2013 pda pharmaceutical quality metrics conference brochure

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www.pda.org/metrics2013Exhibition: December 9-10

This preliminary agenda is current as of August 21, 2013.

The Parenteral Drug Association presents...

2013 PDA Pharmaceutical Quality Metrics

ConferenceDecember 9-10, 2013 Bethesda North Marriott Hotel

& Conference Center Bethesda, Maryland

Register before October 29 and save.

Meeting led by PDA in

cooperation with the U.S. FDA

www.pda.org/metrics20132

Program Planning Committee

A Message from the Program Co-Chairs

Co-chair:Steven MendivilAmgen, Inc.

Co-chair:Russell Wesdyk FDA

Joyce Bloomfield Merck Sharp & Dohme Corporation

Ian ElvinsElvins and Associates

Richard FriedmanFDA

Marty NealeyHospira

Faiad Rahaman FDA

Anil SawantJohnson and Johnson Susan SchnieppAllergy Laboratories, Inc.

Alex ViehmanFDA Anders Vinther, PhDGenentech, Inc.

Glenn WrightEli Lilly & Company

Jason BrownPDA

Wanda NealPDA

Dear Colleagues,

Congress passed legislation in 2012 known as FDASIA that directs FDA to conduct

do risk based inspections and allows them to collect records otherwise available on

inspection “in advance or in lieu of inspections”.

This is a PDA / FDA led conference focusing on Quality Metrics as a possible input

into FDA Inspectional Risk Model. This would allow FDA to better allocate their

inspectional resources and focus on higher impact areas. For a number of years

pharmaceutical companies have been utilizing metrics and scorecards to help

drive Quality and business improvements with varying degrees of success. This

conference will be an opportunity to hear from companies that have successfully

implemented Quality Metrics, and breakout sessions to discuss and share successful

implementation tips and preventing “unintended consequences”.

PDA is excited to add a regulatory perspective to this conference. This conference

is being co-lead by industry and FDA with the intent to broaden the discussion in

include potential regulatory aspects of Quality Metrics.

FDA will present their latest thinking on what they hope to achieve from Quality

Metrics and join in the dialog on discussing Quality Metrics in various breakout

sessions.

This will be a very interactive conference so come prepared for discussions on

Quality Metrics. This is an opportunity for PDA members to help shape new

potential regulatory requirements in the future.

Come join us for this timely and informative session on Quality Metrics, The

meeting will be held over a full two days at the Bethesda North Marriott, December

9-10, 2013.

Russell Wesdyk, OPS Scientific Coordinator, CDER, FDA and Program Planning Committee Co-chair

Steven Mendivil, Executive Director of Corporate Quality, Amgen, Inc. and Program Planning Committee Co-chair

www.pda.org/metrics2013 3

2013 PDA Pharmaceutical Quality Metrics ConferenceDecember 9-10, 2013 | Bethesda North Marriott Hotel & Conference Center | Bethesda, Maryland

Exhibition: December 9-10

Monday, December 9, 2013 Agenda

Sincerely,

7:30 a.m. – 6:30 p.m.Registration Open

7:30 a.m. – 8:30 a.m.Continental Breakfast

8:30 a.m. – 8:35 a.m. Welcome and Opening Remarks Steven Mendivil, Executive Director of Corporate Quality, Amgen, Inc. and Russell Wesdyk, OPS Scientific Coordinator, CDER, FDA Co-Chairs, 2013 PDA Pharmaceutical Quality Metrics Conference Program Planning Committee

8:35 a.m. – 10:15 a.m.P1: Opening Plenary: Executive Level on MetricsModerator: Anders Vinther, PhD, Vice President, Quality Biologics, Genentech, Inc.

Description: In this session FDA will give an overview of the objectives the agency has for companies to establish and report Quality Metrics as these relate to product quality, plant performance and the six inspection related quality systems. What is FDA looking for – and what not – in terms of reporting from companies, how may the quality metrics help companies, and what are the next steps FDA are planning on this topic. PDA is working on a white paper for quality metrics and the draft results of the work will be presented for further discussion. Finally, Industry experts will discuss how quality metrics has been or will be used at specified companies to continually improve the daily operations from a quality and reliable supply perspective. They will discuss how to move the needle towards better performance.

