1. LB QUALITY CONSULTING
GMP AND REGULATORY COMPLIANCE CONSULTING FOR
THE DIETARY SUPPLEMENT INDUSTRY
L I S A B O N S I G N O R E
5 1 6 - 3 5 9 - 2 4 8 7
V A L L E Y S T R E A M , N Y

2. CAN A CONSULTANT ADD VALUE TO YOUR BUSINESS?
1. Don’t have the time or resources to manage all your Quality and Regulatory compliance requirements?
2. Can’t find time to leave the office to perform supplier audits?
3. Too many projects, not enough time in the day?
4. Questions about cGMP compliance, or food safety procedures within your facility or processes? Not sure what steps to
take next??
5. Trying to achieve GMP, HACCP or other certification(s) while juggling everyday compliance challenges?
6. Or just need assistance in handling a specific situation without diverting your employees time?
I CAN HELP ANSWER ALL OF THESE AND MORE!
I understand exactly how you feel, as I’ve been in the same position and struggled through the same challenges. After working in
the Natural Products industry for 20 years, I’ve already spent the time conquering the hurdles toward GMP and Food Safety
compliance, and built networks of professionals and resources throughout the industry. I come to you, not from “Big Pharma,”
but rather as someone who’s learned and mastered the industry’s rules, and could help devise a plan of action to best apply them
into your business model.
• In my career, I have brought two companies of vastly different sizes– one with global outreach, the other a smaller niche
domestic company– to a level of compliance to achieve USP DSVP certification and NSF certification respectively.
• On the other side, I have managed nationwide recalls without a hiccup and took lead in preparing responses to the FDA,
of which all were accepted first time around.
EFFECTIVENESS & EFFICIENCY
By focusing on improving the two “E’s,” I will help your team find the delicate balance of
achieving compliance AND achieving your business goals cohesively.

3. • Gap Assessment audit to determine company’s current state of compliance with cGMPs in
part 110 (Food) or 111 (dietary supplements).
• Preparation of a detailed assessment report, highlighting areas with highest level of risk and
vulnerability to company.
• Report of action plan for corrective action(s) of areas of non-compliance.
• Train staff on GMPs and General Best Practices, or help build a solid training program.
• Map your current processes to remove non-added value items, to create a tight, quality-rich
system.
• Experience with solid dose, softgel, liquids, and powder manufacturing and packaging
operations.
• Preparation of comprehensive SOPs
• CAPA (Corrective Action/Preventative Action), Root cause Analysis methods, Investigation
skills, Trend analysis and other Defect analysis tools
S.W.O.T. ANALYSIS
I will create and collaborate with you to develop a comprehensive analysis to help
you understand your STRENGTHS & WEAKNESSES, and identify areas of
OPPORTUNITY & THREATS you face.

4. • Set up a robust Consumer Complaint Handling System
• Adverse Event Handling and Serious Adverse Event Reporting System
• Build a Closed Loop Quality System
• Assist you in achieving certifications such as GMP: NPA, NSF, USP DSVP, UL, and others; Organic, Gluten Free, HACCP.
• Create compliant Master Manufacturing Record/Packaging Templates
• Set up a Material Review Board program as required by Regs for OOS (out of specification) materials
• Assist with creation of specifications for raw material, in-process and finished product. Set realistic parameters. Work with
QC, R&D and Manufacturing.
• Assist with FDA 483 comprehensive responses and implementation of corrective actions
• Assist with Regulatory communications
• Recall management and mitigation of business impact
• Set up analytical testing program including reduced testing rationale and stability testing program with “family” approach
ASSESS VULNERABLE AREAS
ACT ON INFORMATION
CLOSE GAPS
PROTECT YOUR COMPANY

5. • Set metrics to measure your Quality improvement program
• Help you build a Supplier Qualification Program
• Create GMP questionnaire for your vendors
• Analyze your vendor list and classify by criticality to business, type of material/vendor and
risk of material
• Supplier Score cards
• Create SCAR (Supplier Corrective Action Report)
• Perform audits of your suppliers for you so your quality associates can stay in house. Provide
detailed reports to ensure the quality and continuity of your supply chain
• Help set up a HACCP plan for your product line(s)
Other items you need help with….ask me!
Resume and References will be provided