This webinar will teach you how to conduct an effective management review of the quality system which helps you understand how to plan and focus on right metrics and governed by an efficient process. Participants will also understand FDA policy regarding disclosure of management review information during inspections.
This is a detailed course designed to provide medical device/pharmaceutical professionals with the information they need to prepare for and manage any type of FDA inspection. This course provides the rationale, strategies and flow on how to plan for an inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.
An ANDA is an Abbreviated New Drug Application. This application is submitted to the FDA to seek approval to produce a U.S. generic drug from an existing patented approved drug. The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs. After approval, the applicant is able to produce and market the generic drug product.
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.
This webinar will focus on regulatory requirements, optimal processes and define the difference in collaboration with both internal and external physician advisor roles. It will also discuss the role of the physician advisor and staffing needs to implement this important role.
Batch record review is an important step in the release of a medicinal product. This webinar sets out the regulatory requirements for batch records and sets out a systematic approach for review. Trending of batch data is also discussed.
This webinar will discuss what are Mycotoxins, classifications, contamination methods, the Regulations & Recommendations on Maximum Mycotoxin Levels, the risk management and prevention strategies to identify and control the contamination. You will learn the best agriculture practices, storage practices, dispatch and transport practices to prevent contamination.
This Webinar provides valuable assistance to all individuals who liaison with the FDA during inspections. It will also benefit senior management, who need to understand the methodologies used by FDA during inspections. During FDA inspections, several individuals from the organization work closely with FDA officials. For them and for senior management, understanding the intricacies of the methodologies used by the FDA is clearly of high importance.
The root cause of variable or inconsistent data from compendial dissolution tests can be difficult to identify. Formulation, equipment, operator error and incorrect calculation may be factors. This webinar presents a systematic, logical approach to investigating anomalous dissolution results.
FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit. It will also consider areas where FDA will likely focus their effort, including on the higher-risk systems. It will cover areas that will help you to plan for an on-site inspection.
This 2-hr webinar will review the FDA and FTC regulations for promoting and advertising dietary supplements, walk you through real-life case studies, help you address compliance, and tell you how to respond to an FDA enforcement action.
This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.
This training on lean documents and document control will explain the different types of documents and the usage of lean document principles. Attendees will also learn types of controlled documents; examples of lean and non-lean controlled documents, pros and cons of lean vs. non-lean documents.
This training will review the dietary supplement regulations in the USA and explain how to verify that your products are compliant with the most recent regulations and provisions. It covers the FDA regulatory structure and considerations for manufacturing, labeling and advertising dietary supplements.
Attend this webinar to learn the QSR and ISO requirements for supplier evaluation, including defining the types of suppliers that require evaluation, including “critical” suppliers and outsourced processes. The QSR and ISO requirements for supplier assessment will be defined as well. The webinar will discuss the application of a risk-based process resulting in a customized supplier management system.
FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit.
The FDA inspects facilities, online marketing collateral and physical products to determine compliance with the 21 CFR Part 111 dietary supplement regulations. It is very helpful to review their observations to infer what their priorities are and where industries and companies alike can improve.
In this webinar you will learn how to determine the Root Cause origin of a problem. You will learn a specific set of steps, with associated tools, to find the primary cause of the problem, so that you can prevent occurrences.
This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.
Attention Food Manufacturers, attend this webinar to learn latest FSMA based strategies to navigate the complexity under Prop 65. Prop 65 is an ever-changing regulatory arena, with complex requirements, frequent legal actions and strict labeling and notification regulations.
