All about GMPs

All about GMPs

Check out these info-packed sessions coming up at Engredea.

Course name: 21 CFR 111 Dietary Supplements Overview
Place: Anaheim Hilton Hotel
Time: 8 a.m. to 5 p.m.
Dates: March 7 to 8

This course provides attendees the tools necessary to successfully manage an inspection by the FDA. The FDA is actively auditing dietary all sizes of companies involved in the manufacturing, packaging, labeling, holding and distributing of dietary supplements.

Establishing a good reputation with the FDA takes a long time, and only one negative inspection can seriously damage that reputation. Ensuring the most positive outcome for your GMP inspection requires careful planning and preparation well before it occurs, successful management of many issues during the inspection itself, and thorough follow-up after the inspection.

This course provides real-world examples and utilizes classroom exercises that will take each participant through the different phases of an FDA audit, demonstrating tools and techniques for successfully managing an inspection.

Cost: $,1400
Speakers: Nicole Leitz

Register now!

Course name: Cleaning and Control Cross Contamination
Place: Anaheim Hilton Hotel
Time: 8 a.m. to 5 p.m.
Dates: March 7

Although Cleaning Validation is not required by 21 CFR 111, the principles applied in the pharmaceutical and biotech industry can be a useful tool to the dietary supplement industry to ensure the prevention of cross-contamination and potential adulteration. Therefore, the skills obtained in this course will ensure that cleaning methods implemented in your facility will prevent the potential carryover of product, cleaning agents, impurities and potential contamination of harmful agents.

Cost: $1,000.00
Speakers: Carlos Alvarez

Register now!

Course name: Batch Records Do’s and Don’ts
Place: Anaheim Hilton Hotel
Time: 8 a.m. to noon
Dates: March 8

Formal Master Manufacturing Records (MMRs) and Batch Production Records (BPRs) have long been required in the pharmaceutical world, but the new Good Manufacturing Practices for dietary supplements (21 CFR 111) bring these requirements to this industry as well. Deficiencies in MMRs and BPRs are among the most frequently cited during audits or inspections, including those from FDA. This course will examine common issues and pitfalls with MMRs and BPRs and provide specific guidance on how to avoid these problems. Best practices will also be highlighted to enable your batch records not only to withstand audits and inspections, but to streamline and improve your internal operations.

Cost: $800
Speakers: Carlos Alvarez

Register now!


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