Skip navigation
Agenda

Interpret Changing Guidelines • Strengthen Quality Programs • Prepare for Inspections

June 19-20, 2019
  • Silver Spring, MD

Agenda

Want more agenda details? Download the brochure.

DAY ONE — WEDNESDAY, JUNE 19, 2019

7:15

Registration and Continental Breakfast

8:15

Chairman’s Welcome and Opening Remarks

Ed Zatta, RPh
Chief Executive Officer
RXQ Compounding, LLC

Deep Dive into the Regulations and
Enforcement Trends in Compounding Today

8:15

FDA ADDRESSExamine FDA Priorities and Policies for Drug Compounding

Ian Deveau, Ph.D.
Branch Chief, Office of Manufacturing Quality, Office of Compliance
CDER/FDA (invited)

9:00

Examine the Scope of Current Enforcement Trends in Compounding

John W.M. Claud
Trial Attorney
U.S. Department of Justice

9:45

Networking and Refreshment Break

10:15/p>

Review FDA Guidance on Use of Bulk Substances and Essential Copies

MODERATOR:

Karla Palmer
Director
Hyman, Phelps, & McNamara

PANELISTS:

Pat Stephens
Former Owner
Medi-Fare Drug

Mike Koch
Senior Vice President, Professional Services
Central Admixture Pharmacy Services

Matt Martin
Clinical Compounding Pharmacist and Consultant of Pharmacy and Medicine
PCCA Pharmacy Consulting

Enhance Compliance Programs with Improved Operating Procedures

11:15

Build an Effective Quality Assurance/Quality Control Unit

Sara Mott
Quality Assurance Manager
Edge Pharmacy

12:00

Networking Luncheon

1:00

Considerations for Hazardous
Drug Compounding in Sterile and NonSterile Facilities

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

1:45

Explore Techniques for Environmental Monitoring

Seth DePasquale
Owner and Pharmacist in Charge
BET Pharm

2:45

Networking and Refreshment Break

3:00-5:15 CHOOSE BETWEEN TWO TRACKS

TRACK 503A

CHAIRMAN:

Donnie Calhoun
Chief Executive Officer
Calhoun Wellness Pharmacy

3:00

Mitigating Costs for Designing, Building and Maintaining a Compliant 503A Facility

Donnie Calhoun
Chief Executive Officer
Calhoun Wellness Pharmacy

3:45

Exploring a Future in 503B — The Transition from 503A to 503B and cGMP Standards to Implement to Improve Your Facility

Louis Diorio
Principal
LDT Health Solutions, Inc.

4:30

PANELCompare Key Players — FDA and Pharmacy State Board Perspectives on Compliance

MODERATOR

Warren Finlinson
Sterile Compounding Director
Wickliffe Veterinary Pharmacy

PANELISTS

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

Sheri Zapadka
Compliance Specialist
State of Ohio Board of Pharmacy

 
TRACK 503B

CHAIRMAN:

Ed Zatta
President
RXQ Compounding

3:00

Evaluate the Importance of cGMP to the Safety of Compounded Drugs

Gary E. Ritchie
President
GER Compliance

3:45

Develop Personnel Training for GMP Compliance

Nancy Costlow
Director of Operations
Atlas Pharmaceuticals

4:30

INTERACTIVE TABLE TALKAddress Real World GMP Compliance Challenges

MODERATORS:

Melissa Bainbridge
Science Director
Edge Pharmacy Services

Grace Breen
Senior Vice President of Quality
SCA Pharma

Erik Tosh
Chairman and 2018 President
IACP;
Vice President of Professional Services
Letco Medical

5:15

Close of Day One

Join Us for a Networking Wine and Cheese Reception
at the Close of Day One

DAY TWO — THURSDAY, JUNE 20, 2019

8:30

Continental Breakfast

9:00

Chairman’s Review of Day One

Jason McGuire
Vice President, Global Quality
Fagron

9:15

Discuss Techniques for Cleaning Validation

Melissa Stefko
Vice President of Quality Assurance
Wells Pharmacy Network

10:00

Stability Testing and Beyond-Use-Dates — Ensuring the Quality of Sterile and Non-Sterile Compounded Preparations

Gary E. Ritchie
President
GER Compliance

10:45

Networking and Refreshment Break

Prepare for Facility Inspections and Respond to 483s

11:00

EXTENDED SESSION Prepare for Your Upcoming Inspection

Robert W. Stannard, Esq.
Partner
Bendin Sumrall & Ladner

Stephen T. Snow, Esq.
Partner
Bendin Sumrall & Ladner

12:00

Networking Luncheon

1:15

A Review of 483s and Warning Letters — Effective Response Strategies

Willis Triplett
Principal
Comply797

2:00

FINAL TAKEAWAYS AND CLOSING DISCUSSIONWhy We Compound — Advocating for Patients and the Industry

Lisa D. Ashworth
Compounding Specialist and Clinical Pharmacist
Children’s Healthcare System of Texas

