GMP: Food Manufacturing for Professionals (21 CFR Part 117)

Demonstrate your commitment to compliance, safety, and professional excellence by achieving a distinguished industry certification.

Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com
Outline/Syllabus: See individual course pages for outlines.

Description:

GMP: Food Manufacturing for Professionals (21 CFR Part 117)

Master the essential principles of current Good Manufacturing Practices (cGMP) for the food industry and take your compliance knowledge to the next level! This comprehensive training program is designed for food manufacturing professionals who want to ensure their operations meet the highest quality and safety standards as required by 21 CFR Part 117.

Formerly outlined in 21 CFR Part 110, today's updated GMP regulations under Part 117 reflect the latest advancements in food safety practices and compliance requirements. Through this engaging program, you'll gain practical knowledge, historical context, and actionable strategies to implement and maintain cGMP across your organization.

This program consists of three (3) specialized courses:

• 1) GMP Awareness: Food Manufacturing - Begin with a deep dive into the Food Safety Modernization Act (FSMA), the most significant update to U.S. food safety laws since 1938. Explore the origins and evolution of cGMP, discover the six key reasons compliance is critical for food quality and safety, and learn the nine principles that form the foundation for implementing GMP in any food manufacturing facility. Includes a knowledge assessment to validate your learning.
• 2) GMP: Food Manufacturing Warning Letters and Case Studies - Understand what happens when the FDA issues a Warning Letter to a manufacturer. Analyze real-world case studies to see why violations occur, how companies must respond, and the importance of robust corrective actions. Learn how FDA audits can be leveraged as opportunities to strengthen your compliance program and protect public health.
• 3) GMP for Food Manufacturing: The Nine Principles (21 CFR Part 117) - Gain a detailed understanding of the nine core principles that guide cGMP implementation in the food industry, as defined in Subpart B of 21 CFR Part 117:
• Personnel (21 CFR Part 117.10)
• Plant and Grounds (21 CFR Part 117.20)
• Sanitary Operations (21 CFR Part 117.35)
• Sanitary Facilities and Controls (21 CFR Part 117.37)
• Equipment and Utensils (21 CFR Part 117.40)
• Processes and Controls (21 CFR Part 117.80)
• Warehousing and Distribution (21 CFR Part 117.93)
• Human Food By-products as Animal Feed (21 CFR Part 117.95)
• Defect Action Levels (21 CFR Part 117.110)

By the end of this program, you will:

• Understand the full scope and importance of cGMP in food manufacturing.
• Be able to apply the nine principles of GMP in real-world settings.
• Recognize the significance of FDA inspections and the consequences of non-compliance.
• Learn from real case studies to strengthen your preventive controls.
• Be prepared to maintain compliance and safeguard public health.

This is your opportunity to not only meet regulatory requirements but also elevate your role as a food safety leader in your organization.

Take the next step in your professional growth and earn an industry-recognized certification from Biopharma Institute -designed for professionals who want to excel in ensuring the safety and effectiveness of medicinal products.

These programs not only give you up-to-date regulatory and compliance insights but also deliver practical skills that employers value. Whether you're enhancing your current role or preparing for a new opportunity, Biopharma Institute certifications are designed to set you apart in the competitive and highly regulated pharmaceutical industry.

This program includes these 3 courses:

(Click on course links below to see outline/syllabus)

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	Individual Course w/Certificate of Completion: GMP Awareness: Food Manufacturing Enroll Here  Learn More Course ID: GMPF01 Duration: 20 minutes Price: Included
	Individual Course w/Certificate of Completion: GMP: Food Manufacturing Warning Letters and Case Studies Enroll Here  Learn More Course ID: GMPF02 Duration: 20 minutes Price: Included
	Individual Course w/Certificate of Completion: GMP for Food Manufacturing: The Nine (9) Principles of 21 CFR Part 117 Enroll Here  Learn More Course ID: GMPF03 Duration: 35 minutes Price: Included

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Additional Information:

Certification Requirements: To earn a certificate, students must complete the entire program and pass an online, multiple-choice final assessment for each course within 12 months of enrollment. Once these requirements are met, a certificate of completion is instantly available in PDF format.

Biopharma Institute's online training offers immediate access upon enrollment. Students receive their username, password, and instructions by email right after registration. The final assessment may be attempted as many times as necessary to achieve a passing score.

When all training requirements are fulfilled, a professional certification is awarded and can be verified instantly on our website using the unique ID code printed on the certificate. The certificate is issued in encrypted PDF format, featuring a watermark, unique validation code, and QR verification barcode. In addition, a digital badge is provided, documenting all completed courses within the program. Digital badges can be displayed on platforms such as LinkedIn, Facebook, Badgr, and other networking sites to showcase achievements.

Certificates and digital badges include the completion date but do not display an expiration date. Compliance training is generally considered valid for up to three years, and many organizations schedule refresher training every one to three years to maintain alignment with evolving regulations, standards, and GxP expectations. Biopharma Institute does not assign a universal expiration date as it recognizes that the validity period or recertification interval for each individual worker should be determined by each individual organization's quality management team.

Benefits of Being Certified by Biopharma Institute: Biopharma Institute's training engages students in active learning through interactive eLearning modules validated by independent third parties for relevance, regulatory accuracy, and compliance. Courses are developed by subject matter experts (SMEs) and instructional design professionals to maximize knowledge retention. Programs include access to regulatory references, real-world case studies, and other essential resources to support learning.

Since 2003, Biopharma Institute has supported professionals and employers in meeting their training requirements. Our certifications are recognized across industries, regulatory bodies, and organizations worldwide. Training solutions can be customized to meet the unique needs of any organization. We offer over 300 courses covering clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity for the clinical research, pharmaceutical, and medical device sectors.

Employee / Corporate Training: For organizations seeking cost-effective employee training without the need for travel, webinars, or in-person sessions, Biopharma Institute is the trusted training partner. Our programs deliver effective, engaging, self-paced learning that fits seamlessly into employees' daily routines. All eLearning modules are SCORM-compliant and compatible with most corporate learning management systems (LMS).

We accommodate both small and large-scale training initiatives with the same commitment- to create a positive, streamlined experience for everyone involved, from students to training managers.