ANNUAL CANADIAN GMP REFRESHER TRAINING
TARGETED TO PHARMACEUTICAL LABORATORY PROFESSIONALS & RELATED QUALITY SYSTEMS
Don’t Break the Budget on Training your Team!!!
Get your team up-to-date with the latest GMP regulations and requirements by attending this cost-effective online GMP Training program.
Specifically written for testing laboratories, this one-day cost-effective online GMP Training program delivers current regulations to more than satisfy annual GMP refresher training requirements.
In addition to an overview of the principles of GMP and fundamental GMP requirements for laboratories, participants will gain practical knowledge of equipment and test procedure qualification, data governance data integrity, ALCOA plus principles and good documentation and record-keeping practices. An insight into the quality management system and related quality systems is also included. Bonus material includes some good housekeeping tips to ensure the laboratory remains in compliance.
Program Outline:
- Introduction to and history of GMP compliance
- Core Principles and Benefits of GMP Compliance
- Personnel: Qualifications, hygiene, and training requirements
- Equipment: Qualification, Maintenance and Calibration
- Testing raw materials, finished product and impurities
- Requirements for Contract Testing Laboratories
- Additional Laboratory Controls
- Good housekeeping tips to ensure the laboratory remains in compliance
- GMP Data Integrity Compliance Requirements
– Data Governance
– Data Integrity and ALCOA plus principles
– Good Documentation Practices - Introduction to the Quality Management System and Related Quality Systems
– Change Control
– OOS/OOT results
– Deviations and Non Conformance
– CAPA
– Self-Inspection - Overview and Summary
Dr. Pauline McGregor
Ph.D., C.Chem., MRSC
Dr. Pauline McGregor, PhD. CChem has fulfilled a variety of roles in over thirty five years in the pharmaceutical industry. She is an expert in quality systems and procedures, GMP regulations and analytical chemistry. Her experience in these roles has enabled her to become involved in troubleshooting and improving manufacturing processes and test procedures through her validation programs, investigations of OOS results, evaluation of changes/improvements to the process, and risk management.
She is a renowned trainer in her areas of expertise, a valuable consultant, and a detailed oriented auditor. She has utilized her skill set globally in the UK, Canada, US, Jordan, Brazil, and China.
Pauline was a proud member of the USP expert panel for Validation, Verification and Transfer of Analytical Procedures and a member of a USP Chemical Medicines monograph review committee. Pauline is a member of The Royal Society of Chemistry, UK.
This refresher program is designed for Directors, Managers, Supervisors, Analysts and Quality personnel working in pharmaceutical, biopharmaceutical, and allied industries.
It is particularly valuable for professionals involved in documentation, technical writing, performing analytical testing, documentation, data review, and training. Additionally, consultants and other stakeholders who collaborate with external laboratories will benefit from this comprehensive overview of GMP requirements and compliance.
- Understand the fundamental principles of Good Manufacturing Practices (GMP) and their significance in ensuring compliance testing of pharmaceutical
- Understand the different needs of validation, verification and transfer of analytical procedures.
- Know how to manage equipment qualification, maintenance and calibration program in a compliant manner.
- Recognize how to link data integrity, good documentation and record keeping practices and ALCOA plus principles to ensure reliable, compliant
- Recognize how to integrate laboratory practices with and quality assurance needs to remain in compliance
Registration Fees: $350 + HST
GROUP DISCOUNT REGISTRATION: Please contact us by email: enquiry@ipacanada.com or call 416-410-7402.
All participants will receive e-certificate of attendance upon completion of this online training.
CLICK HERE TO REGISTER!
Please note: IPA Virtual Trainings/Events registration fees are per person basis / per login, whether delegates are attending together from a conference room or from separate locations. Once registered, you will receive a unique login. This login can only be used by the registrant and can not be shared with anyone and no Recording at anytime during the event.
