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Agenda

Navigate the Changing Regulatory Landscape and Enhance Quality Programs

September 17-18, 2019
  • San Diego, CA

Agenda

Want more agenda details? Download the brochure.

DAY ONE Tuesday, September 17, 2019

7:00

Registration and Continental Breakfast

8:00

Chairperson’s Welcome and Opening Remarks

Robert Nickell
CEO and Founder
Nubratori RX

Stay Up-to-Date on Recent Policy Changes for Compounding Pharmacies

8:15

FDA Keynote Outline FDA Priorities and Policies for Oversight of Drug Compounding

Sara Rothman, MPH
Senior Policy Advisor,
Office of Unapproved Drugs & Labeling Compliance
FDA

9:00

PANEL Review FDA Guidance on Use of Bulk Substances and Essential Copies

MODERATOR:

Lee Rosebush
Partner
BakerHostetler

PANELISTS:

David Short
Vice President of Quality
QuVa Pharma

John H. McEniry, IV
Senior Vice President, Legal and Governmental Affairs
Fagron North America

Rachael G. Pontikes
Partner
Reed Smith LLC

10:00

Networking and Refreshment Break

10:30

Examine the Scope of Current Enforcement Trends in Compounding —
483s, Warning Letters, Recalls and Other Enforcement Actions

John H. McEniry, IV
Senior Vice President, Legal and Governmental Affairs
Fagron North America

Lee Rosebush
Partner
BakerHostetler

Assess Updated Quality Standards and Adopt Best Practices to Improve Pharmacy Operations

11:15

Risk Mitigation and Maintenance of Sanitary Conditions in Compounding Facilities

Ross Caputo, PhD
President
Eagle 

12:00

Networking Luncheon

1:00

Sterility Assurance Guidelines — USP versus cGMP

Lisa McChesney-Harris, PhD
CEO, CSO & Founder
Prompt Praxis Laboratories LLC

1:45

Build an Effective Quality Assurance/ Quality Control Program

Seth DePasquale, RPh
Co-Owner & Pharmacist in Charge
BET Pharm

2:30

How to Implement a Rapid Method for Sterility Testing in a 503B Outsourcing Facility

Eric Feinstein
Quality Systems Manager and Principal Scientist
Axia Pharmaceutical

3:15

Networking and Refreshment Break

3:45–5:30

CHOOSE BETWEEN THREE CONCURRENT TRACKS (A-C)

A 503A TRACK

3:45

Track Chairperson’s Opening Remarks

Christine Stephanos, RPh
Chief Scientific Officer
Valor Compounding Pharmacy

4:00

Understand and Incorporate USP Standards into Compounding Practices

L. Rad Dillon, ASQ CMQ/OE, ASQ CQA, ACHC/PCAB CAC, ASQ SSGB, ACHC
Surveyor and Pharmacy Consultant
LR Dillon Pharmacy Consulting

4:45

Strategies to Design and Maintain a Compliant Compounding Pharmacy

Christine Stephanos, RPh
Chief Scientific Officer
Valor Compounding Pharmacy

B 503B TRACK

3:45

Track Chairperson’s Opening Remarks

Robert Nickell
CEO and Founder
Nubratori RX

4:00

Outline Practical Applications of Revised GMP Guidelines
in Outsourcing Facilities

Adrienne Leyland
Quality Assurance Officer
Atlas Pharmaceuticals

4:45

Develop Personnel Training for GMP Compliance

Deborah McHugh
Director of Quality Assurance
Fresenius Kabi Compounding, LLC

C HOSPITAL/HEALTH SYSTEM TRACK

3:45

Track Chair’s Opening Remarks

Robert Eastin, PharmD
PharmD, Director of Pharmacy
Scripps Health

4:00

Mitigate the Impact of Drug Shortages on In-house vs. Outsourced Compounding

Michael Freudiger, PharmD, BCPS, BCGP
Independent Contractor Consultant
ASHP Consulting

David Short
Vice President of Quality
QuVa Pharma

4:45

Best Practices for Standardizing Compliant Compounding Across Health Systems

MODERATOR:

Robert Eastin, PharmD
PharmD, Director of Pharmacy
Scripps Health

PANELISTS:

Erika Anderson, CPhT, CSPT
Division Program Manager, Pharmacy Compounding
CHI Franciscan

Daryl Schiller, PharmD, FASHP, BCPS-AQ ID
Pharmacy Director
Montefiore Nyack

5:30

Close of Day One

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

DAY TWO Wednesday, September 18, 2019

7:30

Networking and Continental Breakfast

8:00–9:15

CHOOSE BETWEEN THREE CONCURRENT TRACKS (A-C)

