cGMP Environment Raw Material Requirements (Health Canada/USP/EP) Issues and Solutions Training Course (ON-DEMAND) – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The

The World Compliance seminars team has come up with a detailed course on raw material compliance to understand the intricacy of an ingredient in a product. We have enforced the idea of good manufacturing practices through several pharmaceutical GMP training programs. However, minute elements like raw materials need critical attention to avoid warning letters.

Every biotech product is an amalgam of multiple raw materials that add purpose and efficiency to it. Since raw materials are the foundation of these products, it is important to have regulatory norms in place for them. Hence, this seminar discusses raw material compliance to ensure every final product meets FDA expectations and guidelines.

Course Overview

Did you know more than 5000 firms received the notice for not having cGMP-controlled raw materials? This is not a scenario you dream of while running a pharmaceutical and biotech manufacturing business.

As much as the cGMP course plays an essential role, concerned personnel needs to understand regulatory requirements for raw materials. The basic framework of this course is different from cGMP online training.

It includes topics like testing and approval of the raw materials, rejection criteria of components, product container management, and closures.

As far as the benefits of pharmaceutical cGMP training are concerned, you will learn the following things:

• Basic guidelines to formulate representative samples for effective testing and inspection
• Best practices to release each component, packaged product, and closures
• Appropriate techniques to collect samples alongside preventing contamination, maintaining sterility in equipment, and aseptic processing
• General criteria for testing and examination of the samples
• Impact of multiple raw materials on the end user
• Adhere to the best practices required for commercial-grade manufacturing
• In addition to these general topics, here are the topics that will be discussed in the seminar.

Who Should Attend:

Raw material compliance is currently the talk of the town and upskilling yourself will help you in building a positive career. Moreover, additional knowledge of cGMP violations will help you excel in the department.

Below are some professionals who will benefit from this FDA compliance training:

• Regulatory and Compliance Professionals: Develop the ability to identify loopholes and build a better system for raw material procurement and processing.
• Manufacturing and Quality Engineers: Assess the quality of the product internally and set a benchmark for the entire team to avoid warning letters and product recalls.
• Document Control Specialists: Gain perspective on documenting the characteristics of the raw material appropriately for future reference.
• Quality Auditors: In-house auditors play an essential role in product examination and are responsible for giving critical feedback on the entire system.
• Project Managers: The course will help them understand basic regulations related to raw materials so they can take suitable action and manage product development.

12.0 RAC CREDITS

RAPS – This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Speakers:

Barry A. Friedman, Ph.D

Consultant

Cambrex Bio Sciences

Dr. Friedman possesses over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness testimony, GLP/GMP, quality control, auditing, sterility assurance, microbiological/analytical validations and fermentation technology.

Prior to becoming an independent consultant, Dr. Friedman was associated with Cambrex Bio Sciences, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, Maryland. As the Director of Quality Control, he managed a multi-shift Department of thirty one individuals involved in client management, the receipt and testing of raw materials, environmental monitoring and microbiology, analytical chemistry and QC compliance for the production of Phase 1, 2, 3 and commercial products manufactured from bacteria, yeast and mammalian cells. In this capacity, Dr Friedman enjoyed many client and regulatory interactions, both domestic and international.

Prior to 2000, Dr. Friedman was the Laboratory Director for Chesapeake Biological Laboratories, a contract Aseptic Fill n’ Finish manufacturer located in Baltimore, Maryland. In addition to the professional history listed above, other associations have included W.R. Grace, Sigma Chemical Co., Sherwood Medical, Becton Dickinson, American Cyanamid and Union Carbide.

Dr. Friedman received his B.S. degree in Microbiology from Ohio State University, his M.S. from Michigan State University in Microbial Genetics, and his PhD from Ohio State University in Microbiology.

For more information about this training visit https://www.researchandmarkets.com/r/w04u4w

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