All FDA Regulated Industry
Preparing a FDA 510(k) Submission
We will explain what a 510(k) is and the procedure to prepare the submission. The several types of 510(k) will be explained. Each part of the submission will be explained. The very confusing concepts of predicate device and substantial equivalence will be discussed. How to find an acceptable predicate device will be taught. FDA places special emphasis on-device software. we will cover the requirements for s..
Preventative Controls Approach for California’s Prop 65 for Food Industry
California’s Prop 65 enacted to inform its’ residents and workers the hazards associated chemicals and toxins that may cause harm has ballooned to over 900+ items, that industries must be aware of to operate within the state. The Food Industry has also been subject to Prop 65 legal battles on a host of products including French fries, chocolate, coffee, bakery products, candy and baby food that may now requ..
Proper Documentation and SOPs to Ensure Laboratory Compliance
This presentation will review the regulations, citations, and typical procedures found in laboratory operations and then propose a way to build better documentation.What laboratory documentation is required for complianceWhat are typical citations as it relates to laboratory documentationWith forethought and design, good procedures are possible Good documentation and record integrity ensure good complianceA..
Purchasing Controls and Receiving Acceptance for Medical Devices
This webinar can help you understand your responsibilities in terms of Purchasing Controls enabling you to provide safe and effective products to your customers. Learn how to prevent quality and compliance problems by having a strong system for Purchasing Controls! This webinar will help you to understand the regulations and how you can translate them into an efficient and effective process for purchasing/ ..
QMS Quality Management System
Some regulatory guidelines mention the need of a QMS. But every company should have a library for its biggest asset – the knowledge of the employees. The reason to have a QMS is not to satisfy the regulators, but for any employee to find the reason for doing the work they should do and how it is connected to the rest of the company.Any of you who wants to do a good job needs to know the reasons, rules, and ..
Qualification and Control of Contract Manufacturers (CMO) Based on Practical Experience
CMO’s must be selected following a rigorous formalized procedure. This webinar will describe a compliant program based on regulatory requirements and the author’s personal experience in qualifying over 40 CMO’s in the medical device industry. The control of changes is one such topic that is complex. Lessons from practical experience show methods that will prevent a development program from becoming uncompli..
Qualification of Suppliers and Contract Manufacturing Organizations
Suppliers and CMO’s must be selected following a rigorous formalized procedure. This webinar will describe a compliant program based on regulatory requirements. Phases of supplier and CMO selection from initial telephone inquiry to the quality survey to qualification audit will be explained. The qualification audit will be described with key points to evaluate explained. How to deal with uncooperative suppl..
Quality Agreements For Contract Manufacturing Operations
It is important for contract manufacturing operations, whether they are in the cosmetic, drug, or device industries to have a Quality Agreement in place. This webinar will teach you what a Quality Agreement is, why you need a Quality Agreement, where and when Quality Agreements are needed, and who should prepare, review, and approve a Quality Agreement.Areas CoveredWhat is a Quality Agreement?What should be..
Quality Control for Analytical Materials used in Microbiology Laboratories
Many laboratories are unsure about which QC practices are needed and what criteria to use to assess the acceptability of the performance of analytical materials, to meet not only their requirements but also to meet the requirements of ISO/IEC 17025. During this webinar, we will discuss a practical QC approach for in-house prepared and/or commercially purchased media, test kits, and reagents specifically app..
Quality Risk Management Overview
Per ICH Q10 Quality risk management is integral to an effective pharmaceutical quality system. It can provide a proactive approach to identifying, scientifically evaluating, and controlling potential risks to quality. However, integrating the principles of QRM into our quality processes is complex especially in a pharmaceutical organization. There is much confusion on how to define risk and individuals ofte..
Quality System Management Effectiveness
Quality management training will cover principles of QMS that will help your organization implement a QMS that is repeatable and efficient. A good QMS consists of standards and guidelines relating to their everyday business practices including but not limited to policies/procedures (or a Quality Manual), SOPs, and Work Instructions.It’s the common, centralized culture of quality that many people struggle wi..
Regulatory Affairs Project Management
This program will address approaches to regulatory affairs project management for clinical trial applications, marketing authorization applications, and ongoing management of regulatory obligations. The information obtained will enable effective management and tracking of time and resources to complete the project objectives and ensure regulatory compliance.Learning ObjectivesSetting tasks focused on projec..
Review of Chemistry, Manufacturing and Controls (CMC) of an Investigational New Drug Application (IND)
This webinar is designed to help pharma companies through the various key aspects of the Chemistry Manufacturing and Controls (CMC) information expected by FDA in an IND (Investigational New Drug) Application. The presentation will cover the key aspects of CMC package. And will explore the individual requirements across both the Drug Substance as well as the Drug Product sections of the CMC package.Learning..
Risk Based Environmental Monitoring
Environmental Monitoring (EM) programs for pharmaceutical manufacturing are evolving to a risk-based approach. The use of sampling data for the identification and mitigation of risk becomes a critical element in this process. No longer is it enough to utilize data for reactive excursion reporting.This presentation will discuss how to establish a risk-based Environmental Monitoring Program. During this sessi..
Sample Size Selection: Is That Number Right?
Mr. Yuval Shapiro shall review the basic statistics that are behind the Sample Size selection. Explanations on how to select samples for the Design (verification and validation) phase, and for the Production phase. Also, explanations on how to use the ISO2859-1 for simple cases at production shall be provided. Selection of the correct sample size is a challenging task, especially, when regulatory authorit..