In this webinar attendees will learn which products qualify for submissions under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act (FD & C) and the requirements for studies, reference information, and marketing requirements to take advantage of this great sponsorship opportunity.
In this FDA Inspection webinar attendees will learn about the FDA inspection process & the effective techniques how you and others behave and interact with FDA inspectors during an FDA Establishment Inspections.
This training on using the QbD approach to analytical method lifecycle is designed to provide participants with a lifecycle approach to developing and validating analytical methods and comply with compendial requirements. The webinar presenter will use case studies to illustrate each stage in the process.
This training program will highlight key differences between SDTM and ADaM models and process flows. It will also focus on key differences between the seven CDISC classes and on best practices to create Dataset.XML from SAS. Attendees will gain a better understanding of the structure and syntax of ODM-XML files as well.
This Webinar will help you how to ensure that your data and supporting documentation are in the appropriate format to comply with regulatory authority inspection. Risk based monitoring can contribute to better oversight and more efficient use of resources of clinical studies.
This E/M Auditing webinar will explain how to get start with an auditing program in your healthcare organization and expand your knowledge of evaluation and management coding and auditing that will help you to increase revenues, decrease denials, rejects, and assist your organization in being compliant.
In this training program, attendees will learn quick formatting tips that will make writing more readable and learn how to use formatting tools in a way to maximize the impact of their writing in an electronic system.
This training on using certified reference material in analytical laboratories will cover FDA and international requirements for selection, purchasing, testing, storage and use of (certified) reference material.
This webinar will discuss the steps to guide the technology transfer for the successful implementation, ensures that products of the highest quality are delivered to the patients along with meeting the business demands of the company.
This webinar on avoiding serious FDA 483s will explain FDA's changed audit focus based on recent top 483 findings and provide practical tips on how to better prepare your company's internal audit program to avoid serious Form 483 observations.
In this healthcare compliance webinar attendees will understand the role of the hospitalist, the hospitalist group and the collaboration responsibility with the case management department to ensure compliance with federal regulations, decreasing length of stay, and methods to improve case management outcomes.
This Medical device training will acquaint one with the various terms used in risk management and the importance of ISO 14971 & ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture.
This 60-minute webinar will cover principles and provide examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. It will provide you with the knowledge and understanding needed to improve patient safety and also to prepare your organization for regulatory inspections.
This webinar will focus on GMO (Genetically Modified Organism) Labeling and National Bioengineered Food Disclosure Rule (National Bioengineered Food Disclosure Standards Act). Definitions of foods subject to the ruling, exclusions, responsible parties, mandatory disclosure options, recordkeeping and implementation dates will be covered in this session.
In this regulatory inspection webinar attendees will learn the importance of developing and submitting a robust, timely response to FDA 483 observations or warning letters; as well as, educate the audience on the essential elements of a thorough response. Also attendees will learn the proper structure of the response to ensure the regulatory agency’s expectations are met and the submission process is properly understood.
This 2-hr laboratory inspection webinar will discuss strategies to implement before your laboratory is about to undergo a pre-approval inspection or a general GMP inspection. It will help you gain an understanding of the key areas that are likely to be the subject of a laboratory inspection.
This training program on applicable regulations pertaining to clean room environmental monitoring (EM) programs will discuss the basics of setting a robust and effective EM program. The course will also detail the relationship between an EM Excursion Program and CAPA and the four phases of clean room transitional monitoring.
This training program will discuss in detail the CMS requirements for hospitals to help prevent the hospital from being found out of compliance with the grievance regulations. It will also cover a new law under the OCR Section 1557 which requires the hospital to have a new process for handling discrimination complaints.
Cloud computing has become perhaps the most critical compliance topic related to computer validation and electronic records. The potential economic and resource advantages to using cloud based environments guarantee that management will expect compliance strategies to be developed that will support decisions to utilize cloud environments to perform regulated activities. This presentation will provide a baseline of information related to cloud computing which will help attendees better understand the cloud concept, associated regulatory challenges, and suggestions for consideration when establishing a cloud based system.
