This webinar will help you ensure an efficient and effective CAPA process leading to improved quality and compliance for your company. You’ll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA this webinar is for you.
Clinical trials' data gives an accurate representation of what we measure to evaluate effects of the treatments under comparison. The clinical data recording process, however, as inspected/audited by inspectors/auditors is initiated with the recorded data, either in the Case Report Form, or in some other system, or in an electronic database.
From there, the data subjected to the process of data management is repeatedly inspected to ensure that the data that finally appear in the report are identical to the original, i.e. nothing untoward has happened on the way.
This webinar will help Sponsors, CROs in the US, EU and internationally,understand how to write SOPs to comply with inspection requirements.
Why should you Attend: The lack of or inadequate standard operating procedures (SOPs) continue to dominate the FDA's and other regulatory inspector's inspection observations. This is often caused by poor writing and management and control of SOPs. SOPs need to be easily understood by all those who have to follow them. Well written and effective SOPs are not only a regulatory requirements, they also make good business sense. Too often employees fail to follow SOPs because they can't understand them, and too many times we've seen procedures being constantly revised.
Managing clinical trials, of any size and complexity, requires strategic planning and efficient execution. As scientific advances continue, the types of therapies being developed have higher potency and novel targets; and increased pressure to have study designs that speed up clinical development.
In 2016, the ICH revised the E6 guidelines to further standardize processes in biomedical products development, decrease redundancies; and reflect the current research landscape such as increases in globalization, study complexity, and technological capabilities.
This course is designed to help you select sampling sizes and acceptance criteria for one-time studies like process validation, design verification, component qualifications and CAPA effectiveness checks including:
How to link risk with the confidence statements associated with the sampling plans
Identify a variety of sampling plans, that all make the desired confidence statements
Select from among these sampling plans that plan which offers the best balance between the number of units tested and the risk of failing the validation
How to identify when sampling plans for other properties are required for things like precision, accuracy, homogeneity and failure rates
This webinar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to human performance, and the difference between real human error and systems, process, and management deficiencies. Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 firstname.lastname@example.org Event link https://www.onlinecompliancepanel.com/webinar/Human-Error-Prevention-in-Pharmaceutical-Manufacturing-503932/SEPTEMBER-2018-ES-TRAININGREGISTRY
Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hybrid of both.
To assure the quality of raw materials, in process materials and finished goods, laboratory data integrity is assuming greater importance in CGMP for US FDA regulated industry. Data integrity and security infractions are not only 21 CFR Part 11 issues but also severe CGMP violations.
This 60-min webinar will familiarize participants with USP Chapter 1029 on good documentation guidelines, And This session will wrap up the general concept and will provide information as to what needs to be documented in certain records, Finally, you will know what kind of information to include in the most popular records dealt with in the manufacturing environment.
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection. Well written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed. More importantly, well written SOPs ensure that your personnel can consistently and accurately follow your processes resulting in correct outcomes and quality work.
In this webinar we will explain in detail the process of conducting a hazard analysis, We will explain how to integrate Human Factors studies into the Hazard Analysis and how to integrate Hazard Analysis into the design program, Hazard Analysis is the most powerful of the risk management tools described in ISO 14971 but it is very confusing.
The CMS Open Payments Rule (sometimes referred to as the "Physician Payment Sunshine Act") was born out of the Affordable Care Act. This presentation will walk you through the requirements under the regulation and discuss the logistics and strategies for compliance.
Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 email@example.com Event link https://www.onlinecompliancepanel.com/webinar/Compliance-with-the-CMS-Open-Payments-Rule-Sunshine-Act-504674/AUGUST-2018-ES-TRAININGREGISTRY
Learn how to write SOP and work instructions and explore the true purpose and function of compliance documents. Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 firstname.lastname@example.org Event link https://www.onlinecompliancepanel.com/webinar/Applying-Global-Standards-to-Life-Sciences-Compliance-Documentation-504874/AUGUST-2018-ES-TRAININGREGISTRY
Understand the validation and regulatory requirements for the sterile filtration of pharmaceutical products. Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 email@example.com Event link https://www.onlinecompliancepanel.com/webinar/Sterile-Filtration-of-Pharmaceutical-Products-Validation-and-Regulatory-Requirements-502453/AUGUST-2018-ES-TRAININGREGISTRY
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.
A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc. This webinar will analyze each of these necessary elements of the batch record review process.
Spreadsheets such as Excel, are available for creating a wide range of end user applications, including widespread use in the laboratory, creating customized statistical analyses, the creation of local databases, data mining, and multivariate analysis. These may be used for GxP regulated activities, and they present particular compliance challenges, as Excel and other spreadsheets are not originally designed for the regulated environment.
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented.Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.
To work with these challenges, it is essential to understand human behavior and the psychology of error as well as understand exactly where the weaknesses of the system are so that they can be improved and/or fixed. This course offers practical approaches and models to address human performance issues in GMP related environments by using a particular methodology to correct, prevent and avoid reoccurrence of these matters.
This webinar will review the QSR and ISO requirements for document control, and provide a streamlined process for document control.
Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 firstname.lastname@example.org Event link https://www.onlinecompliancepanel.com/webinar/Effective-Records-Management-Document-Control-for-Medical-Devices-505756/AUGUST-2018-ES-TRAININGREGISTRY
This 3-hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.
Discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection.
Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 email@example.com Event link https://www.onlinecompliancepanel.com/webinar/The-FDA-Inspection-Process-From-SOP-to-483-506420/AUGUST-2018-ES-TRAININGREGISTRY
FDA and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of import information and adherence to government procedures. Firms that fail to understand and properly execute an import and export program find their shipments delayed, detained or refused. As of December 2016, FDA and CBP officially implemented the Automated Commercial Environment (ACE) entry filing system. You either meet ACE requirements or face entry refusals and monetary penalties of up to $10,000 per offense.