OCRA SDRAN Full Day Meeting: CAPA: Successful Strategies for a Comprehensive Program

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DURING REGISTRATION SELECT ONE OPTION, "IN PERSON" OR "WEBINAR"

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San Diego Regulatory Affairs Network (SDRAN) and Orange County Regulatory Affairs Discussion Group (OCRA)

Invite You to Join Us For A Full Day Meeting

Wednesday, October 11, 2017

CAPA: Successful Strategies for a Comprehensive Program Regulatory Updates and Best Practices

Program Managers:

Frank Pokrop, Director, Quality and Regulatory Affairs, BD

Kim Walker, RAC, FRAPS, VP of Regulatory, Quality, and Clinical Affairs, Hycor Biomedical

Speakers:

Larry Bartkus, Distinguished Engineer Quality Systems, Edwards Lifesciences

Thomas Gramlich, Quality Systems Manager, LoneStar Heart, Inc.

CDR Katherine Jacobitz, Supervisory Consumer Safety Officer, U.S. Food and Drug Administration, San Diego

James R. Lusk, RAC, Principal, Quality Systems International

Keith McLain, VP, Quality Assurance, CareFusion

Mark Perkins, Principal Consultant, Medical Device, QA/RA Consulting Group, Inc.

Shawn Veguilla, Client Manager, BSI GroupProgram

Event Agenda: Wednesday, October 11, 2017

8:00 – 8:30 am Registration, Networking, and Continental Breakfast

8:30 – 8:45 am Welcome Remarks

Frank Pokrop, Director, Quality and Regulatory Affairs, BD and

Kim Walker, RAC, FRAPS, VP of Regulatory, Quality, and Clinical Affairs, Hycor Biomedical

8:45 – 9:30 am FDA’s Perspective - Effective CAPAs and 483 Observations

CDR Katherine Jacobitz, Supervisory Consumer Safety Officer

U.S. Food and Drug Administration, San Diego

9:30 – 10:15 am EU’s Perspective – Effective CAPAs and Audit Observations

Shawn Veguilla, Client Manager, BSI Group

10:15 – 10:45 am Break and Networking

10:45 – 11:30 am Best Practices in Managing CAPAs and Reporting CAPA Data to Management

Mark Perkins, Principal Consultant, Medical Device, QA/RA Consulting Group

11:30 am – 12:15 pm CAPA Appropriate Statistical Techniques

Larry Bartkus, Distinguished Engineer Quality Systems, Edwards Lifesciences

12:15 – 1:30 pm Lunch and Networking

1:30 – 2:15 pm Robust Root Cause Analysis

Thomas Gramlich, Quality Systems Manager, LoneStar Heart, Inc.

2:15 – 3:00 pm Integrating Risk Management into CAPAs

Keith McLain, VP, Quality Assurance, CareFusion

3:00 – 3:30 pm Break and Networking

3:30 – 4:15 pm Compare and Contrast Drug and Device CAPA Best Practices

James R. Lusk, RAC, Principal, Quality Systems International

4:15 – 5:00 pm Panel Discussion, Speaker Q&A, and Closing Remarks

LOCATION:

Holiday Inn Carlsbad

2725 Palomar Airport Road

Carlsbad, CA 92009

Synopsis:

Please join us on October 11 for a joint meeting with SDRAN and OCRA. Corrective And Preventive Action (CAPA) has always been a hot topic for quality and regulatory affairs professionals. OCRA has not had a full day CAPA meeting for over three years. Here's your chance to learn from the experts to hear how their company maintains a successful CAPA program.

We will hear from the FDA, who will discuss effective CAPAs and 483 observations. Industry speakers will share their company best practices and industry trends in the US and EU. Statistics, root cause analysis and integration with risk management will be discussed. The last presentation will compare and contrast drug and device CAPA practices. At the end of the day, all speakers will be on a panel for the audience to direct questions.

Please make your reservation early. The online registration due date is October 10, 2017. Only credit cards are accepted for registration.

Registration for In-Person Meeting Format: $175 SDRAN Member, $230 Non-Member

Registration for Webinar Meeting Format: $125 SDRAN Member, $180 Non-Member

DIRECTIONS:

From San Diego:

Take I-5 North.

Take Exit 47 for Palomar Airport Rd.

Use the Right 2 lanes to turn Right onto Palomar Airport Rd.

Go approximately four miles.

Hotel will be on the corner of Palomar Airport Rd and Innovation Way.

From Orange County or Los Angeles:

Take I-5 South.

Take Exit 47 for Palomar Airport Rd.

Use the Left 2 lanes to turn Left onto Palomar Airport Rd.

Go approximately four miles.

Hotel will be on the corner of Palomar Airport Rd and Innovation Way.

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