8:35 a.m. – 8:55 a.m.FDA OverviewRussell Wesdyk, OPS Scientific Coordinator, CDER, FDA

8:55 a.m. – 8:15 a.m.PDA WhitepaperSteven Mendivil, Executive Director of Corporate Quality, Amgen, Inc.

9:15 a.m. – 10:15 a.m.Panel Discussion: The Importance of Quality Metrics to Drive Continuous Improvement; How it can Move the Needle

Panelists:Greg Guyer, Senior Vice President, Global Quality, Merck Sharp & Dohme Corporation Fionnuala Walsh, PhD, Senior Vice President Global Quality, Eli Lilly and Company Martin VanTrieste, Senior Vice President, Quality, Amgen, Inc. Kathryn Wengel, Chief Quality Officer, Johnson and Johnson Other Industry Panel Representatives to be Announced

10:15 a.m. – 10:45 a.m. Refreshment Break in Exhibit Area

10:45 a.m. – 12:15 p.m.P2: Product Quality MetricsModerator: Anil Sawant, PhD, Vice President, Regulatory Compliance, Johnson and Johnson

Description: This session will discuss potential product specific metrics used within industry to objectively assess product quality. The goal is to understand whether differences exist between dosage forms, drug products, and drug substances. The session will also establish the foundation to identify what metrics can be used across diverse product types.

10:45 a.m. – 11:05 a.m.ParenteralsMarty Nealey, Vice-President of Operations, Plant Manager-Rocky Mount, Hospira

11:05 a.m. – 11:25 a.m.Solid DosageIndustry Representative to be Announced

11:25 a.m. – 11:45 a.m.Small Molecule APIIndustry Representative to be Announced

11:45 a.m. – 12:05 p.m.Biologic APIIndustry Representative to be Announced

12:05 p.m. – 12:15 p.m.Framework for Breakout SessionAnil Sawant, PhD, Vice President, Regulatory Compliance, Johnson and Johnson

12:15 p.m. – 1:30 p.m. Lunch

1:30 p.m. – 3:00 p.m.Breakout Session A – Product Quality Metrics(Attendees will be divided into small groups to discuss this topic which will be led by industry and regulatory facilitators)

Description: During the breakout sessions participants will discuss and develop recommendations on what data constitutes the critical few metrics that should be collected, how should the data be analyzed to convert it to meaningful information, and how should this information be converted to knowledge that can help firms improve Product Quality and FDA build its Risk Based Inspection Schedule.

INDUSTRY FACILITATORS:

Anil Sawant, PhD, Vice President, Regulatory Compliance, Johnson and JohnsonMarty Nealey, Vice-President of Operations, Plant Manager-Rocky Mount, HospiraAnders Vinther, PhD, Vice President, Quality Biologics, Genentech, Inc. Additional Industry Representative to be Announced

Breakout Session A – Product Quality Metrics (continued)


Monday, December 9 - Tuesday, December 10, 2013 Agenda

Breakout Session B – Site and Quality Systems Metrics (continued)


Joyce Bloomfield, Executive Director Global GMP Systems & Compliance, Merck Sharp & Dohme CorporationIan Elvins, President and Owner, Elvins and AssociatesSusan Schniepp, Vice President, Quality and Regulatory Affairs, Allergy Laboratories, Inc.Steven Mendivil, Executive Director of Corporate Quality, Amgen, Inc.

REGULATORY FACILITATORS:

Richard Friedman, Associate Director, OMPQ, CDER, FDA Faiad Rahaman, Operations Research Analyst, CDER, FDAAlex Viehmann, Operations Research Analyst, CDER, FDACarmelo Rosa, Supervisory Consumer Safety Officer, CDER, FDA Michael Smedley, Deputy Director, OMPQ,CDER, FDAJason Urban, PhD, Senior Staff Fellow, CDER, FDAAdditional Regulatory Facilitators to be Announced

6:30 p.m. – 7:30 p.m. Networking Reception

Tuesday, December 10, 20137:15 a.m. – 5:30 p.m.Registration Open

7:15 a.m. – 8:15 a.m.Continental Breakfast

8:15 a.m. – 10:00 a.m.P4: Culture and Comparing Metrics Moderators: Susan Schniepp, Vice President, Quality and Regulatory Affairs, Allergy Laboratories, Inc.Glenn Wright, Senior Director, Project Management Technical Services/Manufacturing Sciences, Eli Lilly & Company

Description: How do Quality Metrics drive the culture in a company? Can quality metrics from one product, one site, the company be compared with the quality metrics of another company? Can two companies with different cultures be compared using Quality Metrics? What happens when a company picks the wrong metrics? How can the wrong metrics drive unintended consequences? This session brings together Industry leaders to explore these questions through discussion and case studies and sheds light on the role senior leaders play on establishing a culture where quality performance thrives.



