FDA Compliance
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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 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 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... -
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... -
Additive / 3D Printing Manufacturing and Its Regulatory Issues
Additive Manufacturing (AM) or 3D Printing for manufacturing of medical devices is a new and rapidly expanding field, with rapidly expanding regulatory concerns. What is it? What are US FDA stated concerns? This webinar will focus on the key... -
Adequate 510(k) Preparation Could Save Significant Resources – Dos and Don’ts
This seminar is intended to help medical device industry exercise best judgment when preparing for premarket notification for submission to the FDA. This webinar will provide great opportunities to get familiar with FDA policy and guidelines on how... -
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... -
Advertising and Promotional Material Compliance and Review Process
The webinar will address requirements for compliance, “gray areas,” risk assessment, opportunities for input from regulatory agencies, and review process and procedures. This webinar will address issues of compliance in the creation of advertising and promotional materials and the... -
Analytical Method Transfer According to USP General Chapter-1224
This webinar presents a logical, risk-based approach to method transfer based on existing knowledge of method characteristics and effective transfer documentation. The transfer of analytical methods is an important element in the lifecycle management of active pharmaceutical ingredients and... -
Analytical Method Validation and Transfer
This course provides guidance on how to perform QC analytical test method validations and transfers. One of the most critical factors in developing and marketing pharmaceutical drug substances and drug products is ensuring that the analytical methods used for... -
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,... -
Analytical Microbiology – Contract Lab vs In-House Lab – How to Overcome the Corporate Dilemma
Retaining analytical support in-house or using a contract laboratory is a corporate decision that should not be based on cost alone. This session will address factors that food companies need to consider before making decisions on outsourcing analytical food...
