World Conference Calendar

35105 Conferences

Physical and Life Sciencesrss


AsiaTIDES Oligonucleotides and Peptide®

AsiaTIDES Oligonucleotides and Peptide®

Location: , Japan
Category: Physical and Life Sciences
Start Date: 03-02-2011 Last Day: 03-04-2011
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…
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…
How to withstand an FDA audit : A primer for clinical sites

How to withstand an FDA audit : A primer for clinical sites

Location: , United States
Category: Physical and Life Sciences
Start Date: 02-10-2011
This FDA Audit webinar training will discuss the types of audit and what are the activities to be done before, during and after FDA audit to pass it successfully and how to increase credibility for your company. Why Should You Attend: If your company is marketing a product or service that is regulated by the FDA, you should be prepared for an FDA audit. If you have never been audited by the FDA or if you were last audited 4-6 years ago, if any product or service you offer has been in the news – positive or negative, or if…
Designing effective and efficient Extractables/leachables studies

Designing effective and efficient Extractables/leachables studies

Location: , United States
Category: Physical and Life Sciences
Start Date: 08-04-2011 Last Day: 08-04-2011
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…
Bioanalytical Methods Validation - Webinar By ComplianceOnline

Bioanalytical Methods Validation - Webinar By ComplianceOnline

Location: , United States
Category: Physical and Life Sciences
Start Date: 08-02-2011 Last Day: 08-02-2011
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…
Particulates in Biological products - Biotech Webinar By ComplianceOnline

Particulates in Biological products - Biotech Webinar By ComplianceOnline

Location: , United States
Category: Physical and Life Sciences
Start Date: 02-18-2011
Understand FDA expectation for reporting for sub-visible particulate testing in biologics injectibles and various methods used for characterization of the sub-visible particles. Why Should You Attend: Particulates in Biologics injectibles can arise from the aggregation of the protein product. It has been suggested that the aggregated material presents a safety concern because it increases the possibility of formation of anti drug antibodies. The FDA has therefore requested BLA sponsors to present sub-visible particulate data at the clinical and commercial stage and has identified the 0.2 - 10 micron as a range where there is a lack of suitable techniques for…
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…
21 CFR Part 212: Quality Systems to Ensure cGMP Compliance

21 CFR Part 212: Quality Systems to Ensure cGMP Compliance

Location: , United States
Category: Physical and Life Sciences
Start Date: 02-11-2011
Learn the new GMP regulation 21 CFR 212, what are the compliance requirements for PET drug manufacturers, how to establish a quality system to ensure cGMP compliance. Why Should You Attend: The new GMP regulation, 21 CFR 212 “Good Manufacturing Practices for Positron Emission Tomography Drugs”, becomes effective on 11 December 2011 and will require all manufacturers of Positron Emission Tomography (PET) drugs to submit either a new drug application (NDA) or abbreviated new drug application (ANDA) for any PET drug product marketed for clinical use in the United States. For PET drugs intended for clinical investigations only or for…
Understanding and Implementing FDA’S 21 CFR Part 11

Understanding and Implementing FDA’S 21 CFR Part 11

Location: , United States
Category: Physical and Life Sciences
Start Date: 02-08-2011
Understand 21 CFR Part 11 requirements and get a guidance how implement it in a cost effective way. Briefing about part 11 inspections. Why Should You Attend: In 1997 the US FDA issued a regulation that provides criteria for acceptance by the FDA of electronic records, electronic signatures and handwritten signatures. The rule applies to all industry segments regulated by the FDA that includes Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP). Even the rule is more than 10 years old there still many questions related to the scope and real requirements of Part…
World Fisheries Congress 2012

World Fisheries Congress 2012

Location: , United Kingdom
Category: Physical and Life Sciences
Start Date: 05-07-2012 Last Day: 05-11-2012 Deadline for abstracts: 11-02-2011
The World Council of Fisheries Societies is a non-profit, nongovernmental organisation that currently includes 12 scientific and professional fisheries societies and affiliated organisations world wide. The main aim of the Council is to promote international cooperation in fisheries science, conservation and management by encouraging and promoting sustainable management practices, excellence in fisheries research and the wise use of fishery resources. One important way in which the Council seeks to achieve these ends is through the organisation of a major World Fisheries Congress every 4 years. The Congress has hosted 5 highly successful meetings, the most recent being the 5th in…
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…
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…
21 CFR Part 11 and Annex 11 Compliance; specifics needed to eliminate 483s

21 CFR Part 11 and Annex 11 Compliance; specifics needed to eliminate 483s

Location: , United States
Category: Physical and Life Sciences
Start Date: 07-24-2012 Last Day: 07-24-2012
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…
Reduce COTS Software Validation using the risk-based approach