3:00 p.m. – 3:15 p.m. Refreshment Break In Exhibit Area

3:15 p.m. – 4:45 p.m.P3: Site and Quality Systems MetricsModerator: Joyce Bloomfield, Executive Director Global GMP Systems & Compliance, Merck Sharp & Dohme Corporation

Description: The objective of this session is to engage industry to discuss Plant/Site and quality system metrics that can be utilized for early detection of Plant/Site issues, to make effective risk management decisions and to continually improve Plant/Site performance. The first presentation will discuss the PDA Draft White Paper Facility related metrics and site metrics in general and give examples of how these might evolve. This will be followed by case studies which will demonstrate how these quality metrics can be used as predictive (leading) indicators of site and Quality Systems performance both at an individual site and to compare site to site performance in the same company for both OTC and RX sites.

3:15 p.m. – 3:45 p.m.Quality Systems as they Apply to FacilitiesAnders Vinther, PhD, Vice President, Quality Biologics, Genentech, Inc.

3:45 p.m. – 4:15 p.m.Inter/Intra-site Quality Metrics Case Study from an RX PerspectiveFionnuala Walsh, PhD, Senior Vice President Global Quality, Eli Lilly and Company

4:15 p.m. – 4:45 p.m.Inter/Intra-site Quality Metrics Case Study from an OTC/RX PerspectiveKathryn Wengel, Chief Quality Officer, Johnson and Johnson

5:00 p.m. – 6:30 p.m.Breakout Session B – Site and Quality Systems Metrics(Attendees will be divided into small groups to discuss this topic which will be led by industry and regulatory facilitators)

Description: The intent of these breakouts are to discuss, refine and select the top 5 quality metrics that best measure Plant/Site and QS performance. We will discuss the metrics themselves, how they should be measured and how trends and data can be used for effective decision making by site and company senior leaders.




Tuesday, December 10, 2013 Agenda (continued)


Glenn Wright, Senior Director, Project Management Technical Services/Manufacturing Sciences, Eli Lilly & CompanyMarty Nealey, Vice President of Operations, Plant Manager-Rocky Mount, HospiraJohna Norton, Vice President-Global QA API Manufacturing/PR&D, Eli Lilly and CompanyAnil Sawant, PhD, Vice President, Regulatory Compliance, Johnson and JohnsonSusan Schniepp, Vice President, Quality and Regulatory Affairs, Allergy Laboratories, Inc.Steven Mendivil, Executive Director of Corporate Quality, Amgen, Inc.



12:00 p.m. – 1:30 p.m. Lunch on your own

1:30 p.m. – 3:00 p.m.Breakout Session D – Culture(Attendees will be divided into small groups to discuss this topic which will be led by industry and regulatory facilitators)

Description: Can metrics be objective and independent of the culture of the organization or will the culture influence the outcome of the metrics? How can the culture of an organization influence the outcome of the metrics? This session will explore the relationship and close connection between metrics and culture.


Susan Schniepp, Vice President, Quality and Regulatory Affairs, Allergy Laboratories, Inc.Ian Elvins, President and Owner, Elvins and AssociatesMartin VanTrieste, Senior Vice President, Quality, Amgen, IncJoyce Bloomfield, Executive Director Global GMP Systems & Compliance, Merck Sharp & Dohme Corporation


Richard Friedman, Associate Director, OMPQ, CDER, FDA Faiad Rahaman, Operations Research Analyst, CDER, FDAAlex Viehmann, Operations Research Analyst, CDER, FDACarmelo Rosa, Supervisory Consumer Safety Officer, CDER, FDAMichael Smedley, Deputy Director, OMPQ, CDER, FDAJason Urban, PhD, Senior Staff Fellow, CDER, FDAAdditional Regulatory Facilitators to be Announced

3:00 p.m. – 3:15 p.m. Refreshment Break in Exhibit Area

8:15 a.m. – 8:45 a.m.The Importance of Quality Metric to Drive Continuous Improvement; How it can Move the Needle Part I Martin VanTrieste, Senior Vice President, Quality, Amgen, Inc.

