Biotechnology Regulations and Guidance Training - Live Webinars, Recordings & CDs

This webinar training will benefit manufacturers of manufactured products to achieve an effective, robust and compliant SOP and STM which will result in a cost effective and efficient manufacturing and testing of products. A well planned and written SOP or STM will reduce the incidence of out-of-specification (OOS) results, failure, product non-conformances, deviation and invalid assay investigations.

This webinar will discuss FDA's current priorities and the agency's likely priorities and the future of regulations and policies in 2017 under the new Trump administration.

This training course will provide a detailed overview of the regulatory requirements, local challenges and important cultural aspects of working with the lifecycle of life science products (pharmaceuticals, medical devices, biologics and combination products) as an importer or producer in Russia. It will offer a deeper understanding of cultural norms, and will discuss best practices for establishing relationships and protecting your intellectual property to be integrated into your company’s training and corporate business strategies.

This webinar on objectionable microorganisms will explore the most current practices that define an objectionable microorganism and will provide a practical approach to determining just how objectionable it really is.

This training program will discuss risk management and outline the requirements for applying risk management to the quality system. It will also discuss how to conduct and implement risk management practices at your firm and review communication techniques to highlight the benefits of risk management.

This webinar will review the CTD format and content requirements for the DMF. It will discuss the transition from other formats to the CTD/eCTD and technical requirements for eCTD submission.

This FDA documentation webinar will explain the regulatory expectations for, and the proper design and maintenance of effective and compliant standard operating procedures (SOPs).

This 4-hr webinar will focus on product lifecycle concepts that are applicable to all of the FDA regulated industries. Learn the objectives, purpose and scope of the quality manual and how to can be adapted to each different business environment.

This course will present attendees with a clear understanding of the new processes and requirements for EU sponsors of clinical trials as the new regulation is published, rolled-out and implemented by the Member States, the European Medicines Agency and the European Commission.

This webinar will focus on biological indicator usage for sterilization performance qualification in the pharmaceutical and biotech industry. Biological indicator preparation, including population and D-value resistance determination, is presented in depth. Understanding these details is critical to successfully choose a biological indicator and qualify a sterilization process.

This webinar will discuss the regulatory and GMP requirements for steam sterilization and the mechanism as it relates to bacterial cells and endospores. The training will cover autoclave performance qualification studies and the tools to be used.

This webinar training will examine the key topics concerning the use of polymeric single-use products in biopharm processes. It will offer a basic understanding of industry standards and regulatory compliance. The training program is designed for the experienced as well as those new to biopharmaceutical processes and need to know current requirements for determination of extractables and leachables in biopharm processes.

This training program will discuss formatting SOPs, FDA expectations for written documents and regulatory requirements, and the roles and responsibilities of authors and reviewers of SOPs. The program will also overview how to ensure a system for the control, archival, and disposal of written procedures.

This training program will offer an understanding of analytical method life cycle and regulatory expectations and requirements for the methods during product development. The webinar will also analyze risks and inherent variability of analytical methods.

This GMP inspections webinar will review what to expect during the agency inspection and how to successfully and efficiently streamline and manage the inspection, including adequate follow-up during and after the inspection.

This training program will highlight all the key areas that need to be under control or can lead to product recalls, product liability lawsuits, and the causes of these economic disasters for manufacturing corporations.

This training program will guide attendees in writing effective Standard Operating Procedures and Work Instructions. It will also discuss how to assess and write to the audience and how to review and revise SOPs and Work Instructions.

This CDISC training program will enumerate clinical data issues, effective methods and SAS macros to identify data issues, and communicating and monitoring improvements in clinical data issues.

This training program will illustrate how these two different concepts are integrated (Phase 1, 2, and 3 vs. Stages 1, 2, and 3) and where do they merge. Attendees will learn if they exist independently of each other or do they complement each other to enhance, build and provide a product.

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.