world compliance seminars
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Online Regulatory Compliance Training. Trends in FDA compliance seminars and Enforcement for Regulated Computer Systems. 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.
Quality and GMP Compliance for Virtual Companies. 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. An Advanced Course on Lean Documents. Overview In this Lean Documents, Lean Configuration, and Document Control training learn the different types of lean documents and the usage of lean document principles; types of controlled documents; examples of lean and non-lean controlled documents.
Pros and cons of lean vs. non-lean documents. Online Regulatory Compliance Training. Online Regulatory Compliance Training. Online Regulatory Compliance Training. 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. 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. GDPR lays out a set of rules with which organizations need to be compliant. In this webinar, you will learn steps to achieve GDPR compliance. World Compliance Seminars. Joy McElroy Principle Consultant at Maynard Consulting Company Course Description The various regulatory agencies have expectations that pharmaceutical manufacturers will demonstrate control over their manufacturing equipment.
The FDA's findings of deficiencies concerning equipment validation indicate the agencies expect definitive evidence that the equipment qualification and validation schedules of a facility will satisfactorily control their manufacturing processes. An Advanced Course on Lean Documents. Good Manufacturing Practices Training. Quality Control Laboratory Compliance — cGMPs and GLPs Training. Basics of FDA law and regulations for QC laboratories What is adulteration?
PharmaceuticalsBiologicsMedical DevicesFoodsCosmeticsWhat is CGMP? PharmaceuticalsBiologicsMedical DevicesFoodsCosmeticsWhat is GLP? What is AIP? Contract LaboratoriesFDA inspection methodology. World Compliance Seminars. Overview As social media use explodes, companies in FDA-regulated industries will need to understand the current and pending regulations in order to meet compliance requirements.
The attendee will be provided with the FDA’s current thinking and the rationale behind it. The attendee will also learn ways to meet compliance objectives in a cost-beneficial manner.. World Compliance Seminars. Compliance Seminars: worldcompliance — LiveJournal. 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. 21 CFR Compliance Training. Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar.
Virus Risk Management in Food Industry. Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar Join us for a webinar on July 24 for a discussion of the webinar A webinar is prepared to explore the importance of virus risk management.
Food producers and risk managers must be aware of the potential for outbreaks. In the event of an outbreak, they should understand the need for complete cooperation with investigators in an effort to identify effective corrective actions and reduce the public health impact of the event. Understanding how virus can affect the food supply chain either directly or indirectly has significant impact on the food security particularly if the virus cause pandemic. Why Should You Attend Most of the food industry will be puzzled how to react to any epidemic or in worst case pandemic issue and how this could affect their supply chain either backward or forward in the chain.
Biosafety & Blood Borne Pathogen Safety. Webinar Includes : All the training handouts , certificate ,Q/A and 75 mins Live Webinar Join us for a webinar on August 05 for a discussion of the webinar The Centers for Disease Control and Prevention (CDC) has created regulations and guidelines that are recommended while working with biological materials, specifically, with blood borne pathogens. Join this webinar as we review these guidelines. Pharmaceutical Training Courses Online.
“Great session. I learned a lot” Chief HR Professional" “Wow! I had an opportunity to attend the HR audit workshop. It is spectacular and I found it very valuable. World Compliance Seminars.