8:45 a.m. – 9:15 a.m.The Importance of Quality Metric to Drive Continuous Improvement; How it can Move the Needle Part II Industry Representative to be Announced

P4: Culture and Comparing Metrics (continued)

9:15 a.m. – 9:45 a.m.The Importance of Quality Metric to Drive Continuous Improvement; How it can Move the Needle Part III Greg Guyer, Senior Vice President Global Quality, Merck

9:45 a.m. – 10:00 a.m.Framework for Breakout SessionsSusan Schniepp, Vice President – Quality and Regulatory Affairs, Allergy Laboratories, Inc.Glenn Wright, Senior Director, Project Management Technical Services/Manufacturing Sciences, Eli Lilly & Company

10:00 a.m. – 10:30 a.m. Refreshment Break In Exhibit Area

10:30 a.m. – 12:00 p.m.Breakout Session C – Comparison(Attendees will be divided into small groups to discuss this topic which will be led by industry and regulatory facilitators)

Description: Which quality metrics can be used to compare quality performance across products/sites/industry to identify areas of strength and areas where added focus may be needed? For these metrics, as the complexity of products and process often differ, what approaches can be used to account for this difference to allow them to be evaluated across products/sites/industry.


Tuesday, December 10, 2013 Agenda (continued)

Continuing Education Credits (continued)

Continuing Education CreditsThe PDA Training and Research Institute is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy

Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and submit the CPE credit request form to the registration desk following full attendance of this event. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

ACPE # 0116-0000-13-078-L04-P | 1.468 CEUsType of Activity: Knowledge

Learning Objectives: By participating in the two day conference, participants will gain current knowledge from industry and regulatory experts and be able to:

• Discuss and develop current thinking and best practices for Quality Metrics that promote continuous improvement and risk mitigation for drug shortages

• Collaborate firsthand with a diverse group of industry and regulatory representatives to identify possible drug shortage indicators

• Define steps forward for implementation and realization of metrics driving continuous improvement

Who Should Attend:Personnel from Quality, Supply Chain and technical functions with experience in this area will find this level of direct information exchange with members of industry and regulatory agencies useful to their specific programs and to improve more generally across the market.

DepartmentsResearch and Development | Regulatory Affairs | Manufacturing/Operations | Supply Chain and Business Risk Functions | Quality Assurance/Control

Job FunctionsSupply Chain | Executive Management | Clinical Supply Materials Preparation | Regulatory | Quality

General InformationThree Ways to Register1. Click www.pda.org/metrics20132. Fax +1 (301) 986-10933. Mail PDA Global Headquarters Bethesda Towers 4350 East West Highway, Suite 150 Bethesda, MD 20814 USA

Venue Bethesda North Marriott Hotel & Conference Center5701 Marinelli Road, Bethesda, MD 20852Phone: +1 (301) 822-9200

3:15 p.m. – 5:30 p.m.P5: Closing Plenary Session – Readout of Breakout Sessions/Panel DiscussionsModerators: Steven Mendivil, Executive Director of Corporate Quality, Amgen, Inc.Russell Wesdyk, OPS Scientific Coordinator, CDER, FDA

Description: This session will summarize the output from the four breakout Sessions (Product Quality Metrics, Site and Quality System Metrics, Quality Metric Utilization and Culture Aspects of Quality Metrics). FDA Facilitators will provide reactions and thoughts to the break out summaries. FDA Keynote presenter will describe the vision for the Quality Metrics and Oversight of Product Into the Future. The session will close with a final executive industry panel.

3:15 p.m. – 4:15 p.m.Breakout Session Readout Anil Sawant, PhD, Vice President, Regulatory Compliance, Johnson & JohnsonJoyce Bloomfield, Executive Director Global GMP Systems & Compliance, Merck Sharp & Dohme CorporationGlenn Wright, Senior Director, Project Management Technical Services/Manufacturing Sciences, Eli Lilly & CompanySusan Schniepp, Vice President – Quality and Regulatory Affairs, Allergy Laboratories, Inc.

