Sample Re-Analysis
ComplianceOnline.com is focused on enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality and safety. Their seminars include Laboratory Investigations Relating to Sample Re-Analysis: Co. this training will provide guidance on procedures investigating unexpected results for non-clinical and clinical trials. This seminar includes several suggested procedures in addition to avoiding unnecessary sample re-analysis.
Reasons for you to attend this seminar are that unexpected results in acceptable assays usually reflexively trigger calls for sample re-analysis by clinical managers or non-clinical study directors. Before sample re-analysis is initiated compromising the sample, investigators must rule out pre-analytical errors, mislabeling, misdosing, delayed or accelerated sampling, subject variables including concurrent meds, fasting compromised, etc. attending the seminar will allow you to understand the several suggested procedures that will hopefully help you avoid unnecessary re-analysis. If reanalysis is still indicated at the end of your investigation, this session will suggest procedures.
The seminar covers a wide range of topics including FDA restriction and guidance covering sample re-analysis and the establishment of complaint handling program. You will learn what constitutes valid re-analysis as well as CRM/CRA/Medical Officer requests for re-analysis. Other topics covered will be pre-analytical errors and investigations, analytical errors and investigations. It will provide valuable assistance to all regulated companies since sample re-analysis will arise across the diagnostic, pharmaceutical, and biologics fields.
Laboratory Investigations Relating to Sample Re-Analysis will benefit laboratories, regulatory management, QA management, clinical research managers and associates, sales personnel, consultants, and quality system auditors. The training duration is for 60 minutes and you also have the training options of the recorded version only or the training CD only.
Those who are concerned with learning approaches to efficiently develop assays when doing sample re-analysis can also choose the Validation of Bioanalytical Assays for Biologicals. This webinars describes logical approaches to efficiently develop assays that will deliver quality data. It offers an understanding of the strategic management of the pharmacokinetic profile of a drug which is a critical determinant of therapeutic success in the clinic. Successful development and validation of the bioanalytical assays that support these studies are key components to the process and you will learn the logical approaches to efficiently develop assays that will deliver quality data.
The sample re-analysis seminars from ComplianceOnline will let you get your toughest quality and compliance problems solved by world renowned experts. You can ask a question and receive multiple answers from a variety of multiple experts and users so that you have the option of choosing the one that best solves your particular problem. ComplianceOnline.com is your resource for the training you need that affects your industry though online webinars. You can learn the best practices and download quality standards, checklists and news articles. Whether you need information on sample re-analysis or risk management, or for whatever industry you are in, they have the webinars to make you compliant.
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