1. The PDA Southern California Chapter is Proud to Present:
Q1 2014 Educational Event - Thursday, February 27, 2014
“Making Sense of the New Extractables & Leachables Best
Practices for Parenteral Products… Blueprint for Success!
A
Presented by: Dr. Michael Ruberto, Material Needs Consulting
Presentation Overview:
The container closure systems (CCS) used for packaging and delivery of parenteral pharmaceutical products must not
adversely interact with the drugs to affect their safety or quality. Chemicals from packaging components, whether
constructed from glass, metal, plastic, or rubber, can migrate or leach from materials into drug product. For years,
established procedures for the safety evaluation of parenteral packaging systems involved antiquated compendial
methods along with best practices established for inhalation products utilizing conservative thresholds and extraction
conditions to mimic the solvating power of drug formulations very different from parenteral products. Recently, the
United States Pharmacopeia (USP) published draft general chapters recommending a three stage approach to establish
suitability for use of packaging materials using a combination of enforceable and informational general chapters, which
includes a major modernization of USP <661> entitled “ Plastic Packaging Systems and Their Materials of Construction”
along with the publication of two new chapters:
- USP <1663> “Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems” and
- USP <1664> “Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems”.
Furthermore, the Product Quality Research Institute (PQRI) has published new “best practices” for performing
extractables and leachables assessments on parenteral and ophthalmic drug products. This presentation provides a
summary of these newly issued documents, defines specific requirements and recommended methodologies for
extractables and leachables testing for parenterals, and a common sense novel approach that will:
- Establish a partnership between vendors of CCS and pharmaceutical companies
- Efficiently design extractables and leachables study plans
- Minimize the risk from unexpected packaging leachables or contaminants from shipping and storage
- Ensure a manageable supply chain

2. The PDA Southern California Chapter is Proud to Present:
Q1 2014 Educational Event - Thursday, February 27, 2014
“Making Sense of the New Extractables & Leachables Best
Practices for Parenteral Products… Blueprint for Success!
A
Presented by: Dr. Michael Ruberto, Material Needs Consulting
Speaker Bio: Dr. Michael Ruberto, Materials Needs Consulting
Dr. Michael Ruberto is the President of Material Needs Consulting, LLC which
provides consulting services to manage the development and commercialization of
medical devices, pharmaceutical products and packaging, with a special emphasis
on material selection, extractables and leachables, and supply chain management.
He has been an active member of various pharmaceutical working
groups that
have developed “best practices” for characterizing and evaluating the safety of
container closure systems and packaging for several different drug dosage forms.
Some of these teams include: PQRI Orally Inhaled and Nasal Drug Product E&L Working Group PQRI Parenteral and
Ophthalmic Drug Product E&L Working Group United States Pharmacopeia (USP) Packaging and Storage Expert
Committee.
Dr. Ruberto was formerly the Head of Regulatory Services for the NAFTA region at Ciba Specialty Chemicals where he
was responsible for world wide notifications of new products, food contact notifications, and regulatory compliance
of Ciba chemicals. He also designed leachable and extractable studies for the FDA approval of medical devices,
packaging, and labels used on drug containers. Dr. Ruberto was previously the Director of Analytical Research, where
he led a full service analytical laboratory that specialized in performing testing associated with the development and
commercialization of new products including chemical characterization, migration studies, applications support, and
technical service. Dr. Ruberto was employed by Ciba for fifteen years where he has performed numerous migration
studies to support FDA and European Union indirect food contact notification for various additives, pigments, and
polymers. He was part of a team commissioned to establish a Good Laboratory Practice (GLP) and Good
Manufacturing Practices (GMP) program in Ciba’s Analytical Research Department and served as GLP Study Director
for many product characterization and Base Set studies needed for global product registration of novel additives. Dr.
Ruberto received a B.S. with thesis from Stevens Institute of Technology and a Ph.D. in Analytical Chemistry from
Seton Hall University.

