Pharmaceutical Regulatory Compliance Training - Live Webinars, Recordings & CDs

Attendees will learn the FDA expectations when investigating out-of-specification and out-of-trend laboratory results.

This webinar will include a detailed discussion of Contract Manufacturing Organizations (CMO) Quality Agreement topics such as change control, documentation, facilities and equipment, lab controls, sub-contracting, etc. Attendees will learn how to comply with new FDA and EU guidelines for contract drug manufacturers.

Data integrity has been the subject of increasing scrutiny during pharmaceutical regulatory inspections in recent years. Chromatographic data systems have received particular attention because of the potential for data manipulation to produce fraudulent data or uncontrolled changes in processing parameters that compromise the comparability of results between runs. This webinar explains the intention behind data integrity regulations, sets out current expectations and suggests an approach to compliance based on sound science.

In this analytical method transfer webinar attendees will learn the options available for the transfer of validated, non-compendial methods to a different site. In addition to current regulatory guidance, the different options for method transfer will be discussed. The webinar will set out an efficient, risk-based approach that reduces effort whilst meeting the requirements of regulators.

The objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices.

This training will review the dietary supplement regulations in the USA and explain how to verify that your products are compliant with the most recent regulations and provisions. It covers the FDA regulatory structure and considerations for manufacturing, labeling and advertising dietary supplements.

This training program will discuss the types of human error, the taxonomy of human error, human error reduction initiatives, individual performance, cognitive load and human error, cognitive load categories, and more.

FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.

This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.

This training program will offer attendees an understanding of human errors in GMP related environments, factors and causes, and control measures to be put in place to reduce the same.

Attend this course to gain practical approaches for supervision on the floor, strategies to get your group in sync and approach issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues.

This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.

Attend this webinar to understand the Clean Room regulations, design, classification, sources and types of particles. Learn how to create a common ground between these varying regulations and requirements. It will discuss the types of micro-organisms, routine monitoring processes, and typical mitigation steps to effective contamination control.

This webinar will discuss how root cause is an essential part of a corrective action system and will provide some examples of how to perform root cause analysis.

In this pharmaceutical water system webinar attendees will learn how to design, validate and maintain the new and existing water systems used in drug product manufacturing process. Different types of routine tests, testing frequencies, actions in each tests and sampling procedures associated with pharmaceutical water systems will be discussed to avoid any water systems failures.

This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.