About us:
At ALCA Global Supplement Industry Consulting, we offer extensive real-world corporate experience, top credentials, and reliable and flexible Quality Assurance and auditing competence necessary to provide exceptional services and deliver timely results to our clients. We have performed many GMP audits and have ample familiarity in navigating the world of dietary supplement GMP regulations. Our seasoned professionals have helped many clients nationwide and also internationally to write and implement their entire Quality Management Systems (QMS) to help pave the way to successful audits and passing quality certification programs.
ALCA Global Supplement Industry Consulting offers customized solutions by personalizing our consulting services to your organization’s unique needs, circumstances, and challenges, always building quality throughout your entire process.
ALCA Global Supplement Industry Consulting offers continued support and commitment throughout the service by being fully accessible, and firmly believe in building lasting partnerships with our clients.
Simply put, ALCA Global Supplement Industry Consulting identifies problems and offers real solutions to your needs. You can trust ALCA Global Supplement Industry Consulting in providing you with the assurance that your GMP compliance needs will be met and be totally sustainable. Whether you are a brand, contract manufacturer, contract packager, or distribution center, ALCA Global Supplement Industry Consulting is here for you!
Mission:
To be your unparalleled ally in ensuring and maintaining the highest standards of Good Manufacturing Practice (GMP) compliance.
Credenciales:
Carlos Alvarez
President - ALCA Global Supplement Industry Consulting
To be a trusted global consulting company that best understands and satisfies the client’s GMP compliance needs promptly.
Vision:
My experience is very diverse and covers a wide spectrum of activities, including consulting, corporate engineering positions, and multi-level quality positions in the food, dietary supplements, pharmaceutical and biotech industries, from which I can extract the following core competencies:
* Quality Management Systems development and implementation
* Expert Auditing, Training and Consulting 21 CFR Part 111, 210/211
* International experience in Supply Chain Quality
* Quality Oversight of Contract Manufacturing Organizations
* Quality Assurance and GMP/USFDA compliance
* Process technology transfer and validation
* Team Leadership, Coaching, and Mentoring
* ASQ CQA and PCQI certified
• FSMA, HARPC expertise
• Held management and senior quality positions worldwide
• Fully bilingual (English/Spanish)
Range of Experience:
* Extensive NSF auditor, trainer, and consultant
* Inspections and developing/managing/promoting continuous quality improvement activities for employers
* GMP/regulatory knowledge
* Experience developing product quality systems/programs
* Commercial pharmaceutical and dietary supplement manufacturing plant experience ensuring quality oversight
* Experience managing customer and GMP certification audits, clients and regulatory inspectors
* Have taught 21 CFR 111 GMP classes at Supply Side West (SSW) for many years
* Have taught 21 CFR 111 GMP classes for private companies around the world (bilingual)
* Have represented companies as their consultant during FDA inspections
