Good Manufacturing Practices Regulatory Compliance Training - Live Webinars, Recordings & CDs

This training program will help you better manage projects and offer practical tools to understand data content and quality. Attendees will learn to apply validation methods to reduce time to validate clinical summary tables. Attendees will also learn to apply advanced SAS programming techniques to standardize and automate the validation process.

This training program will focus on creating a workable and effective records and information policy. It will also discuss establishing records and information management responsibilities, determining the locations of all information resources, planning long term archiving, and content and records management software considerations and options.

This training program will give you the foundational tools necessary to identify changes that need to be made while renovating existing manufacturing space, formulate a concise implementation plan that includes compliance protocols, and allows for continuous improvement.

This training program will analyze the general considerations for cGMP compliance and review the cGMP requirements in 21 CFR 4.4(b). The program will also discuss applications of cGMP requirements for specific types of combination products.

This training program will examine the many facets of disposable bioprocessing systems that incorporate a wide scope of polymeric single-use products. Single-use disposable technologies, from upstream to downstream processes, will be reviewed as related to the use of polymeric devices. Specific attention will be given to the related applications used in the production of biopharmaceuticals and pharmaceuticals.

The parallel requirements for medical devices and pharmaceuticals are incorporated into this comprehensive webinar that delineates the foundation for technology transfer and validation, encompassing regulatory requirements and voluntary guidance.

This training program will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. This webinar will focus on how to avoid the pitfalls that may occur during FDA inspections and help eliminate 483 observations. Attendees will learn how to identify and avoid potential pitfalls during deviation investigations.

This training program will assist anyone directly or indirectly responsible for the creation, content or validation of SDTMs, ADaMs, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. It will help attendees in determining how well your company is positioned to defend your FDA submission.

This training program will dispel mistaken paradigms regarding the risk based approach to introduction of rapid microbial detection systems for water systems. Attendees will understand how to validate and transfer LIF method and how to validate LIF instrument against currently used methods.

This training program will explore the ABCs of facilities enhancement – compliance-driven actions that get results. It will also discuss devising and implementing a bullet-proof plan to reach goals, set expectations, and lower costs.

This training program will offer participants an understanding of the concept of E&L (Extractables and Leachables) studies and about developing an E&L study in a reasonable and pragmatic way - based on regulatory requirements, guidelines and recommendations.

This training program will discuss fundamentals of infection and the use of materials/drugs to fight infection, FDA regulatory approvals for drugs and materials used to fight infection, and future thoughts on approaches to fight infection.

The objective of this virtual training seminar is to assist attendees in understanding and being able to apply FDA regulations for OTC drugs and to label and market them successfully in the U.S. while avoiding regulatory problems. The program will also explore other verticals such as: OTC drug monographs and their importance to product marketing, a summary of OTC drug GMP regulations, FDA rules for adverse event reporting of OTC drugs, avoiding FDA Warning Letters, and more.

This training program will explore why planning and implementing an information management solution can be a daunting task. Composing policies and procedures is a good start, followed by testing in small groups. But a lot of people are resistant to changing their work practices, especially if they have been working for an organization for a long time. The worst thing that can happen is that staff appears to be compliant with the new plan, but has found a way to continue their prior practices under the radar. The solution to this problem is a comprehensive initial and continuing educational plan.

This training program will discuss MHRA GMP data integrity definitions and guidance. It will also highlight the difference between intentional and unintentional failures of data integrity and examine how regulatory agencies detect data integrity problems.

This training program will provide tools require to understand what a good Request for Proposal (RFP) looks like, how to write one, and how the job of selecting a vendor becomes easy when these tools are employed.

This training program will discuss key terms and responsibilities related to FDA inspections and the purpose of the BIMO inspection program. It will also review the general purpose and overall process of an FDA inspection and enhance your inspection preparation strategies.

This training program will provide a review of the current testing requirements and discuss what happened to the old 87/91 LAL Guidance for Industry proposed guidance. The program will also discuss how to transition from one bacterial endotoxin test to another—understanding the RPT (Rabbit Pyrogen Test). Participants will also gain a clearer perspective of the Monocyte Activation Test (MAT).

This training program will provide attendees with the ultimate set of tools in order to help their firms properly create User Requirement Specifications (URS) for Computer Systems Validation (CSV) with emphasis on current industry trends in this particular area as well as current Food and Drug Administration (FDA) regulatory trends and enforcement activity.

Among other key topics, this training program will focus on what can be monitored in mixing operations, wet granulation operations, dry granulation operations, compaction operations, and coating operations.