World Compliance Seminars

  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

  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

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

Documentation is a critical tool for ensuring GxP/GMP compliance and GMP Training In the regulated environment which must be GxP/GMP compliant, document control is the cornerstone of the quality system. It is so important that if an external audit identifies deficiencies in the document control system, the entire organization can be shut down. There are also GMP requirements for information technology. For a drug to be produced in a GxP/GMP compliant manner, some specific information technology practices must be followed. Computer systems involved in the development, manufacture, and sale of regulated product must meet certain requirements. Change control within quality management systems (QMS) and information technology (IT) systems is a formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner. In the regulated industries, manufactures are required to use a change control procedure. In this webinar, the connection between

When considering what to focus on for compliance and internal audits, there is no better source of information about issues to avoid than the list of enforcement actions taken in HIPAA compliance that have resulted in penalties for the violators. The details of the enforcement actions, including the reasons, penalties, and corrective action plans involved with each, provide indicators of issues to be on the lookout for, that can cause significant pain if left unaddressed. In addition, the maximum penalties for HIPAA violations have been revised, so that the maximums for each tier of a violation more closely reflect the maximums identified in the HITECH Act, and are now related to the culpability of the organization. Organizations that try to meet requirements will receive lower maximum fines than those that are negligent. And the maximums have also been revised to reflect a cost-of-living increase. The random HIPAA Compliance Seminars Audit program had a year of trial audits in 2012

Contract research organization, also called a clinical research organization (CRO), is an entity that offers fee-for-services support primarily to manufacturers of medicinal products and biotechnology companies. By the very nature of the business and the clients they serve, CROs must be up to date on the most current regulatory agency requirements for medicinal product testing, manufacturing and agency filing. It is important to select a CRO for success. Depending on organization, CRO services may include laboratory analysis, experimental design, product development, manufacturing, product formulation, and others. In this webinar we will describe how to select a CRO, the selection criteria of CRO, things to consider before selecting a CRO, what to look for, and how to ensure the right choice. We will describe a role of Quality Assurance (QA) role in selecting a CRO. Why Should You Attend Compliance Seminars Outsourcing work is an integral part of business in regulated industries. Selec