World Compliance Seminars

  Excipients are the substances that are in any pharmaceutical preparation besides the drug. From ingredients that improve drug delivery, to ingredients that improve stability of the drug to ingredients which improve the color and taste of the drug, each component has a key role in pharmaceutical delivery and must be evaluated as such Why Should You Attend Excipients must be evaluated with each drug they are included with to ensure that they can be used safely while ensuring the drug can be used as intended. However, there are a number of challenges with excipient testing. Balancing the needs of the various compendials, such as USP, EP and JP, with cGMP can be a challenge. The goal of this webinar is to ensure that you know what needs to be done for each type of testing, the goals of each, and how you can use the various components of testing to reinforce each other to ensure the proper usage of excipients. Webinar Takeaway Types of excipients Compendial excipient t...

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...