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 Check out the interactive, knowledge sharing industry webinars during November and December 2020!

Unfortunately all in-house training sessions have been cancelled for the remainder of the year due to the Covid -19 pandemic

Contact us to customize an interactive and discussion format webinar to suit your company's training needs

Note:  All webinars are currently being delivered using a Zoom platform. If you are interested in a webinar and cannot access Zoom or Skype for Business, please contact us. 

Thanks to all who participated in one or more of the Social Brain Break sessions. They were lots of fun! Watch this space for the return of this popular event

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.

 Webinar Outline

Overview of regulatory requirements
• Observations highlighting deficiencies in quality agreements
• Which format should I choose?
• Personalizing the quality agreement based on company needs
• Summary

 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

Course Leader

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 Properties

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
Individual Price $345.00
Course Leader Pauline L. McGregor, Ph.D. CChem, MRSC
$345.00 100

Have you considered a customised, interactive and discussion format webinar? Contact PMcG Consulting directly for your in-house training needs.

Pauline McGregor is a member of the Royal Society of Chemistry and is listed on the RSC Directory of Consultants

Recommendations

  • Pauline is keen and hardworking, she loves her sciences and passionate about what she does. I so much enjoyed working with her, she has provided great insight on many technical and scientific issues related to analytical method development and analytical method validation. Her most important quality is her patience and perseverance and of course, fun to work with
  • Contracted Pauline to assess analytical methods validation, and to subsequently create a 'gap' report - and then to work at 'fixing' the gap. Pauline was excellent in her attention to detail, and her thorough knowledge of what was needed. She also worked on several projects after that one - always with the same high standards and commitment to provide value to the client. I heartily endorse her work.
  • Pauline is an excellent professional in the life science business. She did a great job as project manager in analytical development and validation at SGS Life Science Services. She was appreciated by her colleagues and her customers.
  • Pauline's ability to understand and integrate the scientific challenges of industry, with government and academia are unsurpassed. I am so confident with her ability to deliver meaningful yet pragmatic leadership as it applies to the pharmaceutical industry that I have recommended her to numerous prominent companies who have subsequently hired her and been extremely happy with the results she is able to deliver.