A 503A TRACK

8:00

Track Chairperson’s Review of Day One

Christine Stephanos, RPh
Chief Scientific Officer
Valor Compounding Pharmacy

8:10

Consider a Future in 503B — The Transition from
503A to 503B and Practices to Adopt to Improve Your Facility

Doug Cammann, RPh
Vice President of Operations
AnazaoHealth Corporation Las Vegas

8:55

Inspection Preparation and Response —
What to Expect in an Inspection of a 503A Pharmacy

Karla Palmer
Director
Hyman, Phelps & McNamara

Gina Gilsoul, PharmD, RPh
Quality Control Officer
Union Avenue Compounding Pharmacy

B 503B TRACK

8:00

Track Chairperson’s Review of Day One

Robert Nickell
CEO and Founder
Nubratori RX

8:10

cGMP Change Control – Basics and Best Practices

Jules Dsouza
Senior Director of Quality
Qualgen

8:55

PANELInspection Preparation and Response —
What to Expect in an Inspection of a 503B Pharmacy

Melissa Stefko
Vice President of Quality
Wells Pharmacy Network

Jules Dsouza
Senior Director of Quality
Qualgen

Eric Feinstein
Quality Systems Manager and Principal Scientist
Axia Pharmaceutical

C HOSPITAL/HEALTH SYSTEM TRACK

8:00

Track Chairperson’s Review of Day One

Robert Eastin, PharmD
PharmD, Director of Pharmacy
Scripps Health

8:10

How To Become a Best-In-Class Compounding Pharmacy

Kevin Hansen, PharmD, MS, BCSP
Assistant Director of Pharmacy
Moses H. Cone Memorial Hospital

8:55

Inspection Preparation and Response — What to Expect
in a Joint Commission Inspection of a Hospital/Health-System Pharmacy

Daryl Schiller, PharmD, FASHP, BCPS-AQ ID
Pharmacy Director
Montefiore Nyack

Russell Odegard
Chief Executive Officer
Dynalabs

9:40

Five-Minute Transition Break

9:45

CHOOSE FROM TWO COMPREHENSIVE BREAKOUTS (I-II)

I 503A & Hospital/Health System Breakout

9:45

Breakout Chair’s Review of Day One

Robert Eastin, PharmD
PharmD, Director of Pharmacy
Scripps Health

10:00

PANEL | Compare Key Players — FDA, State Board and Industry Perspectives on Compliance

MODERATOR:

Rachael G. Pontikes
Partner
Reed Smith LLC

PANELISTS:

Devin Wallace, CPhT, CSPT, RPhT, PRS,
President & Consultant
Wallace Ventures

L. Rad Dillon, ASQ CMQ/OE, ASQ CQA, ACHC/PCAB CAC, ASQ SSGB, ACHC
Surveyor and Pharmacy Consultant
LR Dillon Pharmacy Consulting

Sara Rothman, MPH
Senior Policy Advisor, Office of
Unapproved Drugs & Labeling Compliance
FDA

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

 
II 503B Breakout

9:45

Breakout Chair’s Review of Day One

Robert Nickell
CEO and Founder
Nubratori RX

10:00

ROUNDTABLES | Address Real World GMP Compliance Challenges

DISCUSSION LEADERS:

Adrienne Leyland
Quality Assurance Officer
Atlas Pharmaceuticals

David Smith
Owner
Prestige Pharmacy Outsourcing Advisors

Lee Rosebush
Partner
BakerHostetler

10:45

Networking and Refreshment Break

11:10

IACP Introduction and Welcome

Erin Michael, MBA, MS, CPhT
IACP Board Member and IACPF President
IACP

11:15

ROUNDTABLE DISCUSSIONS USP <800> and <797> Readiness Roundtables

MODERATORS:

Seth DePasquale, RPh
Co-Owner & Pharmacist in Charge
BET Pharm

Erika Anderson, CPhT, CSPT
Division Program Manager, Pharmacy Compounding
CHI Franciscan

Nadia Ibrahim, RPh
General Manager
Park Compounding

Devin Wallace, CPhT, CSPT, RPhT, PRS
President & Consultant
Wallace Ventures

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

12:00

Implement a Compliant Environmental Monitoring System to Enhance Quality

Cheryl Zaman Zadeh/Famili
Director, Business Development & Sales
Novatek International

12:45

Networking Luncheon

1:45

Review Best Practices for Stability Testing and Beyond Use Dating

Rick Rhoads, PharmD
Director of Compounding
University Compounding Pharmacy

Thomas C. Kupiec, PhD
CEO
ARL Bio Pharma

2:30

CLOSED-DOOR SESSION Compounders-Only Discussion

This interactive discussion provides an opportunity for compounding pharmacists to convene in a private session and discuss key takeaways and practices gained to ensure continued compliance. Participants are encouraged to bring remaining questions to this session to benefit from peer-to-peer perspectives from compounders of various sizes and specialties

MODERATOR:

