Duration of course: Two days training course

Number of participants: Max 25 Participants

Registration: Kindly click to register for the event.

Who Should Attend?

This course is designed for individuals who are involved in ensuring regulatory compliance of drugs requiring in-depth knowledge of regulatory affairs and compliance issues.

Typical attendees include those in manufacturing, regulatory affairs, product design, research and development, quality assurance, development and preparation of submission material and laboratory operations.

When delivered as an in-house program, this course is fully customizable to meet the specific needs of an organization, department or employees' functional responsibility.

Learning Objectives

This course will provide each attendee with:

• The background and knowledge necessary to understand the organization, structure and role of the FDA as it relates to pre-marketing approval processes and compliance issues for medications
• Information on the paths to obtaining agency approval
• The understanding of how the FDA performs inspections
• An insight on the type of information FDA is looking to see in place and the variety of outcomes from each inspection
• The remedies available to satisfy inspectors that manufacturing processes are fully in compliance with quality system requirements

Training Focus

This course is specifically focusing on the law, regulations and policies set down by the FDA for the manufacture of pharmaceuticals. It discusses the Agency’s regulatory authority for approving drugs prior to marketing. It also provides an understanding of FDA strategies towards inspections of manufacturing sites and compliance actions that may result from these. The various regulatory processes are presented including the major enforcement tools such as warning letter, injunctions and civil money penalties. The course provides the attendees with the most important regulatory resource materials needed to understand the Agency behavior.

Issues to be covered include:

• Structure of the FDA
• Current FDA regulatory compliance practices
• How to work with FDA investigators
• The regulatory approval process – “what the FDA is looking for” in 510ks, PMAs and other pre-approval applications
• The scope of FDA’s compliance programs, policies and potential enforcement actions
• Discussion of post-marketing notification and reporting programs
• Strategies for development of an in-house compliance program for GMP and successful inspectional outcomes
• Recent FDA enforcement statistics

The course content is continually updated by our expert course directors according to the new regulations of the FDA.

About Your Expert Trainer and Certificate

Our expert trainers are joining us from the USA and/or Europe who are all highly qualified professionals referenced internationally. Upon the completion of the training, certificate of attendance and accreditation will be issued in the name of participant.