Trial Master File (TMF) – Clinical Trial Systems and FDA Expectations

Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF). This webinar will help you understand in detail the new requirements for trial master files. You should attend this webinar if you are responsible for establishing or maintaining a TMF, or providing quality assurance for data included in the file. FDB3142 Areas Covered in the Session : Trial Master File (TMF) background and rationale Learn what content is required for a TMF for a clinical trial The essential documents to include in a TMF Understand how the essential documents demonstrate the conduct of the regulated activities of the investigator and sponsor Organizing and maintaining a TMF How to provide quality assurance for the data included Standard Operating Procedure required to support TMF Developing a consistent system for locating TMF documents Regulatory Inspection of TMF records and Preparation Industry Standards and Best Practices Interactive Q&A Session Who Should Attend: Lead CRAs CRA Managers Project and/or Study Managers Project and/or Clinical Trial Assistants Clinical Operations Administrators Quality Assurance Personnel Compliance Teams Validation Teams Sponsor and CRO personnel involved in set up, maintenance, and auditing of the Trial Master File for sponsors Consultants Teams involved with CSV Auditors engaged in the internal inspection of clinical trial documentation and practices


Advanced Auditing Strategies to Detect and Mitigate Data Integrity Risks

Any successful records management plan will start with a benchmark assessment of your current state followed by a data integrity audit. This training program will teach attendees best practices on how to perform audits for data integrity within their organization. Attendees will also learn how to centralize management and eliminate silos. Where are your records, what are the formats, how are they being tagged and classified, what kinds of policies are you applying to management and how well and consistently are you enforcing those policies? This webinar will help attendees learn how to apply consistent Meta tags and policies to all documents and records. It will also teach how to reduce compliance and e-discovery risks. This webinar is designed for people tasked with performing audits for their organizations for data integrity. It is also for those tasked with records management. This includes individuals that have Quality Management Systems responsibilities for making general improvements in their organization’s performance specifically related to equipment that produces and stores data, processes and documentation. Areas Covered in the Session : Establishing a Baseline Applying consistent meta tags to all documents Applying consistent policies to all records Achieving a best practice level of compliance Inspecting Live Computer Systems for Data Integrity Controls Pattern Recognition Methods Flags for Parallel Record-Keeping Evaluating Data Governance Programs Data Process Maps and Data Life Cycle Assessments Centralizing management and eliminating silos Evaluation of Current Enforcement Trends, including FDA & EU citations Reduce compliance and e-discovery risks Building a better business case Who Should Attend: Senior Quality Managers Quality Professionals Regulatory Professionals Compliance Professionals Production Supervisors Validation Engineers Manufacturing Engineers Production Engineers Design Engineers Process Owners Quality Engineers Quality Auditors Document Control Specialists


Best Practices for Having Successful Performance Discussions

How we talk about performance – how successful we are in doing this – is critical to the team relationships we forge and the effectiveness of team performance. Part of talking about performance is knowing how to have an effective performance discussion. The performance discussion is truly a collaborative process that we have – there must be an open exchange of views, ideas, and issues. The primary purpose of the discussion is to provide specific feedback concerning performance, to explain and gain mutual understanding of the ratings you have given, and to build a sound foundation for goal setting and development planning for the next year. Specifically, the purpose of the Collaborative Performance Discussion is: To provide feedback to the Team Member concerning performance To clarify for the Team Member individual strengths and areas needing development To discuss and gain mutual understanding of the ratings assigned and achieve closure To help the Team Member structure a Career Development Plan for the next year that will result in continued more effective and significant improved performance During this webinar, we will discuss some of the challenges of the Collaborative Performance Discussion, provide you with an opportunity to self-assess your discussion skills, and introduce you to the Coaching for Performance Model. Why You Should Attend: The primary reason for participating in this webinar is to ensure that you build effective collaborative relationships. For your management of team performance to be successful, you must overcome a number of critical challenges. Success in this case means that both you and your Team Member leave the discussion feeling that the process was fair, objective, helpful, and sets the stage for continued effective performance. Specifically, this webinar will help you to meet the challenges that you are facing including: Structuring a performance message that conveys a supportive tone, presents the evaluation in easy-to-understand terms, is fair and able to be supported and sustains a good working relationship Setting the stage for the discussion by creating a supportive environment Providing clear and relevant feedback Effectively handling disagreements when they arise Achieving mutual understanding of performance ratings, strengths, and development needs and achieving closure Areas Covered in the Session : Having a Collaborative Performance Discussion Challenges of the Collaborative Performance Discussion The Coaching for Performance Model Preparing for the discussion Providing Feedback Establish Mutual Understanding and Achieve Closure Who Should Attend: This webinar is suitable for professionals across all industries and functions. A must for all Directors, VP’s, Managers, Supervisors, Team Leads and everyone who may want to improve their ability to effectively manage performances.


