Good manufacturing practices are critical to everyday operations in the pharmaceutical industry. The basic principles of GMP are to assure the quality, potency, identity, safety and purity of products and to protect both the consumer and the company.
This course provides a refresher of Good Manufacturing Practices based on current Health Canada and FDA guidelines. It bridges the gap between the black and white regulations and everyday operations by describing the regulations and the practical application of them through key quality system elements, essential to GMP compliance. The course material is presented by means of slides, handouts and participation of the attendees through discussion and group exercises.
Hands-on exercises enable participants to map their individual GMP responsibilities and gain the skills and knowledge necessary to understand and work in a GMP compliant environment and contribute to the ongoing quality of their company.
The course is presented in a dynamic environment created by a power point presentation, interactive exercises, and group discussion. The final session includes a fun, team trivia quiz
This is a 1 day course geared towards a general audience with a range of experience and job descriptions. Individual questions are addressed throughout, and interactive exercises are designed to allow maximum benefit to all regardless of experience.
These are customized to suit the licensed GMP operations within your company. Can be presented as refresher training, new employee training, job specific GMP training or a training session to address deficiencies noted by regulatory authorities, customer audits or your internal self- inspection program.
This course is designed to provide essential training for conducting Out of Specification (OOS) investigations in a GMP laboratory.
The focus will be on those results generated during laboratory testing including a step-by-step approach on how to conduct and document an OOS result investigation in compliance with an regulatory audit.
The documentation required to support the OOS investigation is presented but the majority of time is spent detailing the who, what, when, how and why of the investigation, documenting findings and determining root causes to identify if the OOS is valid or can be assigned to analyst or laboratory error. Corrective and preventative actions are also discussed. An introduction to OOT (Out of Trend) results with respect to analytical and compliance alerts related to the laboratory is included, using industry examples
The course provides ample opportunities for group discussions, case studies and exercises. It enables participants to gain the skills and knowledge necessary to meet current regulatory expectations. The course material is based on the FDA guideline 'Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production', October 2006, FDA audit observations and the MHRA guidelines published in 2017.
Participants are welcome to bring their own examples for group discussion sessions.
This course is not applicable to Microbiology methods.
The workshop emphasizes practical issues such as:
• What is an OOT?
• GMP documentation (quality systems) required to support OOS investigation
• FDA audit observations and how they could have been avoided
• Investigation approach and tips for success
• Case studies for OOS results
• A detailed guide to conducting Phase 1 of the OOS investigation
• Reporting and evaluating passing and failing results
• Corrective and Preventative actions
• Minimising future OOS
Data Integrity is paramount for traceability of data and events occurring in the lifecycle of a product. It applies equally to both paper and computerized based systems. Although its main area of application is in the laboratory and manufacturing, it also applies to quality systems, the generation and review of records and ongoing monitoring of data management throughout the GMP activities across the supply chain.
Regulatory Agencies require written procedures for all systems and operations which impact the quality and safety of pharmaceutical products. Standard Operating Procedures (SOP’s) provide the main forum for the documentation of a Company’s systems and operations. SOP’s are therefore among the main documents audited by Regulatory Agencies during GMP inspections to ensure they reflect current practices and are followed as written.
The course reviews regulatory authorities’ expectations and guidelines relating to SOP’s and their role in global harmonization, good documentation practices and GMP. It then launches into a series of topics, interactive exercises and group discussion on how to write effective SOP’s and manage and maintain this critical documentation system. This course provides helpful information associated with the writing, formatting, execution and management of SOP’s. The course material is presented by means of slides, handouts and participation of the attendees through discussion and group exercises.
It enables participants to gain the skills and knowledge necessary to meet the FDA, Health Canada’s and other regulatory agencies’ expectations for SOPs.
This 2-day training course integrates the following principles of QbD and the lifecycle management approach to analytical procedures into current practices (Development, verification and transfer) to improve and maintain the performance of analytical procedures:
• Knowledge gathering
• The acceptance criteria target profile
• The Analytical Control strategy (identifying and controlling the appropriate method parameters)
• Risk Assessment Tools
• The qualification process (demonstration, the procedure meets the ATP requirements)
• Monitoring analytical procedures for acceptable performance throughout its lifecycle.
A fun, hands on practical component using a Statapult has been designed to demonstrate setting a target profile, investigating and controlling variables for the procedure and qualifying the procedure against the predetermined target.
Case studies are included for development of a new procedure, a method transfer and a verification of a compendial monograph procedure.
Although the material is based on HPLC for small molecules, the principles taught and the practical session, may also be applied to analytical procedures for large molecules.
This workshop is based on ICH Q8, Q9, Q10 and Q11 which have been adapted to suit analytical procedures. It also provides an update on the proposed new chapter ICHQ14 (Analytical Procedure Development), proposed updates to ICHQ2 (Analytical Validation).
Benefits/advantages to attending this course are:
• Improve performance of analytical procedures
• Improve understanding of your analytical procedures
• Reduce the number of OOS results due to poor method performance
• Increase success of transfer or verification analytical procedures
• Reduce non-value-added activities during investigations, development, verification and transfer
• Improve knowledge transfer and communication
• Keep up to date with best practices and guidelines for analytical procedures
This 1-day course is aimed at Quality Assurance auditors (or potential auditors) who work in a GMP environment. The course considers your roles both as an auditor and an auditee.
As part of GMP compliance a company should have internal and external audit programs operating as part of an integrated quality system. Internal audits are designed to consider quality and risk management principles to ensure ongoing GMP compliance and identify quality improvements. External audits ensure any outsourced activities or suppliers conform to your companies GMP requirements. This course also helps you to prepare for audits form regulatory authorities.