3. PDA Event Registration Details
Thursday, February 27, 2014
“Making Sense of the New Extractables & Leachables Best
Practices for Parenteral Products… Blueprint for Success!
A
Presented by: Dr. Michael Ruberto, Material Needs Consulting
All those who wish to attend must register (including site employees) for the event
prior to 02/24/14. Late registrations will incur a $10.00 fee.
Register and Pay Online by clicking the interactive PDA logo here:
Or, visit www.pda.org/southerncalifornia “upcoming events”
*PDA Members: in order to register online members will need their log-in user name
and password.
If you are not able to register online, PDA accepts faxed registrations with credit
card payment attention to: Trevor Swan/Katie Ruiz (301) 986-0296, or ruiz@pda.org.
Complete the form and mail to the address listed below. (if paying by check)
“Southern California Chapter of the PDA”
Attention: Brian Underhill, BioSPEQ/PDA
3200 El Camino Real, Suite 230
Irvine, CA 92602
Cancellations: Money is nonrefundable if cancellations are made after 02/24/14.
*Exhibitor Opportunity Fees are noted on the “Exhibitor Registration Form”. Note,
one attendee is included with Exhibitor Fees; additional exhibitor attendees must
register using regular registration form on the next page.
For additional information, please contact John Holmgren at (714) 246-5562.
Event Locations
All locations will be tied in via webex and audio feed. Food and beverages will be provided at each venue.
Amgen (LA County) *Live Speaker - One Amgen Center Dr. Thousand Oaks, CA 91320
Avid Bioservices (Orange County) - 14282 Franklin Avenue, Tustin, CA 92780
Carefusion (San Diego County) - 3750 Torrey View Ct, San Diego, CA 92130

4. CHECK OR CREDIT CARD
Attendee Name:
Title:
Company:
Business Address:
City / State / Zip:
Business Phone:
Fax Number:
Email Address:
Event Locations:
Amgen
Avid Bioservices
Attendee Early
Registration Fees:
$40.00- PDA Member
Submitted on or before
02/24/14
Carefusion
$30.00- Government Employee
$65.00- Non-PDA Member
$15.00- Student
Free- (Amgen, Avid Bioservices, or Carefusion Employees)
Late Registration Fees:
$10.00- Additional Charge to Regular Registration Fee Listed Above
After 02/24/14 or Walk-In
Mail Check Payments Payable to:
Southern California Chapter of the PDA
Attention: Brian Underhill, BioSPEQ/PDA- 3200 El Camino Real, Suite 230, Irvine, CA 92602
For Visa, MC, or American Express Payments, fax completed registration form to PDA, Trevor Swan/Katie
Ruiz at 301-986-0296, or email to ruiz@pda.org . Incomplete forms will not be processed.
Name as it appears on credit card: _____________________________
Total to be charged on card: $_____________
Credit Card Billing Address: _______________________City: _________State:
Card Number: _____________________________Expiration Date: ___________
Signature: _____________________________ Date: _______________
Zip Code:

5. CHECK OR CREDIT CARD
Exhibitor Name:
Title:
Company:
Business Address:
City / Sate / Zip:
Business Phone:
Fax Number:
Email Address:
Event Locations:
Exhibitor:
Amgen
Avid Bioservices
Carefusion
$300.00, for one location (includes: 1 attendee, additional attendees
must use regular registration form)
$500.00, for two locations (includes: 1 attendee for each location,
additional attendees must use regular registration form)
$700.00, for three locations (includes: 1 attendee for each location,
additional attendees must use regular registration form)
Mail Check Payments Payable to:
Southern California Chapter of the PDA
Attention: Brian Underhill, BioSPEQ/PDA- 3200 El Camino Real, Suite 230, Irvine, CA 92602
For Visa, MC, or American Express Payments, email completed registration form to PDA, Stephanie
Powers Kurtz at spowerskurtz@sterile.com . Incomplete forms will not be processed.
Name as it appears on credit card: _____________________________
Total to be charged on card: $_____________
Credit Card Billing Address: _______________________City: _________State:
Card Number: _____________________________Expiration Date: ___________
Signature: _____________________________ Date: _______________
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