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31707 Conferences

Physical and Life Sciencesrss


A Comparison of ICH Q-10 Quality System and the FDAs Quality Systems Approach (QSA) to the Pharmaceutical cGMPs

A Comparison of ICH Q-10 Quality System and the FDAs Quality Systems Approach (QSA) to the Pharmaceutical cGMPs

Location: , United States
Category: Physical and Life Sciences
Start Date: 03-11-2011
This 4 hr webinar on ICH Q-10 Quality System and the FDAs 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…
Understanding and Implementing USP

Understanding and Implementing USP

Location: , United States
Category: Physical and Life Sciences
Start Date: 03-22-2011
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…
An Introduction to FDA's Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products

An Introduction to FDA's Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products

Location: , United States
Category: Physical and Life Sciences
Start Date: 03-22-2011
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 products 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%…
Protein and Peptide Conference - PepCon-2011

Protein and Peptide Conference - PepCon-2011

Location: , China
Category: Physical and Life Sciences
Start Date: 03-23-2011 Last Day: 03-25-2011
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…
Electronic Records: Effective Approaches that Reduce Costs

Electronic Records: Effective Approaches that Reduce Costs

Location: , United States
Category: Physical and Life Sciences
Start Date: 03-24-2011 Last Day: 03-25-2011
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…
Off-Label Compliance

Off-Label Compliance

Location: , United States
Category: Physical and Life Sciences
Start Date: 03-28-2011 Last Day: 03-29-2011
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…
QbD Approach to Analytical Method Lifecycle: Design, Development, Validation and Transfer

QbD Approach to Analytical Method Lifecycle: Design, Development, Validation and Transfer

Location: , United States
Category: Physical and Life Sciences
Start Date: 03-29-2011
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…
A Comprehensive View of Content for an Approvable CMC Section

A Comprehensive View of Content for an Approvable CMC Section

Location: , United States
Category: Physical and Life Sciences
Start Date: 03-29-2011
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…
GLP or GMP: A Comparison in Terms and Application for Drugs and Biologics

GLP or GMP: A Comparison in Terms and Application for Drugs and Biologics

Location: , United States
Category: Physical and Life Sciences
Start Date: 03-30-2011
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.…
Vendor/Supplier/CRO Compliance  Lessons Learned & Rules to Live By

Vendor/Supplier/CRO Compliance Lessons Learned & Rules to Live By

Location: , United States
Category: Physical and Life Sciences
Start Date: 04-07-2011 Last Day: 04-07-2011
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.
Why and How - Verification of Compendial Methods - USP

Why and How - Verification of Compendial Methods - USP

Location: , United States
Category: Physical and Life Sciences
Start Date: 04-08-2011 Last Day: 04-08-2011
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…
6th International China Pharmaceutical R&D Summit

6th International China Pharmaceutical R&D Summit

Location: , China
Category: Physical and Life Sciences
Start Date: 04-11-2011 Last Day: 04-13-2011
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…
Residual Solvents: Practical Strategies for Compliance

Residual Solvents: Practical Strategies for Compliance

Location: , United States
Category: Physical and Life Sciences
Start Date: 04-12-2011
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…
Physicians and NPPs: Avoiding Medicaid and Medicare Fraud and Abuse

Physicians and NPPs: Avoiding Medicaid and Medicare Fraud and Abuse

Location: , United States
Category: Physical and Life Sciences
Start Date: 04-19-2011 Last Day: 04-19-2011
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…
BIT Life Sciences 2nd World DNA and Genome Day

BIT Life Sciences 2nd World DNA and Genome Day

Location: , China
Category: Physical and Life Sciences
Start Date: 04-25-2011 Last Day: 04-30-2011
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…
Dissolution Instrument Qualification

Dissolution Instrument Qualification

Location: , United States
Category: Physical and Life Sciences
Start Date: 04-26-2011
This webinar will provide participants with an understanding of USP and FDA requirements for dissolution instrument qualification and provide strategies that will enhance success and minimize resource requirements. Why Should You Attend: Qualification and calibration of analytical instruments is a key component of CGMPs in each of the major regions. Calibration failures for dissolution instruments have plagued the industry for many years. This is not unexpected, since the dissolution test is more challenging than many other analytical tests, since it involves chemical and physical factors that are changing in a very rapid timeframe. In the last several years there has…
Avoiding 'Failure to Investigate' - Observations by Conducting Effective Investigations

Avoiding 'Failure to Investigate' - Observations by Conducting Effective Investigations

Location: , United States
Category: Physical and Life Sciences
Start Date: 04-28-2011
This webinar will focus on the key attributes of an effective cGMP investigation, the role of management, employing quality control tools, CAPA effectiveness checks and Warning Letters associated with cGMP compliance. Attend this training and learn how you can avoid Failure to Investigate" Observations by FDA. This webinar will discuss five key attributes of an effective cGMP investigation, the role of management, employing quality control tools, CAPA effectiveness checks and Warning Letters associated with cGMP compliance. NOTE: Use This Promocode ( 117660 ) To Get 10% Discount.
Develop appropriate validation activities to meet to meet U.S. FDA, ICH Q9 and ISO 14971

Develop appropriate validation activities to meet to meet U.S. FDA, ICH Q9 and ISO 14971

Location: , United States
Category: Physical and Life Sciences
Start Date: 04-28-2011 Last Day: 04-28-2011
Why Should You Attend: A Validation Plan is the backbone of a company's validation activities and provides a clear and concise plan for complying with 21 CFR Part 11. The categorization of software determines the validation activities to be followed. In this webinar, we will discuss the five categories of software and also focus on the activities required for validation. Examples of each category and activities will be discussed and frequently asked questions will be answered (e.g. Do I have to validate an Excel Spreadsheet?) The components of the Validation Plan will be identified and activities describing timing and roles/responsibilities…
A Comparison of ICH Q-10 Quality System and the FDAs Quality Systems Approach (QSA) to the Pharmaceutical cGMPs

A Comparison of ICH Q-10 Quality System and the FDAs Quality Systems Approach (QSA) to the Pharmaceutical cGMPs

Location: , United States
Category: Physical and Life Sciences
Start Date: 05-05-2011 Last Day: 05-05-2011
Why Should You Attend: The ICH and FDA guidance documents on Pharmaceutical cGMPs stress the importance of management's responsibility to meet customer needs by encompassing quality improvement through quality by design (QbD), risk management, process control, and user feedback and experience. This new paradigm forces industry leaders as well as the FDA to rethink their roles in this dynamic regulatory-business environment. Here, quality principles trump the dictates of compliance. If your company fails to respond to this new calling, it may not be able to compete effectively in the marketplace. These quality concepts are based on well-known and tested quality…
Residual Moisture Testing - Proven Techniques

Residual Moisture Testing - Proven Techniques

Location: , United States
Category: Physical and Life Sciences
Start Date: 05-10-2011 Last Day: 05-10-2011
Why Should You Attend: Monitoring and controlling residual moisture in powders, lyophilized solids, foods, etc can be a critical factor in achieving and maintaining quality products throughout their expected shelf life. Improper levels of moisture in products can result in poor powder flow properties, spoilage, polymorph changes, changes in compaction properties, microorganism growth promotion, higher degradation kinetics, and in the case of freeze-dried products, loss of physical structure and changes in reconstitution properties. There are several methods typically employed to determine residual moisture, and the choice of method will be based on the sample tested, the level of residual moisture…

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