SeerPharma’s training division grows from strength to strength with several companies requesting tailored on-site QA/GMP training for staff. Recently a major multinational pharmaceutical manufacturer approached SeerPharma to address the following key areas of interest for staff at their firm:
- Global regulations
- Good report writing
- Key quality assurance system requirements (including auditing)
- Good Laboratory Practice
- Process validation/design of experiment requirements
- Analytical method validation requirements
- Biological assay validation & control requirements
- Data Integrity
In response SeerPharma tailored a 4-day training package for the firm addressing these needs, and customising our content to work with the client's existing business practices.
Day 1
The Regulated Environment (2 hours)
- List the major GMP regulatory bodies worldwide (briefly)
- State the difference between Regulations, Guides & Codes (briefly)
- Assess the current status of International MRAs and MOUs (briefly)
- Describe how governments regulate products and manufacturers in relation to the client's business
- State the essential requirements for GMP compliance in relation to the client's business
Good Report Writing (1.5 hours)
- Good writing practices and translating this into effective report writing
- Why effective report writing is important
Key Quality Assurance System Requirements (3.5 hours)
- What is a Pharmaceutical Quality System?
- Quality Risk Management
- Key Quality System Elements for Continuous Improvement
- Failure Investigation and Deviation Management
- Change Control
- Product Quality Reviews (PQRs)
- The importance of auditing (internal and suppliers)
Day 2
Good Laboratory Practice requirements (3 hours)
- The key elements and basic principles that make up GLPs and GMP in a testing laboratory and production environment
- The importance of records, raw data, traceability and documents to Quality Systems
- Your role and responsibilities regarding GLP and GMP compliance
Process Validation/Design of Experiment requirements (4 hours)
- Requirements for demonstrating that specific products and processes consistently meet predetermined specifications
- The current approach of PIC/S GMP Annex 15
- The life-cycle approach
- A roadmap for process validation
- Tools and templates for process validation
- Design of Experiments (DoE)
Day 3
Analytical Method Validation requirements (4 hours)
- Performance parameters required for analytical method validation
- Acceptance criteria for analytical method performance parameters
- Requirements for inter-laboratory method transfer
- Calculating the capability of a test method
Biological Assay Validation & Control requirements (3 hours)
- Identify biological assay method validation criteria
- Prepare a validation plan for a microbial limits test method
- Viral applications
Day 4 (half day)
Data Integrity (3.5 hours)
- Integration of DI into your QMS using a risk-based approach
- Protection and security of raw data and original records
- Control of your data when utilising vendor third parties
- Developing practical audit and remediation strategies for DI
With a bank of content that has been developed and over 30 years, SeerPharma is well-placed
to tailor and deliver QA/GMP training sessions to your staff on-site.
For more information on our most commonly requested courses to run on-site, please
visit: https://www.seerpharma.com/services/qa-and-gmp-training/on-site
Contact us to learn how we might be able to assist with your internal training needs.