Reduce COTS Software Validation using the risk-based approach

Location: , United States
Category: Physical and Life Sciences
Start Date: 10-26-2011 Last Day: 10-26-2011
Understand 10 step Risk based approach to validation, explore methods to decrease resource requirements and make documentation more manageable and understandable. Why Should You Attend: This session explores proven techniques that reduce validation project time, often to one-third. Learn efficient documentation strategies for computer system validation and how to increase overall system productivity. The 10-step risk-based validation approach is detailed so that the specific documents for a validation project are understood. Explore methods to decrease resource requirements, and make documentation more manageable and understandable. This often results in a savings of two-thirds the cost. Additionally, this course will help companies…
Excel Spreadsheets; develop and validate for 21 CFR Part 11 compliance

Excel Spreadsheets; develop and validate for 21 CFR Part 11 compliance

Location: , United States
Category: Physical and Life Sciences
Start Date: 08-17-2011 Last Day: 08-17-2011
How to Use excel spreadsheet for GXP data and reduce validation cost and time. Why Should You Attend: Learn how to create an Excel spreadsheet application that is GxP compliant. Understand how to validate your application with minimal documentation. Follow the step-by-step instructions as we configure Excel for audit trails, security features, and data entry verification. This session includes an interactive workshop so you can learn techniques that are important to you. Bring your laptop and use Excel for your own needs. Areas Covered in the Seminar: Avoid 483s and Warning Letters. Become compliance when using Excel spreadsheets for GxP…
Eliminate the Confusion –Annex 13 GMP guide

Eliminate the Confusion –Annex 13 GMP guide

Location: , United States
Category: Physical and Life Sciences
Start Date: 01-21-2011
This GMP webinar will help you understand the compliance requirements concerning Annex 13 of the GMP guide. The session will review the guideline to cover the key areas of compliance including: The role of the "Qualified Person", Packaging, labeling, reconciliations that should take place for each product and each production stage, and Comparator product requirements etc. Areas Covered in the Seminar: Review the role of the "Qualified Person" who must have access to the Product Specification File as the basis for assessment of the suitability for release and certification of a particular batch. Packaging instructions requires expressly with a view…
How to transfer QC procedures for commercial products in pharma industry - ICH and USP guidelines

How to transfer QC procedures for commercial products in pharma industry - ICH and USP guidelines

Location: , United States
Category: Physical and Life Sciences
Start Date: 02-03-2011
Once a product goes commercial, measuring the quality, safety, and efficacy attributes of the drug substance and the drug product is crucial. There are well-established ICH guidelines for the validation requirements of typical analytical procedures. In contrast, the requirements for a technical transfer of an analytical procedure from one site to another or within a site to a separate facility are often debated. It is critical that a robust transfer program be put into place in order to head off issues. Unearthing issues at the drug development stage, rather than during routine manufacture, will improve the overall success of the…
Full Day Virtual Seminar - Understanding Biofilm and Controlling It in Pharmaceutical Water Systems

Full Day Virtual Seminar - Understanding Biofilm and Controlling It in Pharmaceutical Water Systems

Location: , United States
Category: Physical and Life Sciences
Start Date: 01-27-2011
This interactive one-day course provides a thorough understanding of what makes water systems have microbial problems with proven solutions for microbial control, arguments for the micro lab being the spearhead of contamination investigations, step-by-step instructions for investigating and resolving microbial excursions in water and associated systems, and how to rationally validate the operation and microbial control in a water systems in a manner that will please FDA. In short, if your job brings you in contact with any aspect of water system design, maintenance, trend monitoring, sampling, testing, sanitization, validation, root cause investigation and response to microbial excursions, or regulatory…
Establishing Global Drug Substance and Drug Product Specifications – What the Guidelines Don’t Tell You

Establishing Global Drug Substance and Drug Product Specifications – What the Guidelines Don’t Tell You

Location: , United States
Category: Physical and Life Sciences
Start Date: 01-13-2011
Learn how to establish global drug substance and drug product specifications that are appropriate to the phase of clinical development and market application, and understand the types of data that are needed to support these specifications. This session will provide instruction on knowing what to file with the regulatory agencies and when in order to maximize the success of your drug development program. You will learn how important it is to have a thorough understanding of the critical quality attributes of the drug substance and drug product to not only improve your ability to make meaningful decisions during development, but…
Full day Virtual Seminar - Compliance for 21 CFR Part 11, reducing costs using risk-based computer system validation

Full day Virtual Seminar - Compliance for 21 CFR Part 11, reducing costs using risk-based computer system validation

Location: , United States
Category: Physical and Life Sciences
Start Date: 01-26-2011
In this CSV seminar learn how to reduce validation project time, efficient documentation strategies, enhance system productivity and increase compliance with the New 21 CFR Part 11 regulations and how to use risk management for improving system performance and process improvement. Why Should You Attend: This interactive one-day virtual seminar provides proven techniques for reducing costs associated with implementing, using and maintaining computer systems in regulated environments. Nearly every computerized system utilized in laboratory, clinical, manufacturing and the quality process has to be validated. Learn efficient documentation strategies for computer system validation and how to increase overall system productivity. Explore…

<< Start < Prev 101 102 103 104 105 106 107 108 109 110 Next > End >>

© 2018 World Conference Calendar. All rights reserved.
About WCC | News | FAQs | Links | Terms and Conditions | Privacy | Contact Us