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Agenda

Understanding FDA Guidelines and Preparing for Audits

September 27-28, 2018
  • San Diego, CA

Agenda

Want more agenda details? Download the brochure.

DAY ONE Thursday September 27, 2018

7:00

Registration and Continental Breakfast

8:00

Chairperson’s Welcome and Opening Remarks

Jason McGuire
Vice President, Global Quality
Fagron

8:15

FDA KEYNOTE Insanitary Conditions in Compounding Facilities and CGMP Requirements for Outsourcing Facilities

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

9:00

Anatomy of An FDA Audit —
A Tour of the Audit and An Explanation of What, When and Why

Rachel Pontikes
Partner
Reed Smith LLP

9:45

A Guide for Investigating, Remediating and Preventing Excursions —
Real-World Example of a 483 on Environmental Monitoring

Seth DePasquale
Co-Owner & Pharmacist in Charge
BET Pharm

10:30

Networking and Refreshment Break

11:00

EXPERT PANEL DISCUSSION An Examination on How to Navigate Compliance with Both the FDA and the Pharmacy State Board

MODERATOR:

Alexander Pytlarz
Owner, Director of Pharmacy
The Compounding Center

PANELISTS:

Rachel Pontikes
Partner
Reed Smith LLP

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

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

11:45

Analysis of An Inspection at a 503B Facility

Shaun Noorian
Founder and Chief Executive Officer
Empower Pharmacy

12:30

Networking Luncheon

1:30

Advocating for the Compounding Industry

Aaron Lopez
Senior Political Consultant
MEDISCA

2:15 - 5:00

CHOOSE BETWEEN TWO CONCURRENT TRACKS

Track 503A CHAIRMAN:
Alexander Pytlarz,
Owner/Director of Pharmacy
The Compounding Center
Track 503B CHAIRMAN:
Rick Meyer, Out of State Inspector
Texas State Pharmacy Board;
President, Lead Consultant
Superior Laboratory Services

2:15

Building A Successful Cash Compounding Business

Dieter Steinmetz
Owner
Coast Compounding Pharmacy

3:00

Networking Break

3:30

Identifying Insanitary Conditions in 503A Pharmacies

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

4:15

How to Survive a DEA Inspection Series — DEA and a 503A Compounding Pharmacy Inspection

Carlos Aquino
Compliance Consultant, Founder
Pharma Diversion LLC

5:00

Explanations of Requirements for Compliant Stability Studies

Nayan Patel, PharmD
President and Chief Operating Officer
Central Drugs

2:15

How to Survive a DEA Inspection Series — DEA and the inspection of a 503B Manufacturer

Carlos Aquino
Compliance Consultant, Founder
Pharma Diversion LLC

3:00

Networking Break

3:30

Effectively Creating Registration and Product Reporting of Human Drug Compounding Outsourcing Facilities

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

4:15

Implementation and Maintenance of a Key Compliance Element in 503B — SOPs and Document Control

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

5:00

Explanations of Requirements for Compliant Stability Studies

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

5:30

Close of Day One

Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWOFriday September 28, 2018

8:00

Continental Breakfast

8:30

Chairperson’s Review of Day One

Jason McGuire
Vice President, Global Quality
Fagron

8:45

Review FDA Guidance for Use of Bulk Powders

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

9:30

Understand and Conform To USP 800 Guidelines and How They Relate To Changes with USP 797 and 795

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

10:15

Networking and Refreshment Break

10:45

Piecing It All Together — A Right Sized Approach to Properly Applying FDA Regulations and Guidance Documents to Sterile Compounding Operations

Brian M. Spencer
Director, Quality Assurance
Eli Lilly and Company

11:30

Summarization of Process for Testing and Certification of Clean Rooms

Eric Feinstein
Manager, Quality Systems and Principal Scientist
Axia Pharmaceuticals

12:15

Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

DAY ONE Thursday September 27, 2018

7:00

Registration and Continental Breakfast

8:00

Chairperson’s Welcome and Opening Remarks

Jason McGuire
Vice President, Global Quality
Fagron

8:15

FDA KEYNOTE Insanitary Conditions in Compounding Facilities and CGMP Requirements for Outsourcing Facilities

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

9:00

Anatomy of An FDA Audit —
A Tour of the Audit and An Explanation of What, When and Why

Rachel Pontikes
Partner
Reed Smith LLP

9:45

A Guide for Investigating, Remediating and Preventing Excursions —
Real-World Example of a 483 on Environmental Monitoring

Seth DePasquale
Co-Owner & Pharmacist in Charge
BET Pharm

10:30

Networking and Refreshment Break

11:00

EXPERT PANEL DISCUSSION An Examination on How to Navigate Compliance with Both the FDA and the Pharmacy State Board

MODERATOR:

Alexander Pytlarz
Owner, Director of Pharmacy
The Compounding Center

PANELISTS:

Rachel Pontikes
Partner
Reed Smith LLP

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

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

11:45

Analysis of An Inspection at a 503B Facility

Shaun Noorian
Founder and Chief Executive Officer
Empower Pharmacy

12:30

Networking Luncheon

1:30

Advocating for the Compounding Industry

Aaron Lopez
Senior Political Consultant
MEDISCA

2:15 - 5:00

CHOOSE BETWEEN TWO CONCURRENT TRACKS

Track 503A CHAIRMAN:
Alexander Pytlarz,
Owner/Director of Pharmacy
The Compounding Center
Track 503B CHAIRMAN:
Rick Meyer, Out of State Inspector
Texas State Pharmacy Board;
President, Lead Consultant
Superior Laboratory Services

2:15

Building A Successful Cash Compounding Business

Dieter Steinmetz
Owner
Coast Compounding Pharmacy

3:00

Networking Break

3:30

Identifying Insanitary Conditions in 503A Pharmacies

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

4:15

How to Survive a DEA Inspection Series — DEA and a 503A Compounding Pharmacy Inspection

Carlos Aquino
Compliance Consultant, Founder
Pharma Diversion LLC

5:00

Explanations of Requirements for Compliant Stability Studies

Nayan Patel, PharmD
President and Chief Operating Officer
Central Drugs

2:15

How to Survive a DEA Inspection Series — DEA and the inspection of a 503B Manufacturer

Carlos Aquino
Compliance Consultant, Founder
Pharma Diversion LLC

3:00

Networking Break

3:30

Effectively Creating Registration and Product Reporting of Human Drug Compounding Outsourcing Facilities

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

4:15

Implementation and Maintenance of a Key Compliance Element in 503B — SOPs and Document Control

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

5:00

Explanations of Requirements for Compliant Stability Studies

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

5:30

Close of Day One

Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWOFriday September 28, 2018

8:00

Continental Breakfast

8:30

Chairperson’s Review of Day One

Jason McGuire
Vice President, Global Quality
Fagron

8:45

Review FDA Guidance for Use of Bulk Powders

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

9:30

Understand and Conform To USP 800 Guidelines and How They Relate To Changes with USP 797 and 795

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

10:15

Networking and Refreshment Break

10:45

Piecing It All Together — A Right Sized Approach to Properly Applying FDA Regulations and Guidance Documents to Sterile Compounding Operations

Brian M. Spencer
Director, Quality Assurance
Eli Lilly and Company

11:30

Summarization of Process for Testing and Certification of Clean Rooms

Eric Feinstein
Manager, Quality Systems and Principal Scientist
Axia Pharmaceuticals

12:15

Close of Conference