P5: Closing Plenary Session – Readout of Breakout Sessions/Panel Discussions (continued)

4:15 p.m. – 4:35 p.m. FDA Panel Discussion

PANELISTS:

Richard Friedman, Associate Director, OMPQ, CDER, FDA Faiad Rahaman, Operations Research Analyst, CDER, FDACarmelo Rosa, Supervisory Consumer Safety Officer, CDER, FDA Michael Smedley, Deputy Director, OMPQ, CDER, FDA Jason Urban, PhD, Senior Staff Fellow, CDER, FDAAlex Viehmann, Operations Research Analyst, CDER, FDAOther FDA Representatives to be Announced

4:35 p.m. – 5:05 p.m.FDA UpdateFDA Keynote Presenter to be Announced

5:05 p.m. – 5:30 p.m.Executive Panel Discussion

PANELISTS:

Greg Guyer, Senior Vice President, Global Quality, Merck Sharp & Dohme Corporation Martin VanTrieste, Senior Vice President, Quality, Amgen, Inc. Fionnuala Walsh, PhD, Senior Vice President Global Quality, Eli Lilly and Company Kathryn Wengel, Chief Quality Officer, Johnson and Johnson Other Regulatory and Industry Representatives to be Announced

5:30 p.m.Adjourn




Page TitleWebsite: https://www.marriott.com

Rate: Single: $169.000, plus applicable state and local taxes.

Cut Off Date: Book your reservations by Friday, November 8, 2013. Rooms must be secured by this date in order to receive the PDA room rate.

Conference Registration HoursMonday, December 9: 7:30 a.m. – 6:30 p.m.Tuesday, December 10: 7:15 a.m. – 5:30 p.m.

Dress/AttireBusiness casual attire is recommended for the 2013 PDA Pharmaceutical Quality Metrics Conference. Since the temperature in meeting rooms tends to be cool, please bring a jacket or sweater for your comfort.

Special RequirementsIf you require special accommodations to fully participate, please attach a written description of your needs with your registration form. Specific questions can be directed to [email protected].

Contact InformationConference inquiries: Jason Brown, Senior Manager, Programs and Meetings Phone: +1 (301) 656-5900 ext. 131E-mail: [email protected]

Registration inquiries: Phone: +1 (301) 656-5900 ext. 115 E-mail: [email protected]

Exhibition/sponsorship inquiries: David Hall, Vice President, Sales Phone: +1 (301) 760-7373 Cell: +1 (240) 688-4405 E-mail: [email protected]

2013 PDA Pharmaceutical Quality Metrics ConferenceDecember 9-10, 2013 | Bethesda North Marriott Hotel & Conference Center Bethesda, MarylandExhibition: December 9-10

Registration is simple and fast... Click, fax or mail: Click: www.pda.org/metrics2013 Fax: +1 (301) 986-1093 (USA); Mail: PDA Global Headquarters, 4350 East West Highway, Suite 150, Bethesda, MD 20814 USA

1 Contact Information PDA Membership Number:

Campaign Code:

Prefix Name (Last, First, MI)

Job Title

Department Company

Mailing Address

City State/Province ZIP+4/Postal Code

Country Email

Business Phone Fax

Substituting for

(Check only if you are substituting for a previously enrolled colleague; The fee difference in the prevailing rate is due at the time of substitution. Please note that if you are a non-member substituting for a member, you will be required to pay the difference in the non-member fee.)

2 Conference Registration | December 9-10, 2013 Please check appropriate fee (US$).

Government/Health Authority Academic StudentPDA Member Nonmember Member Nonmember* Member Nonmember* Member Nonmember*

Before September 26, 2013 $ 1, 695 $ 1,944 $ 700 $ 800 $ 700 $ 800 $ 280 $ 310

September 26 – October 29, 2013 $ 1,895 $ 2,144 $ 700 $ 800 $ 700 $ 800 $ 280 $ 310

After October 29, 2013 $ 2,095 $ 2,344 $ 700 $ 800 $ 700 $ 800 $ 280 $ 310

* For this member type, online registration is not available and must be faxed in.

Please note: In order to receive the prevailing rate, your registration(s) with payment must be received by PDA by 5:00 p.m. ET on or before the date noted.

4 Payment Options All cards are charged in US$.

By Credit Card – Clearly indicate account number and expiration date and billing address. Please bill my: American Express MasterCard VISATotal amount $ Credit Card Guarantee Only

Account Number Exp. Date

Name (exactly as it appears on card) Signature

Billing address

City State Zip

Country

Wire Transfer Payments: If you require wire transfer, please contact PDA Registration at [email protected] or +1 (301) 656-5900 ext. 115.

