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DAY ONE — WEDNESDAY, JUNE 19, 2019

7:15

Registration and Continental Breakfast

8:00

Chairman’s Welcome and Opening Remarks

Nancy Costlow
Director of Operations
Atlas Pharmaceuticals

Deep Dive into the Regulations and
Enforcement Trends in Compounding Today

8:15

FDA SHOWCASE Examine FDA Priorities and Policies for Drug Compounding

Gabrielle Cosel
Policy Analyst, CDER Office of Compliance
Food and Drug Administration

Review CGMP Requirements and Ensure Compliance with Revised 503B Guidance

Ian Deveau, PhD
Division Director (Acting)
FDA/CDER/OC/OMQ/Division of Drug Quality 3

9:35

Examine the Scope of Current Enforcement Trends in Compounding

John W.M. Claud
Assistant Director
U.S. Department of Justice

10:15

Networking and Refreshment Break

10:45

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 & Medicine
PCCA Pharmacy Consulting

Enhance Compliance Programs with
Improved Operating Procedures

11:35

Build an Effective Quality Assurance/Quality Control Unit

Sara Mott
Quality Assurance Manager
Edge Pharmacy

12:15

Networking Luncheon

1:15

Considerations for Hazardous Drug Compounding in Sterile and
Non-Sterile Facilities

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

1:55

Validation and Implementation of SCANRDI® —
A Rapid Microbiology Method for Testing the Sterility of Filterable Drug Products

Anthony T Grilli
Laboratory Director
Atlas Analytical Inc.

2:40

Networking and Refreshment Break

3:10-5:30   CHOOSE BETWEEN TWO TRACKS

TRACK 503A

CHAIRMAN:

Donnie Calhoun
Chief Executive Officer
Calhoun Wellness Pharmacy

3:10

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

Donnie Calhoun
Chief Executive Officer
Calhoun Wellness Pharmacy

4:00

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.

4:40

PANEL Compare 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:

Nancy Costlow
Director of Operations
Atlas Pharmaceuticals

3:10

Evaluate the Importance of cGMP to the Safety of Compounded Drugs

Gary E. Ritchie
President
GER Compliance

4:00

Develop Personnel Training for
GMP Compliance

Nancy Costlow
Director of Operations
Atlas Pharmaceuticals

4:40

INTERACTIVE TABLE TALK Address Real World GMP Compliance Challenges

MODERATORS:

Grace Breen
Senior Vice President of Quality
SCA Pharma

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

Ross Caputo, PhD
President
Eagle Analytical Services

5:30

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

7:45

Continental Breakfast

8:30

Chairman’s Review of Day One

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

8:40

Explore Techniques for Environmental Monitoring

Seth DePasquale
Owner and Pharmacist in Charge
BET Pharm

9:20

Discuss Techniques for Cleaning Validation

Melissa Stefko
Vice President, Quality Assurance
Wells Pharmacy Network

10:00

Assessment of Extraneous Peaks in Compounded Products: A Chromatographic Mapping Approach

Lisa McChesney-Harris, Ph.D.
CEO, CSO & Founder
Prompt Praxis Laboratories LLC

10:40

Networking and Refreshment Break

11:10

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

Gary E. Ritchie
President
GER Compliance

Prepare for Facility Inspections and
Respond to 483s

11:50

Prepare for Your Upcoming Inspection

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

Robert W. Stannard
Partner
Bendin Sumrall & Ladner

Alexander Pytlarz
Vice President of Operations
Infuserve America

12:40

Networking Luncheon

1:40

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

Willis Triplett
Principal
Comply797

2:20

FINAL TAKEAWAYS AND CLOSING DISCUSSION Why 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

3:00

Close of Conference

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DAY ONE — WEDNESDAY, JUNE 19, 2019

7:15

Registration and Continental Breakfast

8:00

Chairman’s Welcome and Opening Remarks

Nancy Costlow
Director of Operations
Atlas Pharmaceuticals

Deep Dive into the Regulations and
Enforcement Trends in Compounding Today

8:15

FDA SHOWCASE Examine FDA Priorities and Policies for Drug Compounding

Gabrielle Cosel
Policy Analyst, CDER Office of Compliance
Food and Drug Administration

Review CGMP Requirements and Ensure Compliance with Revised 503B Guidance

Ian Deveau, PhD
Division Director (Acting)
FDA/CDER/OC/OMQ/Division of Drug Quality 3

9:35

Examine the Scope of Current Enforcement Trends in Compounding

John W.M. Claud
Assistant Director
U.S. Department of Justice

10:15

Networking and Refreshment Break

10:45

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 & Medicine
PCCA Pharmacy Consulting

Enhance Compliance Programs with
Improved Operating Procedures

11:35

Build an Effective Quality Assurance/Quality Control Unit

Sara Mott
Quality Assurance Manager
Edge Pharmacy

12:15

Networking Luncheon

1:15

Considerations for Hazardous Drug Compounding in Sterile and
Non-Sterile Facilities

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

1:55

Validation and Implementation of SCANRDI® —
A Rapid Microbiology Method for Testing the Sterility of Filterable Drug Products

Anthony T Grilli
Laboratory Director
Atlas Analytical Inc.

2:40

Networking and Refreshment Break

3:10-5:30   CHOOSE BETWEEN TWO TRACKS

TRACK 503A

CHAIRMAN:

Donnie Calhoun
Chief Executive Officer
Calhoun Wellness Pharmacy

3:10

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

Donnie Calhoun
Chief Executive Officer
Calhoun Wellness Pharmacy

4:00

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.

4:40

PANEL Compare 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:

Nancy Costlow
Director of Operations
Atlas Pharmaceuticals

3:10

Evaluate the Importance of cGMP to the Safety of Compounded Drugs

Gary E. Ritchie
President
GER Compliance

4:00

Develop Personnel Training for
GMP Compliance

Nancy Costlow
Director of Operations
Atlas Pharmaceuticals

4:40

INTERACTIVE TABLE TALK Address Real World GMP Compliance Challenges

MODERATORS:

Grace Breen
Senior Vice President of Quality
SCA Pharma

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

Ross Caputo, PhD
President
Eagle Analytical Services

5:30

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

7:45

Continental Breakfast

8:30

Chairman’s Review of Day One

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

8:40

Explore Techniques for Environmental Monitoring

Seth DePasquale
Owner and Pharmacist in Charge
BET Pharm

9:20

Discuss Techniques for Cleaning Validation

Melissa Stefko
Vice President, Quality Assurance
Wells Pharmacy Network

10:00

Assessment of Extraneous Peaks in Compounded Products: A Chromatographic Mapping Approach

Lisa McChesney-Harris, Ph.D.
CEO, CSO & Founder
Prompt Praxis Laboratories LLC

10:40

Networking and Refreshment Break

11:10

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

Gary E. Ritchie
President
GER Compliance

Prepare for Facility Inspections and
Respond to 483s

11:50

Prepare for Your Upcoming Inspection

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

Robert W. Stannard
Partner
Bendin Sumrall & Ladner

Alexander Pytlarz
Vice President of Operations
Infuserve America

12:40

Networking Luncheon

1:40

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

Willis Triplett
Principal
Comply797

2:20

FINAL TAKEAWAYS AND CLOSING DISCUSSION Why 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

3:00

Close of Conference