Quality Agreements in the Pharmaceutical Industry
It is a GMP requirement that written agreements exist between all parties in the pharmaceutical supply chain for outsourced activities. The purpose of these agreements is to clearly define the responsibilities and expectations of each party to ensure the supply of safe medicines to the consumer and set up an efficient recall process in the event something goes wrong. The quality agreement provides the basis for knowledge transfer and communication between parties throughout the supply chain.
This webinar provides an overview of regulatory guidelines for Quality Agreements in the pharmaceutical industry. It also discusses formats and content for agreements between various outsourced activities.and includes common mistakes with agreements and a practical component to help you customise your own agreements based on your company outsourced activities
Time is given to allow questions and answers throughout the webinar to help attendees personalize their agreements based on their companies needs.
The material is based on FDA, European and Health Canada guidance’s for Outsourced activities.
• Overview of regulatory requirements
• Observations highlighting deficiencies in quality agreements
• Which format should I choose?
• Personalizing the quality agreement based on company needs
Participants are encouraged to bring their own example of a draft quality agreement to work on during the practical section of the webinar
Who Should Attend?
This webinar is valuable for personnel at all levels, who participate in writing or reviewing Quality Agreements in the pharmaceutical industry
What’s included with the webinar?
Each participant will receive:
- A certificate of attendance upon completion
- An electronic copy of the presentation and relevant handouts relating to the webinar if applicable.
- A microsoft word template of a Quality Agreement
Pauline McGregor PhD. CChem, MRSC has fulfilled a variety of roles in over thirty years in the pharmaceutical industry. She is an expert in quality systems and procedures, GMP regulations and analytical chemistry.
Pauline has the experience and ability to customize and install the quality systems required to allow new manufacturing and testing companies to operate to GMP regulations and review and improve on current quality systems to allow more efficient operations.
She has utilized her skill set globally in the UK, Canada, US, Jordan, Brazil, and China and has helped companies prepare for a GMP inspection to gain their European/Health Canada/FDA GMP licenses
|Course Date||Dec-08, 2020 9:00 am|
|Course End Date||Dec-08, 2020 12:00 pm|
|Registration Start Date||Oct 14, 2020|
|Cut off date||Dec 07, 2020|
|Course Leader||Pauline L. McGregor, Ph.D. CChem, MRSC|