Peter Koshland
Owner
Koshland Compounding Pharmacy

3:00

Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

DAY ONE Tuesday, September 17, 2019

7:00

Registration and Continental Breakfast

8:00

Chairperson’s Welcome and Opening Remarks

Robert Nickell
CEO and Founder
Nubratori RX

Stay Up-to-Date on Recent Policy Changes for Compounding Pharmacies

8:15

FDA Keynote Outline FDA Priorities and Policies for Oversight of Drug Compounding

Sara Rothman, MPH
Senior Policy Advisor,
Office of Unapproved Drugs & Labeling Compliance
FDA

9:00

PANEL Review FDA Guidance on Use of Bulk Substances and Essential Copies

MODERATOR:

Lee Rosebush
Partner
BakerHostetler

PANELISTS:

David Short
Vice President of Quality
QuVa Pharma

John H. McEniry, IV
Senior Vice President, Legal and Governmental Affairs
Fagron North America

Rachael G. Pontikes
Partner
Reed Smith LLC

10:00

Networking and Refreshment Break

10:30

Examine the Scope of Current Enforcement Trends in Compounding —
483s, Warning Letters, Recalls and Other Enforcement Actions

John H. McEniry, IV
Senior Vice President, Legal and Governmental Affairs
Fagron North America

Lee Rosebush
Partner
BakerHostetler

Assess Updated Quality Standards and Adopt Best Practices to Improve Pharmacy Operations

11:15

Risk Mitigation and Maintenance of Sanitary Conditions in Compounding Facilities

Ross Caputo, PhD
President
Eagle 

12:00

Networking Luncheon

1:00

Sterility Assurance Guidelines — USP versus cGMP

Lisa McChesney-Harris, PhD
CEO, CSO & Founder
Prompt Praxis Laboratories LLC

1:45

Build an Effective Quality Assurance/ Quality Control Program

Seth DePasquale, RPh
Co-Owner & Pharmacist in Charge
BET Pharm

2:30

How to Implement a Rapid Method for Sterility Testing in a 503B Outsourcing Facility

Eric Feinstein
Quality Systems Manager and Principal Scientist
Axia Pharmaceutical

3:15

Networking and Refreshment Break

3:45–5:30

CHOOSE BETWEEN THREE CONCURRENT TRACKS (A-C)

A 503A TRACK

3:45

Track Chairperson’s Opening Remarks

Christine Stephanos, RPh
Chief Scientific Officer
Valor Compounding Pharmacy

4:00

Understand and Incorporate USP Standards into Compounding Practices

L. Rad Dillon, ASQ CMQ/OE, ASQ CQA, ACHC/PCAB CAC, ASQ SSGB, ACHC
Surveyor and Pharmacy Consultant
LR Dillon Pharmacy Consulting

4:45

Strategies to Design and Maintain a Compliant Compounding Pharmacy

Christine Stephanos, RPh
Chief Scientific Officer
Valor Compounding Pharmacy

B 503B TRACK

3:45

Track Chairperson’s Opening Remarks

Robert Nickell
CEO and Founder
Nubratori RX

4:00

Outline Practical Applications of Revised GMP Guidelines
in Outsourcing Facilities

Adrienne Leyland
Quality Assurance Officer
Atlas Pharmaceuticals

4:45

Develop Personnel Training for GMP Compliance

Deborah McHugh
Director of Quality Assurance
Fresenius Kabi Compounding, LLC

C HOSPITAL/HEALTH SYSTEM TRACK

3:45

Track Chair’s Opening Remarks

Robert Eastin, PharmD
PharmD, Director of Pharmacy
Scripps Health

4:00

Mitigate the Impact of Drug Shortages on In-house vs. Outsourced Compounding

Michael Freudiger, PharmD, BCPS, BCGP
Independent Contractor Consultant
ASHP Consulting

David Short
Vice President of Quality
QuVa Pharma

4:45

Best Practices for Standardizing Compliant Compounding Across Health Systems

MODERATOR:

Robert Eastin, PharmD
PharmD, Director of Pharmacy
Scripps Health

PANELISTS:

Erika Anderson, CPhT, CSPT
Division Program Manager, Pharmacy Compounding
CHI Franciscan

Daryl Schiller, PharmD, FASHP, BCPS-AQ ID
Pharmacy Director
Montefiore Nyack

5:30

Close of Day One

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

DAY TWO Wednesday, September 18, 2019

7:30

Networking and Continental Breakfast

8:00–9:15

CHOOSE BETWEEN THREE CONCURRENT TRACKS (A-C)

A 503A TRACK

8:00

Track Chairperson’s Review of Day One

Christine Stephanos, RPh
Chief Scientific Officer
Valor Compounding Pharmacy

8:10

Consider a Future in 503B — The Transition from
503A to 503B and Practices to Adopt to Improve Your Facility

