Biotechnology Documentation and IT Regulatory Compliance Training - Live Webinars, Recordings & CDs

Buying software is a fact of life for most companies. There is fierce competition in the market, with multiple software vendors trying to convince to buy their product. How do you determine whether to buy the software or having it built in house? Or which vendor to choose? And if you buy something, how do you determine whether to have it hosted? And are there any regulations that apply to this software? And if so, what are they?

This webinar will introduce attendees to key components of a computerized system validation master plan and set out the requirements for compliance as per FDA’s 21 CFR 11. It will detail several aspects such as requirements, design, configuration specifications, validation testing, procedures/archival/traceability, and best practices for system decommissioning/retirement as well.

This webinar will cover FDA’s current thinking on QRM and Guidance for Industry - Q9 Quality Risk Management, provide information to help understanding of QRM concepts, and applications. In addition, brief review of how ICH Q8, Q9, and Q10 work in coherence throughout product lifecycle.

This webinar will focus on most trustworthy open access resources. It will also provide tips on how to gain access to hard-to-find materials by paying high subscription or membership fees.

This webinar will provide an understanding of the organizational hierarchy of FDA and Health Canada, your regulatory and quality compliance obligations and the implications of the interactions between these two agencies on your organization.

When exporting outside the U.S., exporters must consider the Food and Drug Administration (FDA) provisions as it helps them understand what documents and procedures are needed in coordination with the transaction process. This training program will provide an in-depth explanation of FDA-regulated products that are exported from the United States to foreign countries. Also, it will address what export documentation must be used in the transportation of FDA-regulated products.

The webinar will describe application of SPC in manufacturing and QC and how to integrate SPC into the Quality System.

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 help the attendee gain an understanding of the requirements of current USP <85> Bacterial Endotoxin Test (BET), European Pharmacopoeia (Chapter 2.6.14) and the Japanese Pharmacopoeia (General Tests, No. 4.01). The webinar will provide the attendee the ability to understand the different LAL testing methodologies, choosing the best test method applicable to the product type, criticality of the BET test result as it applies to the release of a cGMP manufactured product.

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

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 address the daunting task of conveying complex technical data clearly, concisely, and purposefully to technical and non-expert audiences alike. Writing examples from diverse technical fields makes this webinar highly relevant. The program will build a foundation for learning by identifying the qualities of effective writing and the roadblocks to overcoming them.

This training program will provide professionals with essential elements of CAPA investigations to assure compliance with regulatory requirements. The corrective and preventive action (CAPA) program is an essential element of a compliant quality management system, as required by international regulations and voluntary standards. Investigations are the backbone of the CAPA program.

The webinar will discuss the current available regulatory pathways to develop FDA-regulated 3D printed products and also predictions on what to expect in the near future. 3D printing in personalized treatments will be discussed and attendees will be provided practical tips for pursuing approval with the FDA.

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.

This training program will provide attendees with an introduction to FDA’s veterinary drug approval process. It will also discuss key components of an appropriate animal field study needed to support new animal drug approval and explain how jurisdiction is split between various federal agencies in certain cases.

This webinar will discuss the FDA guidelines for handling unsolicited requests about off-label information. It will provide attendees a list of dos and don’ts related to social media techniques in off-label promotion.

This Validation training will give a good understanding on what the requirements are and how to validate laboratory computer systems in the most cost-effective way.