World Conference Calendar

33622 Conferences

Physical and Life Sciencesrss


Critical Role of Quality Audit in GxP Compliance & Improvement

Critical Role of Quality Audit in GxP Compliance & Improvement

Location: , United States
Category: Physical and Life Sciences
Start Date: 09-29-2010 Last Day: 09-29-2010
This Webinar will address the key elements on being an effective auditor for your company covering the different types of audits, what do audits measure and how are audit results measured and certainly why perform audits to begin with. Areas Covered in the seminar: . Understand that audit preparation is critical and how to generate the audit plan. . Learn the different type of audits and how to prepare, execute and close out the audit. . Selecting your auditor or audit team and knowing the source of authority for conducting the audits. . Development of checklists and using data collection…
Stability Program to support Shipping and Distribution of Drug Products - Pharma Webinar By ComplianceOnline

Stability Program to support Shipping and Distribution of Drug Products - Pharma Webinar By ComplianceOnline

Location: , United States
Category: Physical and Life Sciences
Start Date: 02-17-2011 Last Day: 02-17-2011
Learn the stability studies which need to be done to support shipping and distribution of drugs. Why Should You Attend: Drug Product must maintain its identity, strength, quality and purity throughout its expiration. Physical, chemical and biological data are influenced by various environmental factors such as temperature, humidity and light. In current manufacturing environment, products can be shipped and distributed across different climatic zones. Seasonal changes as well as types of transportation can greatly affect the supply chain of the products. This webinar will outline stability studies to support shipping and distribution of drug products. Upon completion of this session,…
The role of Analytical Program to Support Drug Development Process

The role of Analytical Program to Support Drug Development Process

Location: , United States
Category: Physical and Life Sciences
Start Date: 09-14-2010 Last Day: 09-14-2010
This drug development process training Webinar will give an overview of drug development process, the regulatory requirements and the analytical technology used for pharmaceutical analysis supporting R & D. Areas Covered in the Seminar : . Current Drug Development Process. . Regulatory Submissions in Pharmaceutical Industry. . Regulatory Requirements for pharmaceutical laboratories. . Factors affecting Quality of Medicines. . Discuss warning letters effecting the analytical labs. . Roles of the analytical Program. . Different types of Analytical Methods used to support Drug Development. Note: Use this Promo Code(102742) to avail Discount of 10% on LIVE Purchase. For More Details: http://bit.ly/dg1qha
How to conduct a software risk assessment that is meaningful

How to conduct a software risk assessment that is meaningful

Location: , United States
Category: Physical and Life Sciences
Start Date: 10-04-2010 Last Day: 10-04-2010
Get detailed understanding of how to perform risk assessment as part of 10 step risk based approach to CSV. Areas Covered in the Seminar: . How to use the risk-based approach to reduce validation time and lower costs. . Step-by-step instructions for performing and documenting a risk assessment, and how to use the results to reduce validation documentation. . Reduce testing by writing test cases that trace to elements of risk management. . Avoid 483s and Warning Letters. . Interactive real life examples. . How to identify risk and establish mitigations. . Determine risk in a process to reduce the…
Validate COTS Software in one-third the time

Validate COTS Software in one-third the time

Location: , United States
Category: Physical and Life Sciences
Start Date: 08-05-2010 Last Day: 08-05-2010
Understand 10 step Risk based approach to validation, explore methods to decrease resource requirements and make documentation more manageable and understandable. Areas Covered in the Seminar: . Learn which documents the FDA expects to audit. . Proven techniques that reduce software costs and implementation times. . Increase corporate productivity and individual workforce member productivity. . Efficiently create validation documentation. . Decrease resource requirements. . Make documentation more manageable and understandable. . Avoid 483s and Warning Letters. . How to implement a computer system to gain maximum productivity. . Use resources effectively to perform effective validation while avoiding doing too much.…
Developing Supplier Quality Auditor Training Programs

Developing Supplier Quality Auditor Training Programs

Location: , United States
Category: Physical and Life Sciences
Start Date: 09-21-2010 Last Day: 09-21-2010
In this webinar our expert trainer Jeff Kasoff will explain the best way to identify which employees can be the most effective auditors and how to train them. Areas Covered in the Seminar: . Importance of the Audit Team Coordinator. . Auditor Selection. . Auditor Training Requirements. . Auditor Responsibilities. . Audit Planning. . Pre-audit Preparation. . Audit Performance. . Post-audit Requirements and Tasks. Who Will Benefit: This webinar will provide valuable assistance to all companies that are subject to FDA regulations, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include: . Top management…
Excel Spreadsheets - Develop and Validate to Eliminate 483s