CONFIRMATION: A letter of confirmation will be sent to you once payment is received. You must have this written confirmation to be considered enrolled in a PDA event. Please allow one week for receipt of confirmation letter. If you have submitted a purchase order or requested an invoice please be advised that a credit card guarantee is needed. Please be advised that if your payment or written cancellation notice is not received by October 10, 2013 your credit card will be charged the prevailing rate. SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including on-site at the prevailing rate. If you are a non-member substituting for a member, you will be required to pay the difference non-member fee. If you are pre-registered as a substitute attendee, indicate this on the registration form. REFUNDS: Refund requests must be in writing and faxed to +1 (301) 986-1093. (Emails and phone messages are not accepted). Refunds for Full Conference/Events: If your written request in received on or before October 10, 2013 you will receive a full refund minus a $200 processing fee. After that time, no refunds or credit requests will be approved. On-site registrants are not guaranteed to receive conference materials until all advanced registered attendees receive them. EVENT CANCELLATION: PDA reserves the right to modify the material or speakers/instructors without notice, or cancel an event. If an event must be canceled, registrants will be notified by PDA in writing as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA Registration at [email protected] or +1 (301) 656-5900 ext. 115. Refund for Courses: If your written request is received by November 11, 2013, you will receive a full refund less a $200 processing fee. After that time, no refunds or credit approvals will be made. COURSE CANCELLATION: PDA reserves the right to modify the material or speakers/instructors without notice, or to cancel an event. If an event must be cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. PHOTO RELEASE: By registering for 2013 PDA Pharmaceutical Quality Metrics Conference, I authorize PDA the right to photograph me and to use the photographs in all formats and media for any purpose, including for education, marketing and trade purposes. I hereby release PDA from all claims arising out of the use of the photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership.

PDA USE ONLY Date: Check: Amount: Account:

PDA Federal Tax I.D. #52-1906152

Special Dietary Requirements (Please be specific):

Group Registration: Register 4 people from the same organization as a group (at the same time) for the conference and receive the 5th registration free. Other discounts cannot be applied.

If you attended the PDA/FDA Conference or Investigations Workshop, you can get a 20% discount at the prevailing registration rate for the Metrics Conference.

I qualify for the 20% discount as a full paid attendee of the PDA/FDA Joint Regulatory Conference or the Investigations Workshop at the prevailing rate.* (Other discounts cannot be applied)

* Online registration is not available and must be faxed in at (301) 986-1093 or e-mailed in to [email protected].

3

2013 PDA Pharmaceutical Quality Metrics ConferenceDecember 9-10, 2013 | Bethesda North Marriott Hotel & Conference Center Bethesda, MarylandExhibition: December 9-10

Registration is simple and fast... Click, fax or mail: Click: www.pda.org/metrics2013 Fax: +1 (301) 986-1093 (USA); Mail: PDA Global Headquarters, 4350 East West Highway, Suite 150, Bethesda, MD 20814 USA

1 Contact Information PDA Membership Number:

Campaign Code:

Prefix Name (Last, First, MI)

Job Title

Department Company

Mailing Address

City State/Province ZIP+4/Postal Code

Country Email

Business Phone Fax

Substituting for

(Check only if you are substituting for a previously enrolled colleague; The fee difference in the prevailing rate is due at the time of substitution. Please note that if you are a non-member substituting for a member, you will be required to pay the difference in the non-member fee.)

2 Conference Registration | December 9-10, 2013 Please check appropriate fee (US$).

Government/Health Authority Academic StudentPDA Member Nonmember Member Nonmember* Member Nonmember* Member Nonmember*

Before September 26, 2013 $ 1, 695 $ 1,944 $ 700 $ 800 $ 700 $ 800 $ 280 $ 310

September 26 – October 29, 2013 $ 1,895 $ 2,144 $ 700 $ 800 $ 700 $ 800 $ 280 $ 310

After October 29, 2013 $ 2,095 $ 2,344 $ 700 $ 800 $ 700 $ 800 $ 280 $ 310

* For this member type, online registration is not available and must be faxed in.

Please note: In order to receive the prevailing rate, your registration(s) with payment must be received by PDA by 5:00 p.m. ET on or before the date noted.

4 Payment Options All cards are charged in US$.

By Credit Card – Clearly indicate account number and expiration date and billing address. Please bill my: American Express MasterCard VISATotal amount $ Credit Card Guarantee Only

Account Number Exp. Date

Name (exactly as it appears on card) Signature

Billing address

City State Zip

Country

Wire Transfer Payments: If you require wire transfer, please contact PDA Registration at [email protected] or +1 (301) 656-5900 ext. 115.