Clinical Quality Auditing

As defined, Clinical Quality Audit is the process for improving the overall quality standard of clinical performances against the established standards. To evaluate trial conduct and compliance with SOPs, GCPs and the applicable regulatory requirements auditing needs to be independent of and separate from routine monitoring or quality control functions. It is paramount to incorporate a Quality Assurance component into your company’s Quality System. This is pivotal to ensuring that clinical research activities are conducted in compliance to applicable regulations. Auditing is used to verify and validate compliance. Clinical Auditing can be a great tool for discovering issues and rectifying them in ongoing research projects. Rather than have regulatory agencies inspection finding your studies were not conducted properly or in compliance, an audit is the preferred alternative. How do you conduct an effective audit will be reviewed in this webinar which will include preparation, auditing, documentation and follow up. This webinar will then move onto how to audit using Good Clinical Practice (GCPs) as the framework within clinical research no matter where the audit takes place including investigative sites, sponsors, or CROs. Finally the webinar will close with some information on latest trends in Clinical Quality Assurance. Areas Covered in the Session : General principles for auditing Steps for preparing and completing an audit Framework of using Good Clinical Practices Use of Tools and Processes Trends in Quality Assurance Who Should Attend: CEO’s Contract VP’s Quality Departments Regulatory Affairs Departments IT Departments Contract Personnel GxP Personnel Consultants


Analytical Method Validation under Good Laboratory Practices (GLPs)

Good Laboratory Practices training (GLP) is essential to any laboratory that supports products for sale or use in the United States. GLP much like GMP ensures a comprehensive system that guarantees validity of results and overall quality. Pharmaceuticals, chemicals, petrochemicals, and environmental analyses companies mandated to be following GLP training. A central aspect of GLP is validation of an analytical method. Completely new compounds are being developed each day in pharmaceuticals, structures that have never studied before by chemists. Their properties – such as solubility and acid-base nature, are unknown. Synthetic reactions may create similar types of molecules, including structural and optical isomers. The methodologies that warrant US FDA compliance with GLP regulations require being able to separate and identify all major, minor, and trace components. No longer is it just determining a purity of the main component, environmental analysis is a pre-requisite. As per GLP requirements, each minor contaminant or degradation product is also important. Why You Should Attend: This webinar will discuss analytical method validation and the best practices to follow, including components of a validation. We will also cover how to include critical reagents comparison, selectivity experiments, assessment of stability. The importance of communication between the development and the validation labs and accuracy of transfer documents (SOPs training) will also be addressed. Participants will be able to answer and understand – Is validation a regulated activity? Recognize when to pull the trigger for validation and the importance of suitability testing. Areas Covered in the Session : Method Validation The criteria for a method Statistical requirements Documentation requirements Maintaining Compliance Common issues Who Should Attend: Analysts Lab Supervisors and Managers QA Managers and Personnel Consultants Validation Specialists Chemists


Measurement, Analysis, and Improvement for safe and Effective Medical Devices

This 90 minute Webinar will cover the concepts of measurement, analysis, and improvement to ensure conformity of products, conformity of the management system, and on-going effectiveness. This webinar includes strategies to improve the efficiency of your Quality Management System (QMS) for medical device companies. An effective yet efficient quality system can be a competitive advantage for companies by leading to improved quality and compliance as well as optimizing the cost of quality. This webinar will get you started in setting up just such a Quality System. We’ll discuss techniques for improving efficiency, reducing burden, and still maintain an effective QMS. In this webinar, we will discuss: – Regulatory Expectations – Common problems and lessons from 483 and warning letters – Red-flags that your QS is not effective – Measurement and metrics – Feedback, Complaint Handling, Internal Audit – Analysis of data – Risk based thinking – Improvement and your CAPA process – Management Review Why You Should Attend: This webinar will help you understand regulatory requirements and how to translate them into a quality system that is both effective and efficient. You’ll learn to recognize sources of ineffectiveness and inefficiency in your QMS. This webinar can help you get your quality system off to a good start and avoid common problems including MDRs, recalls, 483s, and warning letters! The expectations for quality and compliance continue to increase. We will discuss changing regulations and expectations and what you can do to prepare for them. This seminar will allow you to interact personally with an industry expert with over 30 years’ experience in medical devices. Learning Objectives: Quality System Expectations Characteristics of an effective QMS Characteristics of an efficient QMS Roles, responsibilities, capabilities Red Flags and warning signs Improvement tools and techniques Inspection preparedness and management Best Practices Areas Covered in the Session : Establishing P&PC Change Control Environmental Control Personnel Requirements Contamination Control Buildings Equipment Manufacturing Material Automated Processes Inspection, Measuring, and Test Equipment Process Validation Linkages to the total product life cycle and risk management Process Improvement Who Should Attend: Quality Systems Specialists Document Control Specialists Quality and Compliance Specialists Auditors Auditor Managers Compliance Managers Quality Managers CAPA Specialists Quality and Compliance directors for Medical Device companies General Managers and Executives wanting to use Compliance and Quality as a competitive strength


