COURSES

3rd ANNUAL TRAINING PROGRAM ON

FORMULATION & PROCESS DEVELOPMENT FOR ORAL DOSAGE FORMS

"A 5-Day Modular and Case Study Oriented Training Program"

April 23 - 28, 2006, Nassau Inn, Princeton, New Jersey
Historical Location, Reputable Speakers & Innovative Program

 

 
PROGRAM

SPEAKERS

ABSTRACTS

COURSE EVALUATION

MISCELLANEOUS

REGISTRATION

 


Description  //  Schedule  / / Registration Fee and Accommodation  / / Further Information

Innovative Modular Format
Crystal Form of APIs // Preformulation // General Formulation & Process Development Guidelines

Milling, Mixing, and Flow  // Granulation  // Tableting/Compaction //Film Coating // Technology Transfer  //Stability

Critical/Current Issues
Solubility; Polymorphism; Stability; Formulation Development Strategies; Selection of excipients (Functionality Considerations);
Process, Scale-Up, Trouble Shooting;  SUPAC,  Validation, and PAT Related Issues;   Identifying and dealing with stability issues.

Description

PTI Inc., is offering a comprehensive training program "Formulation & Process Development For Oral Solid Dosage Forms" that will have its Second Annual Session between  April 23-28, 2006.  Please review the previous (2004-2005) course evaluations for this event by visiting   Course Evaluations   in order to have an opinion whether this program can meet your expectations or not.

Description of the Program:

This is a pragmatic program that will be presented in a modular format and will deal with various aspects of those unit operations that are intended to produce pharmaceutical tablets. The modular format will allow participants to focus attention on key activities in which they are interested, as well as provide a broad overview of the key technical aspects associated with tablet development.

 

The nature of the ingredients that are typically used in tablet formulations, the complexities of their interactions, and the impact of material properties on those interactions will be reviewed. Guidelines will be given with respect to both formulation and process development activities. Each of the important unit operations involved in preparing tablets will be discuss

 

Who Should Attend

This is not intended to be an introductory program for individuals generally unfamiliar with the design and development of oral solid dosage forms. The program will thus be of greatest value to scientists that are currently involved with tablet formulation and process development, and who wish to gain a greater understanding of the key issues that are critical to the preparation of robust tablet dosage forms.

 

Learning Objectives

Having completed this program, participants will have a greater understanding of the key issues that are fundamental to the design and preparation of a quality product that can complete a successful technology transfer process. This understanding will not only encompass a better appreciation for the role of the raw materials used, but also the part that process technology plays in the ultimate commercialization of tabletted dosage forms.

 

Distinctive features of the program

 

The format of this program will be much different from others that are currently offered in the pharmaceutical industry.

·          Unique, customizable modular format: The program will be in modular format, with each module being approximately 3-4 hours long and self contained in terms of content. Participants will be invited to select only those modules that they wish to attend, although we will expect them to select a minimum of five (out of a total of nine).

·          Lectures by internationally recognized instructors: We believe that the extensive knowledge and experience of our entire faculty will contribute immeasurably to the success of what we consider to be a program without equal in the industry today.

·          Two - three hour interactive evening sessions: We also plan to present two-hour evening sessions that will build on the subject matter of the modules presented earlier in the day, and will be in the form of case studies designed by the faculty, that are very much interactive in concept

·          Interactive discussions: Interactive discussions with advance input from the participants will be held in the evening sessions.

Schedule

 

 Day

Morning

Afternoon

Evening

Sunday

April 23' 06

 

 

 Registration & Welcoming Reception

Monday

April 24' 06

Crystal Form of APIs

Preformulation

Interactive

Discussions

Tuesday

April 25' 06

General Formulation &
Process Development

Guidelines

Milling, Mixing
and Flow

SPECIAL TOPIC:
1.
Use of AI Based Expert Systems As PAT Tools
2. Risk Analysis: A Critical COmponent of PAT

Wednesday

April 26' 06

Granulation

Tableting/
Compaction

DINNER WITH PARTICIPANTS

Thursday

April 27' 06

Film Coating

Technology
Transfer

SPECIAL TOPIC:
 FDA’s FAST TRACK APPROVAL or QbD

Friday

April 28' 06

Stability

 

 

Sunday, April 23rd, 2006

Evening Session:  

 

Registration & Welcoming Reception

DAY 1.   Monday, April 24th, 2006

Morning Session - Module 1:   Crystal Form of APIs

Issues:            Solubility; polymorphism; processibility; stability
Presenters:     Prof. David J.W. Grant  & Dr. Harry G. Brittain          

Afternoon Session - Module 2: Preformulation

Issues:           Physico-chemical & mechanical properties of APIs & excipients
Presenters:    Dr. Navnit H. Shah & Dr. Dukchoi Soon

Evening Session:     Interactive discussions and case studies
 

DAY 2.   Tuesday, April 25th, 2006

Morning Session - Module 3:  General Formulation & Process Development Guidelines

Issues:            Formulation development strategies; selection of excipients (functionality considerations); importance of multi-functionality of excipients; Impact of excipients on stability and bioavailability; defining potential processing steps; potential SUPAC & and PAT related issues

Presenters:    Dr. A. Waseem Malick  & Dr. Metin Çelik

Afternoon Session - Module 4: Milling, Mixing and Flow

Issues:            Materials, process, scale-up, trouble shooting, SUPAC and PAT related issues

