at less cost. Led by Purdue Pharma and BMS, key topics include Infrastructure, non-traditional markets, risk management, ethics/corporate responsibility and outsourcing. International regulations and where the clinical, commercial and therapeutic opportunities are outside the US is covered. 10% discount for World Conference Calendar Readers with code WCCGCT

This webinar on Risk Evaluation and Mitigation Strategy (REMS) will help you understand how to adhere to REMS policy, its implementation and submission requirements. It will discuss FDA's current thinking on REMS, how it reduces the REMS obligations for sponsors, and how the agency's requirements and procedures in this area are evolving. Why Should You Attend:- Risk Evaluation and Mitigation Strategy (REMS) continues to be a critical part of the FDA’s focussed efforts to increase safety of marketed products (drug or biological). As such they are enforceable by civil monetary penalties of up to $250,000 per violation that can continue…

This 2-hr webinar will review the FDA and FTC regulations for promoting and advertising dietary supplements, walk you through real-life case studies, help you address compliance, and tell you how to respond to an FDA enforcement action. Why Should You Attend:- FDA and FTC routinely initiate enforcement actions, including Untitled Letters, Warning Letters, Recalls, etc., against dietary supplement makers who misbrand their products by violating FDA advertising and promotion regulations, e.g., by claiming the product can treat, cure, prevent, mitigate or diagnose disease. Sometimes the Department of Justice gets involved and prosecutes firms on behalf of these agencies for violations.…

This webinar will provide a comprehensive overview of FDA regulations for cosmetic products. It will help you understand how to be compliant in manufacturing, labeling and advertising of cosmetic products, and thereby ensure successful FDA and state inspections. Why Should You Attend:- Being unaware of the regulations that apply to the cosmetics industry is a tenuous position to be in. Should your products come under scrutiny, will you be able to pass FDA and state inspections or will your business be in jeopardy? This presentation will help the management and staff of cosmetics companies to understand the regulations and how…

This 90-minute training on statistics used in pharmaceutical quality control will cover statistical interpretation related to quality control test results and process indicators in the pharmaceutical industry. Why Should You Attend:- Quality control tests in pharmaceutical industry carries a burden on its own, as these tests are usually complicated, time consuming and expensive, and in many cases wrong interpretation of test results lead to disastrous situations. Any QC test is not considered successful until the resulting data are analyzed statistically and are complied within specifications limits. Wrong interpretation of the tests results can cost the company since it can end…

This webinar will cover techniques and process that can help you assure reliability and consistent quality from your suppliers or contract manufacturers. You will learn how to monitor your supplier and ensure they meet FDA's quality requirements. Why Should You Attend:- No matter where a product is manufactured, quality is the responsibility of the organization whose name appears on the label. If you hire a contract manufacturer to make products that will carry your label and your name, the responsibility for the quality of that product is yours. There are many things that you can do to assure quality and…

This webinar on validating legacy computer systems will give a good understanding of FDA and EU regulatory requirements for validation (retrospective validation) and provide tools for effective implementation. Why Should You Attend:- When existing or legacy computer systems are used in FDA or equivalent international environments they should be validated, a process sometimes called retrospective validation. While the industry is very well familiar with the validation of new systems, there are many questions about existing or legacy systems. This web seminar will give a good understanding on the regulatory requirements, and it will have recommendations and provide tools for effective…

This Clinical trial auditing training will provide an understanding of how to conduct compliant and successful clinical trials by defining FDA clinical trial audit procedures, audit program, audit planning and audit preparation. Why Should You Attend:- The field of GCP has rapidly evolved over the last few years and the requirements are getting tougher. Many companies find themselves unprepared for a clinical trial audit, either at a clinical site or their headquarters. This course will help you to prepare early and help to prevent surprises when being audited. Learn to identify risks and handle them to build a more compliant…