Biotech Regulatory Compliance Training - Live Webinars, Recordings & CDs

In this training program, attendees will learn how process robustness tools and metrics can be utilized to enhance process understanding and control. The new FDA paradigm is shifting to the expectation that organizations certified by other standards such as ISO and EFfCI demonstrate process robustness. It is the obligation of the primary pharmaceutical provider to ensure process robustness throughout the supply chain.

Attendees will come away from the training program with the tools they need to understand the various types of enclosures and how to select the correct type of enclosure for their process in order to meet regulations, protect the product, and ensure worker safety. The course is apt for personnel in FDA regulated industries who want to learn about what enclosure is best suited for their process and why.

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 training on auditing of software vendors for FDA compliance will explain the types of audit and its use in qualifying and selecting vendors. It will discuss sample forms and checklists which may be used by the participants for observations, recommendations and remediation.

This Clinical trial auditing training will provide valuable assistance how to conduct clinical trials both using internal resources and also those that outsource the function to CRO’s in pharmaceutical and biotech industries. How to assure your clinical trials are in compliance and meet the agencies requirements.

This contamination control training will focus on how to use the EM data appropriately as part of a contamination control plan and also discuss about Designing and Managing a Microbiological Monitoring Program.

This biotech training will provide valuable assistance to all regulated companies (Pharma, OTC etc) that manufacture non-sterile products.

This Water system compliance training/webinar focuses on the factors that can lead to water system sanitization success as well as failure so that the user can not only devise workable sanitization approaches.

This Water system compliance training will guide you through the changes to implement to Validate Water system and better understanding of quality specifications and process control levels, as well as the microbiology of water systems.

This Objectionable Microorganism training 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 Microbiology training/webinar will provide a new approach in ensuring the Microbiological Integrity of Pharmaceutical and Biopharmaceutical Facilities.

This water compliance training/webinar covers the reasons for diverse types of flora from one type of water to the next, the differences in the compendial water test methods, the advantages and disadvantages of harmonization.

This Spreadsheet validation training will cover the use of spreadsheets to report data from the inception of the spreadsheet (user requirement specification), through the development process, validation, and use.

This Water System Compliance training will review what biofilm is and how it grows and will cover how it affects just about every kind of unit operation used in today's water systems.

This FDA audit training will review the fundamental aspects of auditing biopharmaceutical API facilities to ensure their compliance with current regulatory guidelines.

This presentation will discuss the rationale for a process and offer suggestions including definitions and methods for documentation and communication. One of the most common inspection findings is a failure by the Investigator "…to conduct the studies or ensure they were conducted according to the investigational plans". Often, the citation isn't just that the protocol wasn't followed but that documentation surrounding management of the issue is insufficient. Therefore, Sponsors are well served by having an effective process to identify, document, and communicate departures from the investigational plan. This presentation will discuss the rationale for a process and offer suggestions including definitions and methods for documentation and communication.

This Biotech training will provide valuable assistance to all regulated companies that need to investigate product issues.

This Pharmaceutical compliance training will outline actions to take to ensure the microbiological wellness of your facility and will introduce the concept of "Thinking like a Bug".

This medical device training will guide you through Combination products and overview of clinical benefits, regulatory issues and manufacturing challenges. Medical products, no matter how well designed, can only do so much to address many of the clinical problems today. In order to tackle the clinical problems of the future, medical devices will be used in combination with drugs and biologics (called combination products) to treat a wide range of diseases from heart attack and stroke to Alzheimer’s and diabetes and beyond!