Quality & ISO 9000 Compliance Management Training

This Radiopharmaceuticals training will set out guidance and advice for those interested in setting up or improving an existing facility. Radiopharmaceutical manufacture is starting to begin a new phase as FDG now has a product licence

This Internal Audit Approach training/webinar is designed to enhance your understanding of process auditing techniques Using interactive examples and a case study.

Pilot has provided training in auditing since 1995 using her Three Step System Approach for Auditing and her Five Steps in performing audits This presentation cover in simple terms the five steps to conduct audits and the working documents required. 1 - Initiating, 2 preparing, 3 Conducting - opening/closing meetings, collecting evidence, findings, 4 Audit reports, 5 Audit completions.

This Management control training will provide the principles and practices needed to effectively develop and implement the Management Controls to ensure an effective Quality Management System and to comply with the FDA QS Regulation.

This Validation training will provide valuable assistance to all regulated companies that need to validate their systems. Project management is the application of knowledge, skills, tools, and techniques to manage project activities to meet project requirements

This training will identify and review the key planning documents, including team assignments, management and conduct of the project, project phases, and regulatory requirements and scheduling.

This Quality training will help you look holistically at your quality systems and embrace a continuous improvement approach that will drive quantifiable business benefits. A quick review of your log of corrective and preventive actions can be quite revealing. Many executives have found that their past improvement initiatives only addressed problem areas regarding individual products.

In this Packaging & Labeling training we take on what is probably P.E.T. greatest nemesis -- especially for those manufacturing and using P.E.T. Bottles in warm climates.

This Validation training will provide valuable assistance to all regulated companies that need to validate their systems and will introduce measurement validation using Gauge R&R. Will introduce measurement validation using Gauge R&R. R&R standing for Repeatability and Reproducibility

The principles and practices needed to effectively develop, implement, and perform internal quality management system audits that comply with the requirements of the FDA QS Regulation and ISO 13485. This medical Device training will provide the principles and practices needed to effectively develop, implement, and perform internal quality management system audits that comply with the requirements of the FDA QS Regulation and ISO 13485.

This webinar will provide valuable assistance to all regulated companies that utilize third party vendors that provide products or services to the companies or to the customers or clients of those companies The most critical areas focus on the identification of the need for additional third-party services, development and adoption of the Vendor Management and Oversight Policy, the selection of qualified vendors (including the development of the Request for Proposal and bid process), the contract development and award, ongoing review, and nondisclosure and confidentiality concerns

This webinar will provide guidance on how to audit the more difficult areas of a quality management system The applicable ISO 9001:2000 requirements will be examined for each of these difficult areas and then suggestions made on how to more effectively audit them

In this Quality compliance training topics will be related to the risk assessment, control selection and risk treatment plan for developing an Information Security Management system that is capable of accredited certification to ISO/IEC 27001:2005. This is a part of a series of webinars that support those considering or developing an Information Security Management system that is capable of accredited certification to ISO/IEC 27001:2005.

This Quality compliance training will present and identify ways that your (ISO 9001 8.2.3) process monitoring and measurement tools can Lead your organization to fast and efficient corrections when problems occur.

This Internal Audit training will provide valuable assistance to organizations desiring to comply with ISO 9001:2000 and will provide the internal audit functions with methodology and tools to better perform internal audits.

This Environmental Management training will discuss the advantages of a company’s management system to the international standard’s requirement and a simple to follow, Three Step Process for its implementation.

The purpose of this webinar will be to present and identify ways that your quality objectives can Provide and identify improvement opportunities for your system's maintenance and ongoing health. The purpose of this webinar will be to present and identify ways that your quality objectives can Set the tone for using your quality policy statement,Provide a guideline for Top Management’s direction for the organization,Identify improvement opportunities within your system leading to greater reliability.

Many small or virtual companies make one of two common mistakes: their Quality Management System (QMS) is either too cumbersome for their operation or they don’t have a quality management system at all Quality management issues facing small, startup or "virtual" companies and identifying all required quality management system elements.

This CAPA session will discuss these common pitfalls and share best practices, strategies and techniques on how to deal with CAPA system in relation to Warning Letters and 483 citations. In 2005 greater than 50% of FDA Warning Letters and 483 citations were CAPA related.

In this CAPA training learn how to utilizing multiple data sources to detect actual and potential nonconformities.