Thursday September 2, 2010
Solid Dosage Production in cGMP Manufacturing
Principles, Practices and Strategies
February 24-25, 2010 - Montreal, Canada

An Interactive and Comprehensive One & Half-Day Course On:

  • Formulation and Production cGMPs
  • Pharmaceutical Mixing
  • Materials for Direct Compression
  • Formulation with Binders, Fillers, Glidants, Lubricants, and Disintegrants
  • Screening and Sieving - Particle size reduction
  • Dry Granulation and Wet Granulation
  • Fluid bed Technology
  • Tabletting Principles and Equipment
  • The Seven Stages of Compression
  • Maximum allowable Punch Tip Loading Overload systems.
  • Tablet Tooling –Elegant products are dependant on tooling design.
  • Challenges with concavity and engraving
  • Coating Principles and Equipment
  • Sugar Coating, Film Coating, Modified release Coating
  • Understanding colours, polymers and spray application
  • Encapsulation Principles and Equipment
  • Scale-Up and Technology Transfer Considerations
  • Problem solving and Troubleshooting
  • Future Trends and New Technology
Mr. Victor H. Shulman
President
Darvic Consulting Inc.
 

Victor Shulman is a third generation pharmacist with over forty years of international experience in GMP and industry compliance. He has gained hands-on experience at both brand name and generic companies. His projects have included redesigning of tooling engraving, implementation of aqueous ultrasonic cleaning, scale up, reformulation, SOP development, process validation, and process and efficiency improvement.

In January 1999 he decided to take semi-retirement to consult and train operators in the pharmaceutical industry. He currently lectures on Basic Pharmaceutics for operators at Seneca College’s Industrial Pharmaceutical Technology Department and at the Academy of Applied Pharmaceutical Sciences. His consulting activities include consulting for and making applications for site licences, for clients under the new Health Canada Health Food Directorate.

Victor is a registered Pharmaceutical Chemist and member of the Pharmaceutical Society of Great Britain. He holds a diploma in pharmacy from the Witwatersrand Pharmacy School and a diploma in production management.

Day 1 - Wednesday February 24, 2010
   
08:00 AM Registration and Continental Breakfast
08:30 AM - 04:00 PM Course Content
(10:30 AM - 10:45 AM
Mid-Morning Refreshment Break)

(12:00 PM - 01:00 PM Luncheon)

(02:30 PM - 02:45 PM
Mid-Morning Refreshment Break)

Regulatory Considerations

  • Review and discussion of cGMP’s
  • Regulations and goals for formulation and production

Mixing

  • Overview of Pharmaceutical Mixing
  • Three main types of Pharmaceutical mixes
  • Principles of mixing
  • Function of each ingredient in a mix
  • Materials for Direct Compression
  • Using Binders, Fillers, Glidants, Lubricants, Disintegrants
  • Screening and Sieving - Particle size reduction

Granulation

  • Why granulate?
  • Dry Granulation – (Roller Compaction, Chilsonation)
  • Wet Granulation - High Shear, Low Shear, Spray Granulation.
  • Fluid bed Technology – Granulation, Drying, Coating.

New Technology

  • (IBC) In-bin blending
  • benefits
  • elimination of cross contamination
  • cycle time reduction

Questions and Answers

Tabletting

  • Principles and Equipment Utilized in Tabletting
  • The Seven Stages of Compression
  • Functions & stages of the tablet compression process
  • Tight punches, Weight Variation, Capping, Sticking
  • Maximum allowable Punch Tip Loading Overload systems
  • Problem solving - general troubleshooting

Tablet Tooling

  • Achieving correct concavity and correct engraving
  • Sticking and friable tablets
  • Creating even force distribution
Questions and Answers
04:00 PM Conclusion of Day One
   
Day 2 Thursday February 25, 2010
   
08:00 AM Continental Breakfast
08:30 AM Coating
(10:30 AM - 10:45 AM
Mid-Morning Refreshment Break)

(12:00 PM - 12:45 PM
Luncheon)
  • Principles and Equipment Utilized in Coating
  • Sugar Coating
  • Film Coating
  • Modified Release Coating
  • Understanding colours, polymers and spray application
  • Troubleshooting

Encapsulation

  • Principles and Equipment
  • Soft-shell Manufacturing
  • Hard-shell Manufacturing
  • Troubleshooting

Questions and Answers

03:00 PM Conclusion of Program

This one and half day course is suitable for Directors, Managers, Supervisors, Associates in the Pharmaceutical, Biopharmaceutical, Vitamins, Herbals, and allied industries with daily responsibilities in the following areas:

  • Manufacturing
  • Product Development
  • R&D – Product Submission
  • Quality Control
  • Quality Assurance
  • Regulatory Affairs
  • Analytical Laboratory
  • Documentation and Technical Writing
  • Project Management
  • Technical Reviewers
  • Validation
  • Training

Special group rates available for three or more registrants. Some restriction applies.

3 easy ways to register!
Mail:
International Pharmaceutical Academy
420 Highway# 7 East, Box 82022
Richmond Hill, Ontario
Canada L4B 3K0
Fax:
(905) 472-1819

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Solid Dosage Production in cGMP Manufacturing $565.00 CAD + GST
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Registration Fee Includes: Presentation Materials, Luncheon, and Refreshments

Cancellation/Substitutions Policy: CANCELLATION POLICY: Cancellation is accepted in writing (by mail, or fax) up to 4 weeks before the program start date, after which cancellations are not accepted and do not qualify for refund or credit. All Cancellations are subject to a $210.00 CAD (incl. GST)/person processing fee. Substitution of delegate/s with the member/s of the same organization is permitted at any time. IPA reserves the right to postpone an event, prior to which time all the registered attendees will be notified a minimum of 2 weeks in advance. IPA shall not be responsible for any air fare, hotel or transportation costs incurred by registrant/s.

Hilton Garden Inn
Montreal Airport
7880 Cote-De-Liesse
Montreal, Quebec, Canada H4T 1E7

Tel: +1-514-788-5120
Fax: +1-514-788-5025

A special room rate has been prearranged for conference participants. Call the hotel directly at the above number and mention IPA to receive the reduced room rate. 

For more information, please call us at 416-410-7402 or enquiry@ipacanada.com

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