Learn about the most overlooked aspect of product development i.e. raw material requirements in a cGMP environment. Starting from the role of water in determining the quality of product to the number of raw materials required - you’ll get thorough training on maintaining cGMP.
Introduction
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.
The training organizer has 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.
The organizer has come up with this detailed course on raw material compliance to understand the intricacy of an ingredient in a product.
Course Overview
Did you know more than 5,000 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
FAQs
Q1: Is there any fixed number of raw materials as per raw material compliance?
Answer: No. There is no cap on the number of raw materials a manufacturing unit can source or procure. Sometimes a small molecule might require up to 20 components while a larger biomolecule may need more than 60 components. At the end of the day, the inspection team only looks after the regulatory norms followed by the individuals.
Q2: Does the course focus on minimizing pathogenic agent contamination in incoming raw materials?
Answer: Yes. Raw material compliance emphasizes avoiding contamination at every stage. Since the purity of the raw material impacts the quality of the final product, control strategies are discussed in this seminar.
Q3: What are the different components before the release of raw materials as per raw material compliance in the cGMP environment?
Answer: Before the release of raw materials, they need to be stored in controlled conditions. Furthermore, they are segregated and labeled as per the norms. The final step is to test these materials and qualify them for further use.
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.
Please note: Only one Dial-in is allowed for 1-10 user price option and can be set up in a conference room.
Course Content
Day 1
- Compare and Contrast FDA, Health Canada, ICH, USP, and EP requirements
- The various raw materials and the user impact
- Impact of raw materials in the timely production of a product
- The impact of the single most used raw material in large molecule production and its impact on the user
- The regulatory requirements for Phase 1 through commercial manufacturing
- The use of additional testing - does one only review the C of A
Day 2
- The use of compendial testing instead of non-compendial testing - pros, and cons
- Regulatory risk (ICH Q9) with raw materials
- Testing requirements - how to sample
- Testing requirements - how to test
- The impact of ASQ and the square root of N+1 on sample size and attribute testing
- Case Studies - Time to apply the previous two days
- Warning Letter examples
Course Provider
Dr Barry A. Friedman, Ph.D,
Consultant ,
Cambrex Bio SciencesDr. 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.
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.
