At IBC's 4th Annual BioProcess International™ China event, the goal is to bring China and the rest of the world together to explore the missing gaps in China's development, and to help bring China up-to-speed on critical areas such as cell line engineering, media development, analytical characterization strategies to establish similarity between a biosimilar and its originator drug, as well as design of multi-product facilities and implementation of single-use systems. Bringing together global leaders to provide you with proven scientific and technical strategies and innovations on: •Cell Line Engineering, Cell Culture and Media Development •Analytical Characterization, Comparability and Quality Assessment…

This Spreadsheet validation training explores strategies for recognizing when validation is required, how to achieve compliance and what documentation needs to be generated and maintained. Description Spreadsheets are powerful business tools, and are increasingly used in manufacturing, tracking and quality systems - as well as in generating and interpreting business data. FDA requires spreadsheets to be validated per 21 CFR 210-211, Part 820 and to be compliant to 21 CFR Part 11 in some cases. Areas Covered in the seminar: - Review of current FDA posture towards spreadsheets. - Review the relationship between "validation" and "part 11 compliance". - How…

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 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…

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 GAMP® 5 training/Webinar will discuss on the GAMP® software validation model and the defined process of GAMP® 5 as it applied to FDA software validation. Why Should You Attend: Many companies struggle with understanding what FDA, MHRA, EU and other Ministries of Health want to see regarding software validation.This presentation will review the FDA validation process, the GAMP® software validation model, and the process defined in GAMP® 5 as it applies to FDA software validation. The attendee should leave the presentation confident in their ability to understand and apply the GAMP® 5 process. - FDA inspectors are now being…

ICSFS-16 will focus on recent advances in controlling and characterizing the physical and chemical properties of films and surfaces, with a particular emphasis on materials for electronic, photonic and spintronic applications, in addition to bio-functionalized structures and devices. This meeting will continue the very successful conference series previously held in Tokyo (1978), Washington (1981), Sydney (1984), Hamamatsu (1987), Providence (1989), Paris (1992), Hsinchu (1994), Osaka (1996), Copenhagen (1998), Princeton (2000), Marseille (2002), Hamamatsu (2004), Bariloche (2006), Dublin (2008) and Beijing (2010)

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”)…

Learn FDA requirements for 21 CFR Part 11, understand how to implement with the help of SOPs and case studies. Why Should You Attend: Though FDA's new Part 11 regulation takes quite some time, but inspectors go out and inspect computer systems and e-records for compliance with GMPs and most recent Part11 interpretations. Just in 2007/2010, there have been about 30 Warning Letters related to Part 11 compliance, some with disastrous consequences for inspected companies. It seems that 'enforcement discretion' as stated in the 2003 guidance is not applied any more. Also FDA's computer expert John Murray recommended at a…

The objective of the Sixth International Conference on Environmental Science and Technology will be to provide a major interdisciplinary forum for presenting new approaches from relevant areas of environmental science, to foster integration of the latest developments in scientific research into engineering applications, and to facilitate technology transfer from well-tested ideas into practical products, waste management, remedial processes, and ecosystem restoration. Environmental humanity and sociality such as environmental ethics, environmental law, environmental economy and environmental management are also included in the scope of the conference. Researchers, engineers, site managers, regulatory agents, decision-making officials, consultants, and vendors will all benefit from…

This 90-minute webinar on sampling plans using ANSI/ASQ Z1.9 will explain the methods in Z1.9 and shows how to use it in a more modern setting (using simple statistical calculators). Why Should You Attend: Many companies use attribute sampling plans at incoming, in-process, and final inspection. The common approach uses ANSI/ASQ Z1.4. There is an alternate, however, that may reduce cost. Sampling plans based on ANSI/ASQ Z1.9 can reduce cost by requiring smaller sample sizes. Z1.9 is an effective and efficient method for acceptance sampling. Because it retains the methods required before calculators and spreadsheets, the standard appears overly complex.…

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…

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:-…

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 help you understand the significant differences between qualification and validation of an analytical method, the expectations and requirements of each, and their place in the analytical method lifecycle. Why Should You Attend:- Execution of a method validation is a resource intensive activity, both in terms of manpower, equipment usage, time, and money. The more the process is well defined and understood, the greater the potential for an efficient project. The less the process and its elements are understood, the greater the chance for delays and additional resource expenditures. There is confusion and a lack of guidance over…

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…

This webinar will help you understand how non-IND clinical trials at non-US locations can be used successfully to support an IND/IDE or a marketing approval application. It will cover the critical product specific issues (drugs, biologics, diagnostic kits and medical devices) that need to be addressed when using non-US data for discussions with FDA. Description :- FDA acceptance criteria for non-IND/IDE clinical trials are based on internationally recognized standards of quality, ethics, and practices for human subject protection. An adequately designed non-US study can be used to greatly reduce the time of cost of getting the tested product to the…

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…

This ICH Q10 training /webinar will discuss the evolution and interpretation of the pharmaceutical GMPs as a quality control regulation to the Quality Assurance emphasis of the Pharmaceutical Quality System as defined in ICH Q10. Why should you Attend: Since the release of the Quality System Regulation for medical devices, the FDA has been trying to transition the pharmaceutical industry to a Quality System approach to compliance. The issuance of the Guidance for the Industry: Quality System Approach to Pharmaceutical CGMPS and ICH Q10. Pharmaceutical Quality System has brought new focus to Quality Systems in the pharmaceutical industry. This seminar…