Duration of course: Two days training course

Number of participants: Max 25 Participants

Registration: Kindly click to register for the event.

Who Should Attend?

The course is designed for all scientists (managerial and laboratory) and professionals in biotechnology, biopharmaceutical, cosmetics, pharmaceutical and agrochemicals industries, whose job function necessitates the generation, evaluation and assurance of data.

It will benefit professionals who are new to the pharmaceutical industry and also those who need refresher training. This course is also useful for quality assurance and quality control managers, regulatory affairs professionals, auditors and production managers interested in effective compliance techniques.

Learning Objectives

Upon completion of this course, attendees will have an understanding of the various aspects of GMP regulations including:

• Attributes of materials, including formulation components, container and closure systems, labels and labeling, materials in process, and finished pharmaceuticals
• Methodology, including documentation, manufacturing validation, quality assurance, quality control, and supportive manufacturing operations
• Personnel and facilities, including building, equipment, instruments and infrastructure
• Analytical and laboratory validation and compliance programs
• The process of an FDA inspection and the compliance auditing process
• The concept of compliance; understanding the why behind the GMP regulations

Training Focus

Good Manufacturing Practice regulations (cGMPs) are used by pharmaceutical, medical device and food manufacturers as they produce and test products that people use (Drug cGMPs also apply to the veterinary drugs). This course explores the regulations through which the United States Food and Drug Administration (FDA) has issued as the minimum requirements controlling the drug, cosmetics and diagnostic industries. Major emphasis is placed on understanding the need for and the intent of regulations and developing mechanisms for implementation and compliance.

Participants are introduced the principles of GLP/GMP in the pharmaceutical and associated industries with the emphasis on the necessary procedures and documentation required to achieve full compliance.

This course is intended to give participants an introduction to cGMP regulations and their application to laboratory studies and manufacturing processes. It will also provide participants with an understanding of terminology and the role GMPs play in assuring their validity.

How will you benefit?

Employees must assure compliance with current Good Manufacturing Practice (cGMP) guidelines within their organization in all efforts aimed at generating regulated data. Hence, all participants will gain a fundamental understanding of the regulations, the necessity of implementing them rigorously. The ability to monitor compliance in their  organizations and incorporating this regimen in all scientific matters will be developed. Consequences of non-compliance will be examined.

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.