Dublin, July 25, 2023 (GLOBE NEWSWIRE) -- The "Raw Material Compliance in a cGMP Environment - Training on Issues & Solutions" training has been added to ResearchAndMarkets.com's offering.
This training focuses on the often overlooked aspect of product development - raw material requirements within a cGMP (Current Good Manufacturing Practice) environment. Understanding and complying with regulatory norms for raw materials is crucial to ensure that the final product meets FDA expectations and guidelines.
The training program emphasizes the significance of good manufacturing practices, highlighting that even minute elements like raw materials need critical attention to avoid receiving warning letters. By enrolling in this course, participants will gain a deep understanding of the intricacies of raw materials and their impact on the quality of the end product.
Course Overview
The course delves into various essential topics related to raw material compliance in a cGMP environment. It covers aspects such as the testing and approval of raw materials, criteria for component rejection, product container management, and closures. By learning these critical aspects, participants will be equipped to formulate representative samples effectively, release components and packaged products, prevent contamination, maintain sterility in equipment, and implement aseptic processing.
Moreover, the training imparts knowledge about the general criteria for testing and examining samples, the impact of multiple raw materials on the end product, and best practices required for commercial-grade manufacturing.
Frequently Asked Questions (FAQs)
Q1: Are there limitations on the number of raw materials a manufacturing unit can source as per raw material compliance? Answer: No, there is no fixed cap on the number of raw materials a manufacturing unit can source or procure. The inspection team focuses on ensuring that the individuals involved adhere to the relevant regulatory norms.
Q2: Does the course address the issue of minimizing pathogenic agent contamination in incoming raw materials? Answer: Yes, raw material compliance places a strong emphasis on avoiding contamination at every stage. Contaminated raw materials can significantly impact the purity and quality of the final product, and control strategies to prevent such issues are discussed in the seminar.
Q3: What are the steps involved before the release of raw materials as per raw material compliance in the cGMP environment? Answer: Before the release of raw materials, they must be stored in controlled conditions, segregated, and appropriately labeled as per regulatory norms. The materials also need to undergo testing and qualification before further use.
RAPS Certification:
The course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for up to 12 credits towards a participant's RAC (Regulatory Affairs Certification) recertification upon full completion.
Who Should Attend:
This training on raw material compliance is highly beneficial for professionals seeking to enhance their careers in the pharmaceutical and biotech manufacturing industry. The course provides valuable insights into cGMP violations, enabling attendees to build a better system for raw material procurement and processing. The following professionals stand to gain from this FDA compliance training:
- Regulatory and Compliance Professionals: Gain the ability to identify loopholes and develop better raw material procurement and processing systems.
- Manufacturing and Quality Engineers: Assess product quality internally, setting benchmarks to avoid warning letters and product recalls.
- Document Control Specialists: Learn to document raw material characteristics appropriately for future reference.
- Quality Auditors: Play a crucial role in product examination and provide critical feedback on the entire system.
- Project Managers: Understand basic regulations concerning raw materials, enabling suitable action and efficient product development.
Key Topics Covered:
Day 1
- Comparing and Contrasting FDA, Health Canada, ICH, USP, and EP requirements.
- Understanding the various raw materials and their impact on end-users.
- Assessing the impact of raw materials on timely product production.
- Exploring the single most used raw material in large molecule production and its impact on end-users.
- Understanding regulatory requirements for Phase 1 through commercial manufacturing.
- Utilizing additional testing methods and reviewing the Certificate of Analysis (C of A).
Day 2
- Exploring the use of compendial testing versus non-compendial testing - pros and cons.
- Managing regulatory risk (ICH Q9) associated with raw materials.
- Examining testing requirements, including sampling and testing techniques.
- Understanding the impact of Acceptable Quality Level (AQL) and the square root of N+1 on sample size and attribute testing.
- Applying the knowledge from the previous two days through case studies.
- Learning from warning letter examples.
Speakers:
The training will be conducted by Barry A. Friedman, Ph.D., a seasoned consultant with over 30 years of industrial managerial experience in biopharmaceuticals and medical devices. Dr. Friedman's expertise includes regulatory compliance, expert witness testimony, GLP/GMP, quality control, auditing, sterility assurance, microbiological/analytical validations, and fermentation technology.
Participants can benefit from Dr. Friedman's extensive experience in client management, raw material testing, environmental monitoring, and analytical chemistry for the production of biopharmaceuticals from bacteria, yeast, and mammalian cells.
Conclusion:
For those operating in the pharmaceutical and biotech manufacturing industry, understanding raw material compliance in a cGMP environment is of utmost importance to meet FDA guidelines and ensure the quality of the final product. This comprehensive training program offers valuable insights and best practices, empowering professionals to excel in their roles and build successful careers in the industry.
For more information about this training visit https://www.researchandmarkets.com/r/ix6zg6
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