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Understanding FDA Guidelines and Preparing for Audits

September 27-28, 2018
  • San Diego, CA

Carlos Aquino
Compliance Consultant, Founder
Pharma Diversion LLC

Eric Bauer, RPh
Senior Consultant, CAPS
Consulting Central Admixture Pharmacy Services

Seth DePasquale
Co-Owner & Pharmacist in Charge
BET Pharm

Ian Deveau, PhD
Branch Chief, Office of Manufacturing Quality, Office of Compliance
CDER/FDA

Phillip De Noble, PharmD
Senior Manager, Regulatory Affairs
Baxter International Inc.

Eric Feinstein
Manager, Quality Systems and Principal Scientist
Axia Pharmaceuticals

Jonathan Fujimoto, PharmD, MBA
Pharmacist in Charge, Director of Pharmacy
Central Drugs

Paul M. Loebach
Director, Drug Registration and Listing Staff
FDA

Aaron Lopez
Senior Political Consultant
MEDISCA

Jason McGuire
Vice President, Global Quality
Fagron

Rick Meyer
Out of State Inspector, Texas State Pharmacy Board;
President, Lead Consultant, Superior Laboratory Services

Shaun Noorian
Founder and Chief Executive Officer
Empower Pharmacy

Karla Palmer
Partner
Hyman, Phelps & McNamara, P.C.

Nayan Patel, PharmD
President and Chief Operating Officer
Central Drugs

Rachel Pontikes
Partner
Reed Smith LLP

Alexander Pytlarz
Owner, Director of Pharmacy
The Compounding Center

Brian Spencer
Director, Quality Assurance
Eli Lilly and Company

Dieter Steinmetz
Partner
Coast Compounding Pharmacy

Carlos Aquino
Compliance Consultant, Founder
Pharma Diversion LLC

Eric Bauer, RPh
Senior Consultant, CAPS
Consulting Central Admixture Pharmacy Services

Seth DePasquale
Co-Owner & Pharmacist in Charge
BET Pharm

Ian Deveau, PhD
Branch Chief, Office of Manufacturing Quality, Office of Compliance
CDER/FDA

Phillip De Noble, PharmD
Senior Manager, Regulatory Affairs
Baxter International Inc.

Eric Feinstein
Manager, Quality Systems and Principal Scientist
Axia Pharmaceuticals

Jonathan Fujimoto, PharmD, MBA
Pharmacist in Charge, Director of Pharmacy
Central Drugs

Paul M. Loebach
Director, Drug Registration and Listing Staff
FDA

Aaron Lopez
Senior Political Consultant
MEDISCA

Jason McGuire
Vice President, Global Quality
Fagron

Rick Meyer
Out of State Inspector, Texas State Pharmacy Board;
President, Lead Consultant, Superior Laboratory Services

Shaun Noorian
Founder and Chief Executive Officer
Empower Pharmacy

Karla Palmer
Partner
Hyman, Phelps & McNamara, P.C.

Nayan Patel, PharmD
President and Chief Operating Officer
Central Drugs

Rachel Pontikes
Partner
Reed Smith LLP

Alexander Pytlarz
Owner, Director of Pharmacy
The Compounding Center

Brian Spencer
Director, Quality Assurance
Eli Lilly and Company

Dieter Steinmetz
Partner
Coast Compounding Pharmacy