Dietary Supplements in USA, 21 CFR Part 111 compliance

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経験内容

"With 20+ years of experience in the USA dietary supplement market, I help companies understand and meet the 21 CFR Part 111 regulations. I specialize in the creation and implementation of compliant systems and, through a practical, reality based approach, help companies reduce their regulatory risk. This includes but is not limited to:
- A wide breadth of experience including Part 111 and 117 compliance, Quality Systems, Product Development, Remediation, Consultation and Expert Witness (legal opinions)
Business & Employee Management
⋄ Staffing Requirements/Strategic Planning
⋄ Annual & Long Term Business Plans, 1 – 5 years projections
⋄ Risk Mitigation
Departments
⋄ Quality Assurance
⋄ Quality Control Lab
⋄ Product Development
⋄ Document Control
Domestic & International Markets
⋄ United States of America
⋄ Australia
⋄ Japan
⋄ EU member countries
Regulatory Compliance & Third Party Certifications
⋄ Part 111 (Dietary Supplements)
⋄ Part 117
⋄ TGA (Australia)
⋄ Kosher
⋄ NSF
Supplier Qualification
⋄ Audits
⋄ Real-Time Score Cards
⋄ (Dis)Qualification of Facilities & Products
⋄ Performance Improvement Plans
Harmonized Global Quality & Manufacturing Systems
⋄ Specifications (Components, WIP, Labels, Finished Product, Packaging, etc.)
⋄ Master Manufacturing Records (MMR) & Production Batch Records (BPR)
⋄ Investigation & CAPA
⋄ Change Control
⋄ Material Review Board (MRB)
⋄ Customer Complaint / (S)AER
⋄ Equipment Qualifications
⋄ Product Verification
Product Development
⋄ 2-Piece Capsule
⋄ Tablet (Coated, Chewable, Enteric)
⋄ Bulk Powder
Product Lines
⋄ Vitamins & Minerals
⋄ Herbal Extracts, Singles & Combos
⋄ Amino Acids
⋄ Probiotics
Database Design, Creation & Implementation (SQL & MS Access)
⋄ Controlled Documents & Training
⋄ Specifications & Allergens
⋄ Change Control
⋄ Supplement Facts Panels
Consultation & Remediation
⋄ SOP templates for Part 111 critical systems
⋄ Specification templates
⋄ Contract lab negotiations
⋄ GMP Training
⋄ Complian

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