Excel Spreadsheets - Develop and Validate to Eliminate 483s

Location: , United States
Category: Physical and Life Sciences
Start Date: 11-05-2010 Last Day: 11-05-2010
Learn how to Use excel spreadsheet for GXP data and reduce validation cost and time. Configure Excel for audit trails, security features, and data entry verification. Areas Covered in the Seminar: . Become compliance when using Excel spreadsheets for GxP data. . Reduce validation time and costs. . Increase compliance while lowering resource needs. . Avoid 483s and Warning Letters. . Understand what validation documentation is required. . How to use Excel’s audit trail. . Hands on workshop to address your specific needs. . How to use cell and file protections. For More Details: http://bit.ly/dqBloH
Changes in US FDA Enforcement

Changes in US FDA Enforcement

Location: , United States
Category: Physical and Life Sciences
Start Date: 08-10-2010 Last Day: 08-10-2010
This FDA Compliance training will discussion on major changes in FDA enforcement and how the regulated industry should respond to any FDA inspection activity. Areas Covered in the Seminar: . Pressures on FDA. . FDA Re-organization. . FDA changes in focus. . New Enforcement Resources. . What industry should expect of FDA. . FDA expectations for responses to FDA-483 observations. . FDA expectations for responses to Warning Letters. Note: Use this Promo Code(102040) to avail Discount of 10% on LIVE Purchase. For More Details: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701699?channel=worldconf
U.S. FDA cGMP Compliance Audits -- Raising the Bar

U.S. FDA cGMP Compliance Audits -- Raising the Bar

Location: , United States
Category: Physical and Life Sciences
Start Date: 08-03-2010 Last Day: 08-03-2010
This FDA cGMP training webinar will discuss US FDA’s approach to cGMP Audits and expectations from companies. It will also evaluate chief concern areas of cGMP compliance audit and anticipatory emphasis changes as per new regulatory climate. Areas Covered in the Seminar: . The "target". . Avoid complacency from past "good" FDA audits. . Avoid complacency from just completed "good" ISO audits. . The desired response. . How to respond now -- where to shift focus first. . Where to direct scarce resources. . A risk-based phased approach. . Maintain 'the edge'. Note: Use this Promo Code(101642) to avail Discount…
Navigating Pediatric Trials from recruitment to successful on-time completion

Navigating Pediatric Trials from recruitment to successful on-time completion

Location: , United States
Category: Physical and Life Sciences
Start Date: 09-16-2010 Last Day: 09-16-2010
In this Pediatric Trials training learn how to evaluate the current issues and best practices in pediatric drug development, clinical investigation of medicinal products and non clinical evaluation of pediatric drug products. Areas Covered in the Seminar: - Compilation of various regulatory and guidance documents from the FDA and OHRP on the conduct of research involving children. - Recent guidances on compliance and general considerations in the conduct of research on children. - General Considerations for the Clinical Evaluation of Drugs in Infants and Children. - Discuss Clinical Investigation of Medicinal Products in the Pediatric Population. - Nonclinical Evaluation of…
The 6 Most Common Problems in FDA Software Validation & Verification - FDA Validation Webinar By ComplianceOnline

The 6 Most Common Problems in FDA Software Validation & Verification - FDA Validation Webinar By ComplianceOnline

Location: , United States
Category: Physical and Life Sciences
Start Date: 08-22-2012 Last Day: 08-22-2012
This FDA Software Validation and Verification training/webinar will review the validation planning process with particular emphasis on avoiding six common pitfalls. Areas Covered in the seminar: - Outline of FDA regulations as applied to software. - Review of FDA software validation requirements. - Why validation makes good business sense. - The 6 Most Common Problems in FDA Software Validation & Verification. - Strategies on how to avoid the most common problems. - Advice on successful validation project staffing.
Drug Master Files (DMF) Training

Drug Master Files (DMF) Training

Location: , United States
Category: Physical and Life Sciences
Start Date: 07-29-2010 Last Day: 07-29-2010
In this Drug Master Files (DMF's) training learn how and why the DMF's is submitted to FDA and how it intended to be used. Areas Covered in the Seminar: - Introduction. - Definitions. - Types of Drug Master Files. - Submissions to Drug Master Fines. - Drug Master File Contents. - Format, Assembly and Delivery. - Authorization ro Refer to a DMF. - Processing and Reviewing Policies. - DMF Holder Obligations. - Transfer of Ownership. - Closure of a DMF. Note: Use this Promo Code(101460) to avail Discount of 10% on LIVE Purchase. For More Details: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701704?channel=worldconf
Product Risk Management - ISO 14971 and ICH Q9

Product Risk Management - ISO 14971 and ICH Q9

Location: , United States
Category: Physical and Life Sciences
Start Date: 07-27-2010 Last Day: 07-27-2010
In this Product Risk Management webinar learn how to develop and implement product risk management planning. Understand the Key requirements of ISO 14971 and ICH Q9. Areas Covered in the Seminar: - Key requirements of ISO 14971 and ICH Q9. - Suggested formats to meet both FDA and MDD requirements. - Expected sources of information for evaluation and inclusion. - How to compile. - When to involve the team. - How to complete, document and control as a 'living' document. - An often neglected safety feature. - Effectiveness -- Determining and Monitoring. - Realizing real cost savings. Note: Use this…
How FDA trains its investigators to review CAPA (FDA compliance program guidance manuals, QSIT manual) and what should you do to prepare

