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Strategies for Formulations Development - How to Get the Right Data in the Right Amount at the Right Time

Mar 27 - Mar 28, 2019 |
Mar 28, 2019 |
PDA Training and Research Institute | Bethesda, MD
  • Education
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Duration: 2 days
Time: 8:30 a.m. - 4:00 p.m.

This course will help scientists and engineers working on formulation development to be successful, developing formulations quickly and efficiently. Good strategies are needed to get the right data in the right amount at the right time.

Key takeaways include how to:

  • Approach formulation development from a strategic viewpoint, with the overall end in mind
  • Design screening experiments to identify components that are most important to the performance of the formulation
  • Design optimization experiments to identify the optimum responses in the design space
  • Analyze both screening and optimization experiments using graphical and numerical methods
  • Create formulation design spaces and perform associated risk analysis
  • Optimize multiple criteria, such as the quality, cost, and performance of product formulations
  • Designing and analyzing formulation studies that involve both formulation components and process variables using methods that reduce the required experimentation by up to 50%
  • Reduce mistakes, meet deadlines, avoid wasted experimentation and reduce the cost of experimentation in terms of time, personnel and funds

Learn how to speed up the formulation development process by producing quality formulations in a timely manner. This includes focusing on the development of strategic approaches, and taking a broad view of formulation using screening designs and investigating formulation components and process variables in the same experimental program.

Who Should Attend

  • R&D Executives, Leaders and Managers
  • Formulation Scientists and Engineers
  • Those who desire to use Quality by Design in Formulation Development
  • Lean Six Sigma Black Belts and Statisticians working with design teams
  • Chemists and Chemical Engineers
  • Process and Manufacturing Engineers
  • Quality Control and Assurance personnel
  • R&D personnel working in the pharmaceutical and biotech industries

Prerequisites

Participant should have science and/or engineering education or experience.

Upon completion of this course, you will be able to:

  • Develop strategies and associated experiment designs for formulation development
  • Design and analyze screening experiments involving a large number of components that will identify components with major effects
  • Develop ability to construct, conduct and interpret optimization studies
  • Select and utilize graphical procedures that will effectively display results and the effects of formulation ingredients
  • Minimize the number of experiments needed to study simultaneously the effects of process variables and formulation ingredients

Standard

Member

On or Before February 10, 2019
$1,889

After February 10, 2019
$2,099

Nonmember

On or Before February 10, 2019
$2,267

After February 10, 2019
$2,519


Government/Health Authority/Academic*

$1,259

*For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Special Accommodations and Dietary Requirements
If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact registration@pda.org or +1 (301) 656-5900. SUBSTITUTION: If a substitution request is sent by February 25, 2019, no fee will be charged. After February 25, 2019, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee. REFUND: If a refund request is sent by February 25, 2019, a full refund will be given minus a $200 fee. After February 25, 2019, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to registration@pda.org. Phone messages are not accepted.

General Course Information

Please arrive at the course location approximately thirty minutes before the start of the course to sign in. Please be sure to bring your confirmation letter as proof of registration. PDA will not allow persons to attend a course without payment, or guarantee of payment.

Breakfast will be served thirty minutes before the class begins. Lunch will be provided between 12:00 - 1:00 p.m.

Location

The course will be held at:

PDA Training and Research Institute
Bethesda Towers
4350 East West Highway, Suite 110
Bethesda, MD 20814 USA

Recommended Hotel

Hilton Garden Inn Bethesda
7301 Waverly Street | Bethesda, MD 20814 | 0.3 miles from PDA
(301) 654-8111

Contact

For more information, please contact:

Kimberly McIntire
Manager, Education
Tel: +1 (301) 656-5900 x103
Email: mcintire@pda.org

Ron Snee, PhD, President, Snee Associates, LLC.

Ron Snee is Founder and President of Snee Associates, LLC, a firm dedicated to the successful implementation of process and organizational improvement initiatives. He provides guidance to senior executives in their pursuit of improved business performance using Quality by Design (QbD), Lean Six Sigma and other data-based improvement approaches that produce bottom line results. He has played a leadership role in 32 major improvement initiatives for firms such as Merck, Novartis, Schering Plough, Human Genome Sciences, Celgene, Boehringer-Ingelheim and Kraft Foods. Ron recently authored three books on QbD topics including his latest book “Strategies for Formulations Development”, with Roger W. Hoerl of Union College (GE retired).

Ron also serves as Adjunct Professor in the Temple University School of Pharmacy and Rutgers University Pharmaceutical Engineering Program. Prior to entering the consulting field he worked at DuPont for 24 years in a variety of assignments including pharmaceuticals, statistical studies, manager of statistical, software and engineering consultants and process improvement.

He received his BA from Washington and Jefferson College and MS and PhD degrees from Rutgers University. He is an academician in the International Academy for Quality and Fellow of the American Society of Quality, American Statistical Association, and American Association for the Advancement of Science. Ron has been awarded ASQ’s Shewhart, Grant and Distinguished Service Medals, and ASA’s Deming Lecture and Dixon Statistical Consulting Excellence Awards as well as numerous other awards and honors. He is a frequent speaker and has published 6 books and more than 300 papers in the fields of performance improvement, quality, management, and statistics. Ron is a recent recipient of the Institute for Validation Technology’s Speaker of the Year Award.

 

Continuing Education for Pharmacists

ACPE PDA 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 mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

PDA #536 | ACPE #0116-0000-17-026-L04-P | 1.2 CEUs
Type of Activity: Application

Continuing Education for Professional Engineers

New Jersey

PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

The credit value of this course is 12 CPC credits.

North Carolina

PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDHs) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

The credit value of this course is 12 PDHs.

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