Jake Olson
President/Chief Executive Officer
Skywalk Pharmacy

2:45

Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

DAY ONE — WEDNESDAY, JUNE 19, 2019

7:15

Registration and Continental Breakfast

8:15

Chairman’s Welcome and Opening Remarks

Ed Zatta, RPh
Chief Executive Officer
RXQ Compounding, LLC

Deep Dive into the Regulations and
Enforcement Trends in Compounding Today

8:15

FDA ADDRESSExamine FDA Priorities and Policies for Drug Compounding

Ian Deveau, Ph.D.
Branch Chief, Office of Manufacturing Quality, Office of Compliance
CDER/FDA (invited)

9:00

Examine the Scope of Current Enforcement Trends in Compounding

John W.M. Claud
Trial Attorney
U.S. Department of Justice

9:45

Networking and Refreshment Break

10:15/p>

Review FDA Guidance on Use of Bulk Substances and Essential Copies

MODERATOR:

Karla Palmer
Director
Hyman, Phelps, & McNamara

PANELISTS:

Pat Stephens
Former Owner
Medi-Fare Drug

Mike Koch
Senior Vice President, Professional Services
Central Admixture Pharmacy Services

Matt Martin
Clinical Compounding Pharmacist and Consultant of Pharmacy and Medicine
PCCA Pharmacy Consulting

Enhance Compliance Programs with Improved Operating Procedures

11:15

Build an Effective Quality Assurance/Quality Control Unit

Sara Mott
Quality Assurance Manager
Edge Pharmacy

12:00

Networking Luncheon

1:00

Considerations for Hazardous
Drug Compounding in Sterile and NonSterile Facilities

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

1:45

Explore Techniques for Environmental Monitoring

Seth DePasquale
Owner and Pharmacist in Charge
BET Pharm

2:45

Networking and Refreshment Break

3:00-5:15 CHOOSE BETWEEN TWO TRACKS

TRACK 503A

CHAIRMAN:

Donnie Calhoun
Chief Executive Officer
Calhoun Wellness Pharmacy

3:00

Mitigating Costs for Designing, Building and Maintaining a Compliant 503A Facility

Donnie Calhoun
Chief Executive Officer
Calhoun Wellness Pharmacy

3:45

Exploring a Future in 503B — The Transition from 503A to 503B and cGMP Standards to Implement to Improve Your Facility

Louis Diorio
Principal
LDT Health Solutions, Inc.

4:30

PANELCompare Key Players — FDA and Pharmacy State Board Perspectives on Compliance

MODERATOR

Warren Finlinson
Sterile Compounding Director
Wickliffe Veterinary Pharmacy

PANELISTS

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

Sheri Zapadka
Compliance Specialist
State of Ohio Board of Pharmacy

 
TRACK 503B

CHAIRMAN:

Ed Zatta
President
RXQ Compounding

3:00

Evaluate the Importance of cGMP to the Safety of Compounded Drugs

Gary E. Ritchie
President
GER Compliance

3:45

Develop Personnel Training for GMP Compliance

Nancy Costlow
Director of Operations
Atlas Pharmaceuticals

4:30

INTERACTIVE TABLE TALKAddress Real World GMP Compliance Challenges

MODERATORS:

Melissa Bainbridge
Science Director
Edge Pharmacy Services

Grace Breen
Senior Vice President of Quality
SCA Pharma

Erik Tosh
Chairman and 2018 President
IACP;
Vice President of Professional Services
Letco Medical

5:15

Close of Day One

Join Us for a Networking Wine and Cheese Reception
at the Close of Day One

DAY TWO — THURSDAY, JUNE 20, 2019

8:30

Continental Breakfast

9:00

Chairman’s Review of Day One

Jason McGuire
Vice President, Global Quality
Fagron

9:15

Discuss Techniques for Cleaning Validation

Melissa Stefko
Vice President of Quality Assurance
Wells Pharmacy Network

10:00

Stability Testing and Beyond-Use-Dates — Ensuring the Quality of Sterile and Non-Sterile Compounded Preparations

Gary E. Ritchie
President
GER Compliance

10:45

Networking and Refreshment Break

Prepare for Facility Inspections and Respond to 483s

11:00

EXTENDED SESSION Prepare for Your Upcoming Inspection

Robert W. Stannard, Esq.
Partner
Bendin Sumrall & Ladner

Stephen T. Snow, Esq.
Partner
Bendin Sumrall & Ladner

12:00

Networking Luncheon

1:15

A Review of 483s and Warning Letters — Effective Response Strategies

Willis Triplett
Principal
Comply797

2:00

FINAL TAKEAWAYS AND CLOSING DISCUSSIONWhy We Compound — Advocating for Patients and the Industry

Lisa D. Ashworth
Compounding Specialist and Clinical Pharmacist
Children’s Healthcare System of Texas

Jake Olson
President/Chief Executive Officer
Skywalk Pharmacy

2:45

Close of Conference