Quality & ISO 9000 Compliance Management Training

This training program on applicable regulations pertaining to clean room environmental monitoring (EM) programs will discuss the basics of setting a robust and effective EM program. The course will also detail the relationship between an EM Excursion Program and CAPA and the four phases of clean room transitional monitoring.

The objective of any report is to provide important information to management in the area reviewed. It represents the end result of weeks of reviews, analyses, interviews and discussions. The quality of that report will have an impact on how well the report is understood and accepted. This training program will review the audit standards related to audit report quality and encourage attendees to participate in various quality report exercises.

With the release of ISO 9001:2015 September 23, 2015, now is the time to prepare. This 9001-2015 Risk Based Thinking training program will highlight the changes from the ISO 9001:2008 revision. A key change is the addition of risk based thinking, and the training includes group exercises to reinforce this new process.

This webinar will highlight the current statistics and trends regarding product recalls, product liability lawsuits, and the causes of these economic disasters for manufacturing corporations. It will also identify all the areas of manufacturing management that are typically not being handled properly and contribute to such failures, from product development thru marketing, product testing, supplier selection and control, document management, contracts and agreements, manufacturing quality, and incident investigation.

This training course will provide a detailed overview of the regulatory requirements, local challenges and important cultural aspects of working with the lifecycle of life science products (pharmaceuticals, medical devices, biologics and combination products) as an importer or producer in Russia. It will offer a deeper understanding of cultural norms, and will discuss best practices for establishing relationships and protecting your intellectual property to be integrated into your company’s training and corporate business strategies.

This training program will discuss how to effectively create performance metrics and goals for your department or project. It will also discuss the key components of a metric and when to use different types of performance metrics.

This training program will provide attendees with the ultimate set of tools in order to help their firms properly create User Requirement Specifications (URS) for Computer Systems Validation (CSV) with emphasis on current industry trends in this particular area as well as current Food and Drug Administration (FDA) regulatory trends and enforcement activity.

This training program will help find the dots relating to AP internal controls and connect them. The course will include: processes of formulation and implementation; how to develop steps for internal controls; how to develop tools for internal controls; how to benefit from these tools and more.

This Internal Quality Audit training is presented as a practical way for an organization to evaluate its internal audit program and make required improvements.

This 90-minute Internal Audit webinar will cover the three foundational elements that support an effective Internal Audit program - establishing Internal Audit Program objectives, developing audit plans, and writing effective non-compliances.

This Quality inspection training will teaches tools and techniques that can be employed to get to the “root cause” of unexpected quality events, and to resolve them in a manner such that they stay resolved in a GMP compliant manner.

The webinar provides a comprehensive and logical way to think about performance goals, metrics and the evaluation of goal progress.

This webinar will focus on designing a thorough internal audit set of process tools, accurately captured in your internal audit procedure that will provide many years of payback and dividends for your organization.

Emphasis is placed on conducting effective process auditing through an internal audit program within a company’s quality management system. This webinar is intended to review the requirements for determining if a company has its processes under control, with reviews of the requirements and description of the methods to determine which processes are expected to be audited.

This webinar will provide valuable assistance to all regulated companies that need to audit any department, process or procedure, financial records, assets, etc. This program will look at the formation and interpretation of the ICQs, narratives, flowcharts, as well as the proper design for the audit steps.

This program will lay the foundation for subsequent webinars. but can be used as a starting point for the development of any audit program. The goal is to have a program that is comprehensive enough to guide the auditor(s) through the testing of an adequate number of areas, the documentation of the findings and conclusions based on quantitative data, and the presentation and recommendations based on the findings

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

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

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.