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Practical Pharmaceutical Manufacturing

A TWO-DAY COMPREHENSIVE & INTERACTIVE MULTIMEDIAL COURSE THAT BRINGS VIRTUAL EQUIPMENT INTO THE CLASSROOM
Receive a Credit toward the Diploma program in Pharmaceutical Quality Control or Professional Regulatory Affairs

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Distinguished Faculty

Victor H. Shulman
President
Darvic Consulting Inc .

3RD GENERATION PHARMACIST WITH OVER 40 YEARS INDUSTRIAL EXPERIENCE IN INDUSTRY & GMP COMPLIANCE Diploma in Pharmacy from the Witwatersrand Pharmacy School - Equivalent to a B.Pharm Degree Registered Pharmaceutical Chemist and Member of the Pharmaceutical Society of Great Britain Damelin Management School of South Africa - Diploma in Production Management.

Learned the art of Pharmaceutical production with 10 years “hands on” experience in South Africa. Immigrated to Canada in 1975 and worked for various Pharmaceutical companies BOTH Brand name & Generic.
In January 1999 - decided to take Semi-retirement to consult and Train Operators in the Pharmaceutical Industry.

Special Projects completed

  • Development and delivery of Training Modules in Basic Pharmaceutics for Operators in Mixing, Tabletting, Tabletting Troubleshooting, Encapsulation, Coating, Improved Product Elegance. (Presented these modules in Canada & USA for “Pharmaceutical Production Techsource” As well as presenting these modules to train Health Canada Inspectors.
  • Development of a Tablet Maintenance Section for Tooling Cleaning, Inspection, & measurement. Re-design of tooling engraving to enhance product elegance and eliminate Production Problems such as Capping, Sticking & Weight Variation as well as improving Coating elegance.
  • Introduction of aqueous Ultrasonic cleaning for Punches and Dies.
    • Implementation of a Database Driven Program to measure Tablet Tooling (T.I.A.S.)
  • “DROPS program” (Document Reduction and Optimisation of Manufacturing Processes). Implementation of a Database Driven Program to re-write and update Master Formulae from standardised text and codes.
  • Scale up from pilot to manufacturing batch sizes, Troubleshooting, Method Study and Improvement Implementation, reformulation of marginal products to facilitate more cost effective runs on high-speed machinery.
  • Eliminated slugging as a process and replaced this with roller compaction. 
    (Chemical Processing July 1987 - Roll Compaction System cuts changeover time and increases productivity by up to 75% - Victor Shulman & Alan Hodel)
  • Elimination of Wet Granulation by changing to Directly Compressible or roll compacted formulae by initiation of particle size studies with data collection on particle size & geometry to establish flow properties and general physical characteristics of Raw Materials and Granulations
  • Process Validation and writing of User Friendly Standard Operating Procedures using an action verb followed by a brief description together with Photo Scans to eliminate verbiage and clarify SOP’s.
  • Currently lecturing Basic Pharmaceutics at Seneca College - (Industrial Pharmaceutical Technology Department) and at AAPS ( Academy of Applied Pharmaceutical Sciences)
  • Currently consulting for and making applications for site licences for clients under the new Health Canada Health Food Directorate.
    Pharmaceutical Sciences)
  • Currently consulting for and making applications for site licences for clients under the new Health Canada Health Food Directorate.

Registration Fee Includes

Presentation Materials, Luncheon, Refreshment and Free Parking

Note: Please indicate any special Dietary requirements when registering for the course

Dates Available

April 19-20, 2012

Time

8:30 a.m - 5:00 p.m.

Cost

CAD $885.00 + HST

Location

AAPS Training Center
200 Consumers Road, Suite 200, Toronto, Ontario, M2J 4R4
Tel: 416-502-2277

Abstract

This intensive two-day comprehensive course, provides participants with a solid understanding of the principles behind the Solid Dosage manufacturing process. The course starts with a consideration for regulatory aspects affecting formulation and production of pharmaceutical products and progresses to various aspects of powder and granulation technology, formulation of solid dosage forms, manufacturing processes and equipment including scale-up and technology transfer as well as the key regulatory constraints that must be considered at each stage. The course shares experience from “Hands on” manufacturing and product scale up offering participants with up-to-date knowledge of the current practices and future trends in the field.

Course Outline

Who Should Attend

This two-day course is valuable for Directors, Managers, Supervisors, Associates in the Pharmaceutical, Biopharmaceutical, Vitamins, Herbals, Medical Devices and allied industries with daily responsibilities in the following areas:

Agenda - Day One

8:30 am - 9:00 am
Registration & Continental Breakfast

9:00am – 9:05am 
Opening Remarks

9:05am -10:45am 
Practical Pharmaceutical Manufacturing

10:45am -11:00am 
Mid-Morning Break

11:00am – 12:45pm 
Practical Pharmaceutical Manufacturing Cont’d

12:45pm -1:45pm 
Luncheon

1:45pm – 3:30pm 
Practical Pharmaceutical Manufacturing Cont’d

3:30pm – 3:45pm 
Afternoon Break

3:45pm – 5:00pm 
Practical Pharmaceutical Manufacturing


Agenda - Day Two

8:30am - 9:00am 
Continental Breakfast

9:00am -10:45am 
Practical Pharmaceutical Manufacturing Cont’d

10:45am -11:00am 
Mid-Morning Break

11:00am – 12:45pm 
Practical Pharmaceutical Manufacturing Cont’d

12:45pm -1:45pm 
Luncheon

1:45pm – 3:30pm 
Practical Pharmaceutical Manufacturing Cont’d

3:30pm – 3:45pm 
Afternoon Break

3:45pm – 5:00pm 
Practical Pharmaceutical Manufacturing

Certificate of Attendance and Course Material