Pharmaceutical Documentation - a practical approach

Course Dates: 17 & 18 June 2010

Course Venue: Central London UK (to be advised)

Course Cost: £1160.00 + VAT £174.00  (Total cost: £1334.00)

                          a reduced rate of £1044.00 + £182.70 VAT  (Total £1226.70) if booked and paid by

                     Friday 2 April 2010

Speakers: Dr Michael Gamlen, Pharmaceutical Development Services

                  Dr Pauline McGregor, PMcG Consulting

Course Objectives:

Documentation is the key to GMP compliance and traceability of all development, manufacturing and testing activities. Documentation provides the route for auditors to assess the overall quality of operations within a company and the final product.

This course provides explanation and examples of the key documents, required for pharmaceutical development, manufacturing processes, laboratory testing and also those required for CRM sections of a regulatory dossier. It illustrates how the documents are linked and controlled through the quality management system and provides useful tips for document control and management to keep them current.

The course provides a practical approach to master formula, batch records and laboratory controls and validation requirements. Documentation requirements for the qualification of instrumentation and equipment are also discussed; including validation protocols and validation reports.

 

The course material is presented in a dynamic environment by means of slides, handouts and participation of the attendees through discussion and hands on exercises. Who knew - documentation can be fun! 

 

Note: Participants are asked to bring an example of a document related to their work for the final session on Day 2)

The workshop emphasizes practical issues such as:

  • A hands on exercise to experience the document flow of the manufacturing process
  • Design a User Requirement Specification (URS)
  • Determine the specification for a drug product
  • Define an IQ/OQ protocol for analytical instrumentation

This course will deliver the tools to enable you to

  • Understand the importance of good documentation and how to apply it
  • Recognise and understand the key documents involved in Chemical and Manufacturing Control (CMC) processes.
  • Understand the role of these key documents and how they link together within the Quality Management System
  • Understand how product specifications are determined
  • Gain the skills and knowledge necessary to meet current regulatory expectations.
  • Understand the documentation requirements with regards to storage of  materials, sampling procedures, stability testing and qualification and training of personnel
  • Know the key documents associated with laboratory controls
  • Feel more comfortable with documentation on a daily basis
  • Improve the current approach to documentation within your company

 

During the course, the Good Products document management system will be available for review by the participants. This fully validated system offers a wide range of support systems for document management in the pharmaceutical development and manufacturing areas.

  

Who should attend?

This two-day course is valuable for all levels of staff who is involved in documentation as a daily activity in the pharmaceutical and related industries in the following areas:

  • Quality Assurance
  • Documentation and Technical Writing
  • Quality Control Laboratory
  • Regulatory Affairs
  • Qualified persons
  • Analytical Laboratory
  • Project Management
  • Research and Development
  • Production
  • Validation

Course outline:

Questions and answers will be taken throughout the duration of the course.

Day 1

8.30 Registration and Coffee

Morning Session 1 - 9.00 to 10.30am

  • Introduction – Why Document?
  • Quality management Systems

10.30 Morning refreshments

Morning Session 2 - 10.45 am to 12.45pm

Introduction to key documents and their relationships

  • SOPs
  • Protocols
  • Master Formulae

Exercise “Tasty Tablets”

Master production documents

  • Manufacturing Record
  • Packaging Record
  • Batch Records
  • Spoecifications

 

12.45 Lunch

Afternoon Session 1 - 13.45 to 15.15pm

Additional Manufacturing documents

  • Warehousing
  • Sampling
  • Weighing/dispensing
  • Batch Manufacturing records
  • Product testing and release

Training and qualification of personnel

 

15.15 Afternoon refreshments

Afternoon Session 2 - 15.30 to 17.30pm

Validation Documentation

  • Validation overview
  • Validation master plans

17.30pm End of day

  

Day 2

Morning Session 1 - 9.00 to 10.30am

Validation Documentation (continued)

  • User Requirement Specification (URS)

Exercise

  • Validation protocols
  • Equipment/Instrument Qualification (IQ/OQ/PQ)
  • Validation report

10.30 Morning refreshments

 

Morning Session 2 - 10.45 am to 12.30pm

Documentation in the Laboratory

  • GMP requirements of Laboratory notebooks, raw data and log books
  • SOPs
  • Certificate of Analysis
  • Test methods
  • Protocols and Reports

 12.30 Lunch

Afternoon Session 1 - 13.30 to 15.15pm

Documentation Control

  • Common elements and standards
  • Generation, review, approval
  • Numbering systems
  • Document Management
  • Summary to successl

Product development documentation in practice

  • Determining the specifications for drug product (case study)

 

15.15 Afternoon refreshments

Afternoon Session 2 - 15.30 - 17.00pm

Stability testing and documentation

Individual documents (participants are asked to bring an example of a document related to their work for this segment)

17.00pm End of day

 
 
 
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