Doug Cammann, RPh
Vice President of Operations
AnazaoHealth Corporation Las Vegas

8:55

Inspection Preparation and Response —
What to Expect in an Inspection of a 503A Pharmacy

Karla Palmer
Director
Hyman, Phelps & McNamara

Gina Gilsoul, PharmD, RPh
Quality Control Officer
Union Avenue Compounding Pharmacy

B 503B TRACK

8:00

Track Chairperson’s Review of Day One

Robert Nickell
CEO and Founder
Nubratori RX

8:10

cGMP Change Control – Basics and Best Practices

Jules Dsouza
Senior Director of Quality
Qualgen

8:55

PANELInspection Preparation and Response —
What to Expect in an Inspection of a 503B Pharmacy

Melissa Stefko
Vice President of Quality
Wells Pharmacy Network

Jules Dsouza
Senior Director of Quality
Qualgen

Eric Feinstein
Quality Systems Manager and Principal Scientist
Axia Pharmaceutical

C HOSPITAL/HEALTH SYSTEM TRACK

8:00

Track Chairperson’s Review of Day One

Robert Eastin, PharmD
PharmD, Director of Pharmacy
Scripps Health

8:10

How To Become a Best-In-Class Compounding Pharmacy

Kevin Hansen, PharmD, MS, BCSP
Assistant Director of Pharmacy
Moses H. Cone Memorial Hospital

8:55

Inspection Preparation and Response — What to Expect
in a Joint Commission Inspection of a Hospital/Health-System Pharmacy

Daryl Schiller, PharmD, FASHP, BCPS-AQ ID
Pharmacy Director
Montefiore Nyack

Russell Odegard
Chief Executive Officer
Dynalabs

9:40

Five-Minute Transition Break

9:45

CHOOSE FROM TWO COMPREHENSIVE BREAKOUTS (I-II)

I 503A & Hospital/Health System Breakout

9:45

Breakout Chair’s Review of Day One

Robert Eastin, PharmD
PharmD, Director of Pharmacy
Scripps Health

10:00

PANEL | Compare Key Players — FDA, State Board and Industry Perspectives on Compliance

MODERATOR:

Rachael G. Pontikes
Partner
Reed Smith LLC

PANELISTS:

Devin Wallace, CPhT, CSPT, RPhT, PRS,
President & Consultant
Wallace Ventures

L. Rad Dillon, ASQ CMQ/OE, ASQ CQA, ACHC/PCAB CAC, ASQ SSGB, ACHC
Surveyor and Pharmacy Consultant
LR Dillon Pharmacy Consulting

Sara Rothman, MPH
Senior Policy Advisor, Office of
Unapproved Drugs & Labeling Compliance
FDA

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

 
II 503B Breakout

9:45

Breakout Chair’s Review of Day One

Robert Nickell
CEO and Founder
Nubratori RX

10:00

ROUNDTABLES | Address Real World GMP Compliance Challenges

DISCUSSION LEADERS:

Adrienne Leyland
Quality Assurance Officer
Atlas Pharmaceuticals

David Smith
Owner
Prestige Pharmacy Outsourcing Advisors

Lee Rosebush
Partner
BakerHostetler

10:45

Networking and Refreshment Break

11:10

IACP Introduction and Welcome

Erin Michael, MBA, MS, CPhT
IACP Board Member and IACPF President
IACP

11:15

ROUNDTABLE DISCUSSIONS USP <800> and <797> Readiness Roundtables

MODERATORS:

Seth DePasquale, RPh
Co-Owner & Pharmacist in Charge
BET Pharm

Erika Anderson, CPhT, CSPT
Division Program Manager, Pharmacy Compounding
CHI Franciscan

Nadia Ibrahim, RPh
General Manager
Park Compounding

Devin Wallace, CPhT, CSPT, RPhT, PRS
President & Consultant
Wallace Ventures

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

12:00

Implement a Compliant Environmental Monitoring System to Enhance Quality

Cheryl Zaman Zadeh/Famili
Director, Business Development & Sales
Novatek International

12:45

Networking Luncheon

1:45

Review Best Practices for Stability Testing and Beyond Use Dating

Rick Rhoads, PharmD
Director of Compounding
University Compounding Pharmacy

Thomas C. Kupiec, PhD
CEO
ARL Bio Pharma

2:30

CLOSED-DOOR SESSION Compounders-Only Discussion

This interactive discussion provides an opportunity for compounding pharmacists to convene in a private session and discuss key takeaways and practices gained to ensure continued compliance. Participants are encouraged to bring remaining questions to this session to benefit from peer-to-peer perspectives from compounders of various sizes and specialties

MODERATOR:

Peter Koshland
Owner
Koshland Compounding Pharmacy

3:00

Close of Conference