Available as an in-house course

Tablet Process Development and Validation

Course dates                                                           

13 & 14 October 2008                                                                                                                                                           

Venue

to be advised

Duration
2 days

Cost

£1160 + £203 VAT = Total £1363.00

(A reduced rate is available if booked with the course "Integrated Tablet Formulation Development")

A 10% discount rate is applied if booked by Friday 8 August 2008

Overview

Workshop objectives

The goal of this workshop is to provide detailed information on the validation and qualification of manufacturing processes for tablets and

capsules including process control, problem solving and documentation for FDA and other regulatory inspection.

By the end of the workshop, you will

Understand the purpose of tablet process validation, and the relationship between tablet formulation, tablet process development and tablet process validation

Understand the processes commonly used to manufacture tablets

and capsules, and the factors which affect them

Gain practical guidance on how and why Quality Assurance and

Quality Control functions should be involved in tablet process validation

Know how to identify critical processing parameters and how to control the process

 Who will benefit from the course?

Tablet formulation and process development staff and those involved in commissioning products into production.  Regulatory Affairs staff preparing dossiers for tablet products.  Quality Assurance personnel responsible for the design or implementation of tablet process validation protocols

Numbers  will  be  limited to give  participants  the opportunity for thorough

discussion  of  the  issues  to  be covered  by  the programme  and  one  on

one consultation with speakers. 

Course speaker
Dr Michael Gamlen

Programme

• Day 1

  8.45     Registration and coffee

  9.15     Introductions

                       - Tablet formulation development

                          Understanding the relationship between manufacturing formula and process

                          How are processes and formulas arrived at?

                          How are they controlled?

         10.45      Coffee

         11.15     -  Key Manufacturing processes - purpose, equipment and control (1)

                          Blending and lubrication

                          Dry Granulation - Roller compaction and slugging

                          Wet Granulation

         12.30      Lunch

         14.00     - Blending for direct compression

                          We follow the development of a formulation from hand filled capsules to production tablet

                          manufacture, reviewing blending options and actual results

                          FDA requirements for blend uniformity assessment

         15.00      - Blending scale-up and segregation

         15.30      Tea

         16.00      - Key manufacturing processes - purpose, equipment and control (1)

                          Drying

                          Sieving

                          Tablet compression

                          Film coating

          17.00     End of Day 1

• Day 2

            9.00     - Process Control Case study - Granulation end point control

                           How can we control granulation processes?

                           End point selection

                           How do granule properties relate to key processing parameters?

          10.00       Coffee

          11.00      - Scale up of high speed mixer granulation

                           Segregation                  

                           Capping

                           How to address these problems?

                           Including mixing, granulation and compression problems

          12.00      - Documentation of Process Development

          12.30       Lunch

          14.00      - Quality control in tablet manufacture

                            Assuring tablet quality during and after manufacture

          14.30      - Principles of validation

                            Regulatory guidance on validation - FDA and EU

                            What is the purpose of Process Validation and where does it fit in the quality system, and

                            product transfer

                            Pre-Approval Inspections  (PAIs) and process qualification

           15.30      Tea

           16.00      - Developing process validation protocols

                            Planning  and developing protocols based on process development data

           16.30      Summary and Q & A

           17.00      End of Course