Presenters:     Mr. Benjamin K. Murugesu  & Mr. James K. Prescott

Evening Session:     Presentation and Discussions on PAT TOOLS

 

DAY 3.   Wednesday, April 26th, 2006 

Morning Session - Module 5: Granulation

Issues:                 Materials, process, scale-up, trouble shooting, SUPAC and PAT related issues

Presenters:         Mr. Dilip M. Parikh & Mr. David M. Jones,

Afternoon Session - Module 6: Compaction

Issues:            Materials, process, scale-up, trouble shooting, SUPAC and PAT related issues

Presenters:     Dr. Metin Çelik & Mr. Gary Bubb

Evening Session:    A Night Out - Dinner with participants

 
DAY 4.   Thursday, April 27th, 2006 

Morning Session - Module 7:   Film Coating

Issues:                Materials, process, scale-up, trouble shooting, SUPAC and PAT related issues

Presenters:     Dr. Esay Okutgen & Dr. Stuart C. Porter

Afternoon Session - Module 8: Technology Transfer

Issues:               Materials, process, scale-up, trouble shooting, SUPAC and PAT related issues

Presenters:      Dr. Russ Somma and Dr. Hashim Ahmed

 

Evening Session:    Presentation and Discussions on Risk Analysis - A Critical Component of PAT

 

DAY 5.   Friday, April 28th, 2006

 

Morning Session - Module 9:   Stability

Issues:                Establishing an appropriate stability program; Identifying stability issues; designing formulations to maximize stability; dealing with stability problems

Presenters:     Prof. Lynne S. Taylor and Dr. Harry Brittain

Interactive discussions and case studies for module 9 will be a part of the morning session.

Important Note:

Please note that there may be an inevitable change in the program (such as replacement of a speaker) due to any reason.  In such a situation, we will spend every effort to keep the high standard of this program, however PTI Inc will not be hold liable for any consequences of such a matter.

 

Please also bear in mind that one of the important features of this training program is that we intend to have a very fruitful, comprehensive, and interactive sessions in which, all participants will have ample opportunity to seek answers for the questions that they might have about the modular sessions of the day.  In order to maximize the quality and utilizations of these sessions, we will contact every person after his/her registration is complete and ask him/her to provide us with the questions that they seek answers about the sessions that they will attend.  We will then pass these questions to the speakers. 

Registration Fee and Accommodation

Registration:

Please bear in mind that one of the important features of this training program is that we intend to have a very fruitful, comprehensive, and interactive evening sessions in which, all participants will have ample opportunity to seek answers for the questions that they might have about the modular sessions of the day.  In order to maximize the quality and utilizations of these evening sessions, we will contact every person after his/her registration is complete and ask him/her to provide us with the questions that they seek answers about the sessions that they will attend.  We will then pass these questions to the speakers.  Also, if they wish to do so, the participants will be able to make short presentations in the evening sessions, as well.  Therefore we strongly recommend anybody who would like to make a short presentation, to register for this training program well in advance so that we can assist in providing uniform presentations of the highest quality possible

Registration Fee:

 

  Minimum 5 Modules  Each Additional Module  All 9 
Modules
Per Person  $ 2,000.00  $ 350.00  $ 2,750.00
Per person (If 3 or more register per company at the same time)  $ 1,800.00  $ 315.00  $ 2,475.00

 

Cancellation Fee:  25% of the registration fee will be withheld after January 15, 2006. There will be no refund after February 15, 2006. Substitution of individual participants will be permitted.  Please note that the registration fee includes the presentation materials for the session, as well as continental breakfast, lunch and refreshment breaks during the program.

On-Line Registration:

Click here for On-Line Registration Form:    Registration  

Location/Accommodation:

 

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Historical Nassau Inn located in Princeton, New Jersey.  Since 1756, the Nassau Inn has been a gathering place of distinction, well known for its gracious hospitality and elegant facilities.  From its convenient location in the heart of downtown Princeton, to its rustic ambience and sophisticated charm, the historic Nassau Inn is of one of the New Jersey's premier hotels.

Shuttle Service is available between the Hotel and the Newark - NJ and JFK - NY airports (Call Nassau Inn at 1-609-921-7500 for the details).  Visit   www.nassauinn.com   for further information.

Room Rates:

$ 152.00 per night for early registration.  There may not be any guarantee for the rate or availability of the rooms after March 23, 2006 this date (Subject to Change).  

 

Please mention your affiliation with Pharmaceutical Technologies International (Booking ID: 5098 or Group Name: PTI Conference) at the time of your reservation to get the guaranteed rate. Rates can not be changed at check-in or checkout for attendees who have failed to mention their affiliation at the time their reservation was made (Subject to Change).  

Further Information

For Further Information or comments on our training programs please contact:
 

 

 E-MAIL

PHONE

FAX

Training Programs

Training@pt-int.com

1-908-864 0555

1-908-864 0556

Dr. Metin Çelik

Metin.Celik@pt-int.com

1-908-864 0555

1-908-864 0556

Dr. Stuart C. Porter

porter@pt-int.com

1-215-362 4868

1-215-393 8830

PTI, Inc.
Mailing Address

Regular Mail

 PO Box 186, Belle Mead, NJ 08502, USA

Overnight Mail

 22 Durham Road, Skillman, New Jersey, 08558 USA

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