Be Prepared for your next HIPAA Audit

Being in compliance with HIPAA involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place. If audited or the subject of a compliance review you will be required to show the government you have all the necessary documentation in place for safeguarding patient Protected Health Information and indicate how you addressed all required security safeguards. This starts with the understanding the fundamentals of a HIPAA compliance. If your healthcare practice, business, or organization needs to understand how to be prepared for a HIPAA audit and to make sure your current safeguards are adequate and can withstand government scrutiny, please join us for this informative and interactive course. Why should you Attend: Almost 120,000,000 individuals were affected by HIPAA data breaches. This is a significant reason why Congress has inquired about the recent and very sizeable increases in cyber-attacks that inflect the risk of medical identity theft. And with the Phase 2 Audit program underway, selected Covered Entities will soon receive written notifications they are going to be audited. Attendees will leave the course clearly understanding of all the requirements that must be in place for HIPAA and how to demonstrate compliance if audited. After completing this course, a Covered Entity or Business Associate will be able to know what needs to be place when it comes to all of the HIPAA regulations. Areas Covered in the Session : Why was HIPAA created? What are the HIPAA Security and Privacy Rules? What is a HIPAA Risk Management Plan? What is meant by “Required” and “Addressable” Implementation Specifications? What are Administrative, Technical, and Physical Safeguards Requirements? What is a HIPAA Risk Assessment? What are HIPAA training requirements? What is a HIPAA data breach and what happens if it occurs? What are the penalties and fines for non-compliance and how to avoid them? Preparing for a HIPAA Audit Creating a Culture of Compliance Interactive Q&A Session Who Will Benefit: Compliance Officer HIPAA Privacy Officer HIPAA Security Officer Medical/Dental Office Managers Practice Managers Information Systems Manager Chief Information Officer General Counsel/lawyer Practice Management Consultants Any Business Associates that accesses protected health information IT Companies that support Medical/Dental practices or other healthcare organizations


Behavior Health Coding and Documentation

Evaluation and Management codes are often vulnerable to third-party auditor scrutiny. Payers frequently use different types of analyses to identify outliers with E/M coding, such as physicians who bill higher-than-normal levels of more intensive codes. Other auditors, such as Recovery Auditors, Medicare Administrative Contractors, and Zone Program Integrity Contractors often follow the same process to use this same type of data to calculate from analytics. Given the increased scrutiny of these codes, it’s important to be confident with E/M and other coding that it is reflective of the accurate documentation during the patient encounter. During this webinar, we will revisit E/M coding guidelines and other top office services for Behavior Health professionals. There will be sample scenarios used during the webinar to help define the reason for the patient encounter documentation requirements that meet the definition of the code. Why You Should Attend: According to the CMS documentation audit tool, medical necessity is the overarching criterion in determining the level of service to bill, along with the individual requirements of a particular CPT code. It would not be appropriate to document and bill a higher level of service when a lower level of service is warranted. Nor should the volume of documentation be the primary influence for which level of E/M service is billed. Due to increasing audits with E/M coding and documentation, each provider should be asking the question, “Does my documentation truly justify the services rendered, and are those services medical necessary for the diagnosis treated? Areas Covered in the Session : E/M documentation guidelines Review all the key components of choosing the accurate code When is it appropriate to bill two types of CPT codes Meeting coding and documentation requirements for time-based psychotherapy services Key documentation points for supporting the code for Interactive Complexity Documentation focus and coding for Family therapy Medical record templates and medical necessity Sample Behavior Health scenarios used in presentation Who Should Attend: Physicians Billers/Coders for Behavior Health Compliance Officers