Food, Drugs & Biologics
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510(k) Third Party Review Program – Latest Guidance, Changes, Challenges, and Opportunities
This webinar will examine the FDA’s latest draft guidance, “510(k) Third Party Review Program, Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations” and the important areas for regulated companies to focus in the... -
510(k) Update – How to Format Succinct and Comprehensive 510(k)s – 3 Hours Virtual Seminar
This seminar will discuss what to consider and how to prepare for premarket notification 510(k)s and submit to the FDA. The speaker will walk you through how to format a succinct and comprehensive 510(k) package to increase submission quality... -
6-Hour Virtual Seminar on Adaptive Design for Clinical Trials
Duration: 6 Hours
Presenter: Elaine Eisenbeisz -
6-Hour Virtual Seminar on Annual Product Quality Reviews – Preparation, Reports, Impact of Latest Quality Metrics Guidance
Product Quality Review and Annual Product Review are the favorite documents for the inspectors and QPs. This pandemic is impacted on auditing also. Many regulatory agencies are planning audits based on risk-based approach. The Annual Product Quality Review (APQR)... -
6-Hour Virtual Seminar on Biostatistics for the Non-Statistician
Statistics is a useful decision making tool in the clinical research arena. When working in a field where a p-value can determine the next steps on development of a drug or procedure, it is imperative that decision makers understand... -
6-Hour Virtual Seminar on Good Clinical Data Management Practices
Clinical data management (CDM) is paramount for a successful research. After all, Garbage In, Garbage Out (GIGO). CDM involves all aspects of collecting, processing, and interpreting information. There are many types of computer applications and database systems to support... -
6-Hour Virtual Seminar on GxP and the Quality System
GxP is the heart and soul of how we do business in regulated industries. GxP is a general abbreviation for the “good practice” quality guidelines and regulations. The “x” in the term stands for the various aspects of good... -
6-Hour Virtual Seminar on Introductory Pharmacology for Non-Clinical Professionals
This course is designed to introduce basic pharmacology concepts which are utilized in drug development and clinical research to non-clinical professionals. Topics will include the basic principles of pharmacology and overview of several major classes of therapeutic agents, with... -
6-Hour Virtual Seminar on Project Management for Non-Project Managers
This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject. It... -
6-Hour Virtual Seminar on Project Management in Clinical Research
This course is an integrative learning experience, combining a comprehensive review of the good clinical practice core principles and project management strategies applicable to clinical research during the new drug development process. This course examines the concepts and applied... -
6-Hour Virtual Seminar on QbD and Technology Transfer Program – A Practical Approach to Successful Implementation
This training will explain the main principles behind a QbD approach and provide guidelines in how to implement the concepts into a pharmaceutical development organization. Quality needs to be built in to the product at design stage. So, we... -
6-Hour Virtual Seminar on Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Systems for Regulated Industries
Pharmaceutical and Biotech laboratories use a multiple array of various gadgets, devices, analytical instruments and computerized systems on a daily basis. Qualification of equipment or ancillary systems are necessary to prove that all critical requirements work as intended and... -
6-Hour Virtual Seminar on Statistics for Process Control
This 6-hour virtual seminar includes a presentation of the steps and techniques used to quantify variability in manufacturing processes, and to assure quality products. The concepts and information presented will be mainly concerned with statistical process control: obtaining monitoring... -
6-Hour Virtual Seminar on Statistics for Quality Control
This 6-hour virtual seminar includes a presentation of the steps and techniques used to quantify variability in manufacturing processes, and to assure quality products. The concepts and information presented will be mainly concerned with statistical quality control: obtaining information... -
A Bulletproof, Cost-Efficient Supplier Management Program
A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures. Since FDA cannot regulate component suppliers, it is imperative that your company’s purchasing and supplier control requirements provide the assurance... -
Achieving Compliance Excellence through effective Training, Documentation and Management
This workshop will describe the environment in which success can be fostered with the tools that you already have at your fingertips – compliance documentation, training, and management structure. An effective model of human performance will be described and...
