This 2 day interactive course on in-vitro diagnostics is structured to understand the different set of IVD regulations, how to navigate through this maze of IVD regulations, and to win regulatory approvals. This In-vitro Diagnostics (IVD ) course will make the attendees understand the IVD regulations and develop regulatory strategies that secure regulatory approvals.
Learning Management Systems (LMSs) are important tools for assuring and demonstrating that Pharma employees maintain their training, and their GMP compliance, up to date.
They often boast great functionality but also have limitations that must be overcome for a Pharma company to use them effectively. An area that is not understood well is the development of training curricula in these systems, which presents its own unique challenges and takes far more time to implement than is commonly thought.
In addition, many employees have these responsibilities in addition to others not necessarily related to training and do not have the luxury of time to create and maintain a complex array of curricula.
Hazardous materials pose a danger to the environment. Federal regulations require immediate reporting to specific agencies (federal and local) in the event of a release to the environment.
We will cover the diferrent requirements, how to determine if you are required to report a release, and strategies to implement proactive actions to minimize the likelihood of a release, and you internal response time to avoid or minimize any potential enforcement actions.
Why you should Attend: The inspection requirements of the SPCC rule are designed to detect oil leaks, spills, or other potential integrity or structural issues before they can result in a discharge of oil to navigable waters of the U.S. or adjoining shorelines.
Regularly scheduled inspections, evaluations, and testing of bulk oil storage containers by qualified personnel are critical parts of discharge prevention. A container integrity inspection and/or testing program may involve one or more of the following: an external visual inspection of containers, foundations, and supports; non-destructive testing (examination) to evaluate integrity of certain containers; and additional evaluations, as needed, to assess the containers’ fitness for continued service.
The type of inspection program and its scope will depend on site specific condition and the application of good engineering practices and this can be accomplished by following applicable industry standards.
Areas Covered in the Session:
CERLA Releases and Reporting
Harmful Discharges under the CWA
EPCRA Release Reporting
Chemical Safety Board (CSB) New rule
Who Will Benefit:
Robert A. (Bob) LaRosa, PE, is an environmental engineer and regulatory compliance specialist with more than 30 years’ experience supporting clients in the federal government and in a variety of industries, including chemical, petroleum, transportation, telecommunication, food processing, pharmaceuticals. He has developed and implements SPCC plans at more than 100 different facilities in the transportation, industrial, commercial and government sectors.
As a licensed Professional Engineer, Bob reviews and approves release reporting plans for his clients. Bob is an effective and practiced instructor, with experience delivering more than 60 courses to nearly 1,000 students.
FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment.
The program must include: intervals, scheduling, specific procedures, limits of accuracy/precision, and remedial action in the event that the equipment does not meet established requirements.
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.
Procedures for controlling electronic signatures and electronic records as described in the FDA Guidance will be explained.
FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records from being compromised with possible resulting harm to the patient. FDA has set up regulations that address both data security and patient safety. We will show how 21 CFR part 11 considers both.
The confusion over the original FDA regulation and its subsequent "selective enforcement" will be explained. FDA requirements for 21CFR Part 11 validation will be explained. the requirements are composed of technical and procedural aspects. open, closed and hybrid (paper and electronic) systems will be explained.
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Over time, there have been several misunderstandings between supplier / contractors and pharmaceutical / biologic finished product manufacturers.The root of many of the problems lies in a lack of a suitable agreement delineating roles, responsibilities and resolution to agreement to these issues. Part of these arrangements typically involve the development, support and updating of confidential technical files (Drug Master files) which allow suppliers to protect their confidential product and process information from each and every customer and share it only with the Agency.
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