C1C: GMP Clearance - Addressing Application Deficiencies
Tracks
Courtyard Room Seminar
| Tuesday, November 19, 2024 |
| 11:00 AM - 11:30 AM |
Details
TGA staff often identify several deficiencies or areas requiring clarification during the evaluation of GMP Clearances. Sending Requests For Information (RFI) or Proposal to Not-Issue (PNI) can add significant time onto your applications.
In this seminar, learn about common issues encountered in both the Mutual Recognition Agreement (MRA) and Compliance Verification (CV) pathways to reduce the likelihood of receiving an RFI/PNI in your next application.
Speaker: Peter Kroek, GMP Evaluator, GMP Clearance Section
Peter made the move to Canberra and joined the TGA as an evaluator in the GMP Clearance section in mid-2023, following 5 years in production and quality assurance roles at an aseptic compounding facility. Peter's experience also includes radiopharmaceuticals and compounding at sites in Australia and the United Kingdom, and time as a minerals processing engineer at mining operations around the country.
Speaker: Marguerite Walcott-Taylor, GMP Evaluator, GMP Clearance Section
Marguerite joined the TGA as an evaluator in the GMP Clearance section in May 2022. Prior to joining the TGA, Marguerite has worked in production, quality control and quality assurance for pharmaceutical and medical device manufacturing companies, over the last 10 years.
In this seminar, learn about common issues encountered in both the Mutual Recognition Agreement (MRA) and Compliance Verification (CV) pathways to reduce the likelihood of receiving an RFI/PNI in your next application.
Speaker: Peter Kroek, GMP Evaluator, GMP Clearance Section
Peter made the move to Canberra and joined the TGA as an evaluator in the GMP Clearance section in mid-2023, following 5 years in production and quality assurance roles at an aseptic compounding facility. Peter's experience also includes radiopharmaceuticals and compounding at sites in Australia and the United Kingdom, and time as a minerals processing engineer at mining operations around the country.
Speaker: Marguerite Walcott-Taylor, GMP Evaluator, GMP Clearance Section
Marguerite joined the TGA as an evaluator in the GMP Clearance section in May 2022. Prior to joining the TGA, Marguerite has worked in production, quality control and quality assurance for pharmaceutical and medical device manufacturing companies, over the last 10 years.
