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This session highlights understanding and mitigating the risks of POATMs that are being acknowledged and recognized by regulators and examiners.  In this webinar, we will discuss the areas that regulators and examiners are primarily focusing on in regards to POATMs. The areas of focus outlined in this webinar are based on best industry practices and supervisory experience.For More Details:  Email: david@grcts.com Tel: +1-248-233-2049 Web: www.grcts.com

This session highlights understanding and mitigating the risks of POATMs that are being acknowledged and recognized by regulators and examiners. In this webinar, we will discuss the areas that regulators and examiners are primarily focusing on in regards to POATMs. The areas of focus outlined in this webinar are based on best industry practices and supervisory experience.For More Details: Email: david@grcts.com Tel: +1-248-233-2049 Web: www.grcts.com

Email Marketing Best Practices

Email Marketing Best Practices [Infographic] - of recipients will forward emails with promos and coupons (and more cool stats)

This course will provide participants with a thorough understanding of the requirements of process validation for both small molecule (pharmaceuticals) and Biologic products. They will learn how to establish an effective process validation system and integrate it with other systems such as Risk Management, Corrective and Preventive Action and Supplier Management. For More Details:  Email: david@grcts.com Tel: +1-248-233-2049 Web: www.grcts.com

Process Validation for Drugs and Biologics

Description:  So much as changed and, because of the election, so much more is about to change. With the election of Donald Trump and transition to a Republican administration looming, employers are scrambling to predict what impact Trump will have on labor and employment policy and enforcement initiatives.

Description: So much as changed and, because of the election, so much more is about to change. With the election of Donald Trump and transition to a Republican administration looming, employers are scrambling to predict what impact Trump will have on labor and employment policy and enforcement initiatives.

Description:  Attend this briefing and demonstration on Excel to unleash its powerful sensitivity tools. Get the full power out of your financial models.  Improve the design of your models to take advantage of these tools in just 90 minutes. Financial analysis is an area of opportunity and risk.  Analysis should incorporate tests of sensitivity to changes in key variables using the most advanced tools available.  Typical financial models do not effectively utilize these tools.  This exposes…

Description: Attend this briefing and demonstration on Excel to unleash its powerful sensitivity tools. Get the full power out of your financial models. Improve the design of your models to take advantage of these tools in just 90 minutes. Financial analysis is an area of opportunity and risk. Analysis should incorporate tests of sensitivity to changes in key variables using the most advanced tools available. Typical financial models do not effectively utilize these tools. This exposes…

Description: Validation is an important element of the Quality System Regulations and ISO13485.   This course will cover the requirements the essentials of validation.  You’ll learn about what processes needed to be validated and what steps you need to take to validate processes.  You’ll learn the essentials of validation planning, protocol writing, and change management.  We’ll cover the steps of Installation Qualification (IQ),Operational Qualification (OQ), and Performance Qualification…

Description: Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements the essentials of validation. You’ll learn about what processes needed to be validated and what steps you need to take to validate processes. You’ll learn the essentials of validation planning, protocol writing, and change management. We’ll cover the steps of Installation Qualification (IQ),Operational Qualification (OQ), and Performance Qualification…

Description Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as HIPAA, Sarbanes Oxley Act and FDA's GxP and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality. Out-of-the box Excel® has not been designed for regulated environments.

Description Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as HIPAA, Sarbanes Oxley Act and FDA's GxP and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality. Out-of-the box Excel® has not been designed for regulated environments.

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