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17/18 June 2010
Venue Central London (tba)
Speakers Michael Gamlen & Pauline Mc Gregor
Cost £1334 (inc VAT)
Early-bird rate £1226.70 (inc VAT)
if booked and paid by 2 April 2010
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Available as an in-house course
Overview
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 are 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
