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Meeting Global Unique Device Identification Requirements

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  Meeting Global Unique Device Identification Requirements: Regulation, compliance seminars and Best Practices Requirements around Unique Device Identification (UDI) are evolving. Despite efforts by the Global Harmonization Task Force and International Medical Device Regulator Forum to integrate global expectations, national guidelines have continued to develop in differing ways. Even now, when the deadline for final implementation of Class I products is quickly approaching in the United States and UDI timelines in the EU remain unchanged due to COVID-19, regulatory bodies in other countries are starting to implement their own new programs. For a company working to manufacture and deliver products around the world, meeting all these needs is complicated. If you’re searching for the best way to fulfill the competing needs of various identification requirements or hoping to find the most efficient way to appropriately identify your product in different global markets, this webinar has yo
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Trends in FDA Compliance and Enforcement for Regulated Computer Systems

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  FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit. As a “GxP” system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements . If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA’s CFR Part 11 guidance on ER/ES must be followed.   This webinar will focus on the key areas that are most important, including security and data integrity. Implementing and following the System Development Life Cycle (SDLC) methodology is the best approach for computer system validation and maintaining data integrity. The life cycle approach takes all aspects of validation into account throughout the life of the sys
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Quality and GMP Compliance for Virtual Companies (Pharmaceutical and Biologics Industries)

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  Course Description - Today, many companies operate on an outsourcing model. This is very common for companies who are evolving from being mainly development-focused to a point where they are entering latter stages of Phase 2 or Phase 3 clinical trials, and plan to have a product ready for market approval in the coming months. Most such companies are small, and may not have deep expertise in QA and GMP compliance seminars , relying on their partners to cover those areas. Companies who outsource the majority of operations through the use of Contract Manufacturing Organizations (CMOs), Contract Research Organizations (CROs) and Contract Laboratories, however, remain responsible for the quality and compliance status of the products they send to the clinic or to the marketplace. In this two day workshop conference you will learn the requirements and expectations of major health care regulators that are applicable to "virtual" companies. You will learn how to diagnose your compa
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General Data Protection Regulation (GDPR) Compliance Training

  The General Data Protection Regulation (GDPR), introduced by the European Union, took effect on May 25, 2018. This regulation has changed how organizations handle personal data of data subjects, including customers, employees, and prospects. Organizations had to revamp their processes and systems to be compliant with the new stringent data protection standards. The purpose of the GDPR is to create better data protection policies and to hold the organizations that handle personal data more accountable. But the transition isn’t easy. The new processes have to be systemic and self-serving rather than ad hoc, manual, and intrusive. This Compliance Seminar would help organization which is affected by the GDPR. It includes a comprehensive and structured plan to achieve GDPR compliance Why should you attend With the introduction of the GDPR, organizations are under intense scrutiny regarding how they use the personal data of customers, employees, and prospects. Non-compliance can lead to h
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Good Manufacturing Practices Training | GMP Course

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Training on current Good Manufacturing practices is necessary to ensure that companies maintain their obligations to producing pure and safe drugs and medical devices. This training is intended to ensure that companies are aware of their obligations working in a field regulated by this guidelines training on current Good Manufacturing practices is necessary to ensure that companies maintain their obligations to producing pure and safe drugs and medical devices. This training is intended to ensure that companies are aware of their obligations working in a field regulated by these guidelines Why Should You Attend Current Good Manufacturing Practices (cGMP) are a series of guidelines that are intended to regulate the production of drugs and medical devices to ensure that they are produced in a safe manner. During this training, you will get an understanding of why they were developed, and how they shape the everyday procedures that oversee any given company’s work in this field. The or
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