World Conference Calendar

34363 Conferences

Physical and Life Sciencesrss


What are the “Good Clinical Practices” (GCP) of Research involving Human Subjects

What are the “Good Clinical Practices” (GCP) of Research involving Human Subjects

Location: , United States
Category: Physical and Life Sciences
Start Date: 09-21-2010 Last Day: 09-21-2010
In this GCP webinar understand The Regulatory requirements to follow to be GCP compliant for a site involved in research involving human subjects. Areas Covered in the Seminar: - The historical background of why the GCP standards were developed. - The concept of and the purpose of ”GCP”. - The twelve ICH Principles of “GCP”. - The ICH definition of “GCP” and how it is applied. - The Regulatory requirements to follow to be GCP compliant. - Who, in the clinical research team is responsible that GCP is followed? - How to be sure CPU / Site staff know their…
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…
Forced Degradation Studies/ Biologics Stability Programs for Biopharmaceuticals

Forced Degradation Studies/ Biologics Stability Programs for Biopharmaceuticals

Location: , United States
Category: Physical and Life Sciences
Start Date: 09-17-2010 Last Day: 09-17-2010
This training on Forced Degradation study on a Protein Therapeutic will discuss on the Forced Degradation Studies required for Well Characterized Protein Therapeutic products and how to leverage forced degradation results to design stability studies for Drug substances. Areas Covered in the Seminar: - The goal of Forced Deg studies . - Stress conditions for Forced deg studies. - Degradants generated by these stress conditions. - Methods required to study these degradant. - Leveraging forced deg results to design stability studies. - Using forced deg results in specification setting. - Common pitfalls in Biologics Stability Studies. - Types of deficiency…
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…
Risk Assessments - Key to a Viral Safety Management Plan

Risk Assessments - Key to a Viral Safety Management Plan

Location: , United States
Category: Physical and Life Sciences
Start Date: 09-15-2010 Last Day: 09-15-2010
This Viral Safety webinar training will discuss the testing used to generate data for risk assessment and train how to calculate viral risk. Learning objectives : How do I know if the viral clearance my process provides is enough? Retrovirus or Retroviral like particles are present in my production cell line. How does this impact my downstream process? How do I calculate viral risk? Areas Covered in the seminar: - The viral testing required for source materials. - Determine if there is enough viral clearance for your process . - How the testing for adventitious viruses is related to viral…
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 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:…
Transformation to a High Quality Culture for FDA Regulated Industries

Transformation to a High Quality Culture for FDA Regulated Industries

Location: , United States
Category: Physical and Life Sciences
Start Date: 09-02-2010 Last Day: 09-02-2010
This FDA Regulated Industries training/webinar will show you best method available today to make step-change improvements quality performance. Your will learn how to harness the ideas and energy of your employees for quality improvement. Areas Covered in the Seminar: - How to use measurements to drive behavior change - Why even the strictest of procedures and extreme supervisory oversight cannot achieve the level of quality performance you need to remain competitive - How to motivate your employees to follow up on their own initiatives to implement positive change in the workplace - How to guide your employees to maximize their…
Full day Virtual Seminar - Effective Computer System Validation and software implementation to reduce cost and time

Full day Virtual Seminar - Effective Computer System Validation and software implementation to reduce cost and time

Location: , United States
Category: Physical and Life Sciences
Start Date: 09-01-2010 Last Day: 09-01-2010
In this CSV seminar learn how to reduce validation project time, efficient documentation strategies, enhance system productivity and increase compliance 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.This course 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…
Streamline Documentation System in Pharmaceutical Laboratory

Streamline Documentation System in Pharmaceutical Laboratory

Location: , United States
Category: Physical and Life Sciences
Start Date: 08-31-2010 Last Day: 08-31-2010
This laboratory documentation training Webinar will discuss the GMP requirements on laboratory records and how to streamline documentation system. Areas Covered in the Seminar: - Review cGMP requirements on laboratory records. - Define raw data. - Key factors of an effective documentation system. - Anatomy of an SOP. - Consequences of poor data records. - Discuss warning letters effecting the analytical data. Who Will Benefit: - Pharmaceutical scientists - Manufacturers or raw material and ingredients - Analysts and lab managers - QA managers and personnel - Regulatory affairs
The 8th International Conference on Recirculating Aquaculture

The 8th International Conference on Recirculating Aquaculture

Location: , United States
Category: Physical and Life Sciences
Start Date: 08-20-2010 Last Day: 08-22-2010
ICRA topics are still developing. We encourage those who may be interested in the ICRA to save the date. Those who wish to submit potential ICRA topics should email Terry Rakestraw at aqua@vt.edu
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
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.…
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…
II International Congress on Biodiversity of the Guiana Shield

II International Congress on Biodiversity of the Guiana Shield

Location: , Brazil
Category: Physical and Life Sciences
Start Date: 08-01-2010 Last Day: 08-04-2010 Deadline for abstracts: 12-10-2009
The objective of the conference is to discuss advances made on biodiversity research in the Guiana Shield and to share experiences in the use and management of biodiversity.
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…
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…
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.…
Australian Desalination Summit

Australian Desalination Summit

Location: , Australia
Category: Physical and Life Sciences
Start Date: 07-15-2010 Last Day: 07-16-2010
The summit will cover a variety of topics, including surveys of desalination plants and projects, exploring the challenges and new trends in the industry, meeting environmental and technical challenges, discussions on water quality issues and reverse osmosis technologies, challenges of designing a desalination plant, environmental impact on desalination plants, impact of blending desalinated sea water with conventionally treated sea water, and capacitive deionisation as a low energy desalination alternative. There will be panel discussions on the true cost of water desalination and on key issues and challenges of desalination projects.

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