How FDA trains its investigators to review CAPA (FDA compliance program guidance manuals, QSIT manual) and what should you do to prepare

Location: , United States
Category: Physical and Life Sciences
Start Date: 07-22-2010 Last Day: 07-22-2010
This CAPA investigation training webinar will discuss FDA’s techniques to do CAPA inspection, what the FDA tells their inspectors to focus in the QSIT document and how your company can use the QSIT document to prepare for inspection. Areas Covered in the seminar: - How to prepare for an FDA inspection? - Development and contents of an SOP for FDA inspection. - Reliance of FDA inspectors on compliance program guide manuals. - Reliance of FDA inspectors on other external sources. - Personnel training before inspection. - In depth review and summary of QSIT. - Use of QSIT for internal auditing.…
How do I keep FDA happy with my contract manufacturer?

How do I keep FDA happy with my contract manufacturer?

Location: , United States
Category: Physical and Life Sciences
Start Date: 09-08-2010 Last Day: 09-08-2010
This Quality System Regulation training we will review the sections of Quality system regulations, design control regulations which FDA uses as an inspection tool. Actual FDA investigator training methods related to design control inspections. Real life examples of FDA design control compliance issues will be examined. Areas Covered in the Seminar: - Introduction. - Guidance documents QS regulation. - Major FDA 483 points. - Trends in FDA. - Determining best practice for the supplier audit. - Conducting a thorough audits. - FDA import detention prevention. - Questions to ask during the supplier audit. - Questions & Answers. For More Details:…
Understanding and Implementing ISO 17025 - Webinar By ComplianceOnline

Understanding and Implementing ISO 17025 - Webinar By ComplianceOnline

Location: , United States
Category: Physical and Life Sciences
Start Date: 08-30-2012 Last Day: 08-30-2012
This webinar will provide a detailed information on the critical requirements of ISO 17025 and recommendations for cost effective implementation. You will learn steps towards laboratory accreditation and how to prepare for an ISO 17025 audit. Areas Covered in the seminar: - Benefits of ISO 17025. - Management requirements. - Technical requirements. - Documentation requirements. - Steps towards ISO 17025 laboratory accreditation. - ISO 17025 and agencies, such as US FDA. - Impact on Analytical Laboratories. - Recommendations for implementation. - Dealing with multiple quality systems. - Preparation for an ISO 17025 Audit. - Local and global resources. For Registration:…
Health-Related Quality Of Life Research – FDA and Pros: What to Do In 2010 and Beyond?

Health-Related Quality Of Life Research – FDA and Pros: What to Do In 2010 and Beyond?

Location: , United States
Category: Physical and Life Sciences
Start Date: 07-23-2010 Last Day: 07-23-2010
Why Should You Attend: Health related quality of life (HRQOL) research is designed to measure patients’ input into the effects of disease and/or treatment and possibly to distinguish between treatments or devices; however it is fundamentally different than traditional medical assessments. HRQOL is not efficacy or safety, yet it can provide an alternative and valuable medical insight. This webinar presents an introduction to HRQOL that will crystallize knowledge of underlying concepts, strategies, and processes; it will facilitate the attendees’ ability to be conversant, to assist in planning studies, and to avoid common mistakes. Additionally, it is designed to allow for…
FDA's new enforcement initiative – Strategic Software Validation Planning for Executives and Managers

FDA's new enforcement initiative – Strategic Software Validation Planning for Executives and Managers

Location: , United States
Category: Physical and Life Sciences
Start Date: 06-27-2012 Last Day: 06-27-2012
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…
Hydrology Conference 2010

Hydrology Conference 2010

Location: , United States
Category: Physical and Life Sciences
Start Date: 10-11-2010 Last Day: 10-13-2010
This major international conference, taking place in San Diego, USA, October 11 – 13, 2010, will target the developing interdisciplinary science themes in the interface between hydrology and other scientific disciplines, including climate change, biology, chemistry and social sciences. These subjects are of particular relevance as population increases and a changing climate bring new pressures on hydrological systems around the world.
5th Annual Generics Asia Summit

5th Annual Generics Asia Summit

Location: , Singapore
Category: Physical and Life Sciences
Start Date: 10-25-2010 Last Day: 10-26-2010
The 5th Annual Generics Asia Summit will bring together C-level decision makers from Generics companies, innovator pharma companies, payers, investors, regulators and health authorities to discuss business strategy and to form partnerships in an evolving industry landscape. This is the only event in Asia to have truly substantial and relevant discussions on the hottest issues such as leveraging on brands, biosimilars, regulatory updates and collaboration opportunities between innovator pharma and traditional generics companies. Whether you have or plan to invest in the regulated, semi-regulated or unregulated markets , this event will provide you with actual case studies on how to…

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