CONFIRMATION: A letter of confirmation will be sent to you once payment is received. You must have this written confirmation to be considered enrolled in a PDA event. Please allow one week for receipt of confirmation letter. If you have submitted a purchase order or requested an invoice please be advised that a credit card guarantee is needed. Please be advised that if your payment or written cancellation notice is not received by October 10, 2013 your credit card will be charged the prevailing rate. SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including on-site at the prevailing rate. If you are a non-member substituting for a member, you will be required to pay the difference non-member fee. If you are pre-registered as a substitute attendee, indicate this on the registration form. REFUNDS: Refund requests must be in writing and faxed to +1 (301) 986-1093. (Emails and phone messages are not accepted). Refunds for Full Conference/Events: If your written request in received on or before October 10, 2013 you will receive a full refund minus a $200 processing fee. After that time, no refunds or credit requests will be approved. On-site registrants are not guaranteed to receive conference materials until all advanced registered attendees receive them. EVENT CANCELLATION: PDA reserves the right to modify the material or speakers/instructors without notice, or cancel an event. If an event must be canceled, registrants will be notified by PDA in writing as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA Registration at [email protected] or +1 (301) 656-5900 ext. 115. Refund for Courses: If your written request is received by November 11, 2013, you will receive a full refund less a $200 processing fee. After that time, no refunds or credit approvals will be made. COURSE CANCELLATION: PDA reserves the right to modify the material or speakers/instructors without notice, or to cancel an event. If an event must be cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. PHOTO RELEASE: By registering for 2013 PDA Pharmaceutical Quality Metrics Conference, I authorize PDA the right to photograph me and to use the photographs in all formats and media for any purpose, including for education, marketing and trade purposes. I hereby release PDA from all claims arising out of the use of the photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership.

PDA USE ONLY Date: Check: Amount: Account:

PDA Federal Tax I.D. #52-1906152

Special Dietary Requirements (Please be specific):

Group Registration: Register 4 people from the same organization as a group (at the same time) for the conference and receive the 5th registration free. Other discounts cannot be applied.

If you attended the PDA/FDA Conference or Investigations Workshop, you can get a 20% discount at the prevailing registration rate for the Metrics Conference.

I qualify for the 20% discount as a full paid attendee of the PDA/FDA Joint Regulatory Conference or the Investigations Workshop at the prevailing rate.* (Other discounts cannot be applied)

* Online registration is not available and must be faxed in at (301) 986-1093 or e-mailed in to [email protected].

3

2013 PDA Pharmaceutical Quality Metrics ConferenceDecember 9-10, 2013 Bethesda North Marriott Hotel & Conference CenterBethesda, MarylandExhibition: December 9-10

Sponsorship and Exhibit Opportunities are Available!High impact, cost-effective sponsorship and exhibition packages are available for the 2013 PDA Pharmaceutical Quality Metrics Conference. Gain valuable exposure and connect with industry experts from Quality, Supply Chain, Operations, Manufacturing, Risk Management, Clinical Operations, Procurement and Regulatory Affairs.

The workshop agenda provides ample time for exhibitors to make new contacts and network with attendees who will be seeking current information on potential regulatory aspects of Quality Metrics. Exhibit at this conference to gain new business relationships, connect with key industry leaders and improve your company’s visibility.

In addition, comprehensive sponsorship packages will provide your company the opportunity to strengthen brand image and reinforce its commitment to the biopharmaceutical industry. Sponsorships are also available for lanyards, USBs, notepads, audience response systems, pens, refreshment breaks, lunch and networking reception.

For more information about exhibit and sponsorship opportunities, please contact:

David Hall, Vice President, SalesDirect: +1 (301) 760-7373 | Cell: +1 (240) 688-4405 | E-mail: [email protected] www.pda.org/metrics2013

PDA Global Headquarters4350 East West HighwaySuite 150Bethesda, MD 20814 USAPhone: +1 (301) 656-5900Fax: +1 (301) 986-0296

2013 PDA Pharmaceutical Quality Metrics Conference December 9-10, 2013 Bethesda North Marriott Hotel & Conference Center Bethesda, Maryland Exhibition: December 9-10 www.pda.org/metrics2013

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