Welcome to PMcG Consulting
Blue Sky Approach - Down to Earth Solutions

Unfortunately, all in class training programs and workshops have been cancelled due to the COVID 19 out break. Please observe your local governments advice to keep you and your families safe and healthy.
Changes to PMcG operations until the COVID-19 situation is resolved: 

1) Reduced rates on online or telephone consulting sessions
2) Discounted document writing and review service
3) New Professional webinars to help increase efficiency of your operations/processes 
Contact us for a customised quote for the above services.

Check out our interactive knowledge sharing industry webinars during April and May!

 

Start your week on a positive note and give your brain a boost!  Sign up and drop in every Monday from April 27th through May 18th. We hope to boost those grey cells, make you laugh and not feel so alone! 10.00am EDT (Duration approx. 20 minutes).

Everyone is welcome!  Last Session May 18th.- It's a Brain Blast!

Are you getting the most from your self inspection program?

More often than not the self inspection program happens once a year and bogs down QA resources.
Also, the program does not always have the support or respect from personnel or senior management and it is an uphill battle for QA to implement effectively.
In actual fact the self inspection program is one the most powerful tools you have in your Quality Management System toolbox. Unfortunately, I find it is seldom set up to its maximum potential.
I have found over the years that attaching a schedule to a self inspection program is something people are reluctant to commit to or try to make it as vague as possible.
And yet within your schedule and frequency of inspection of various systems, lies the opportunity to unleash the power of the program and make the inspection program work for you, your company and your resources.

If designed properly the self inspection program can add value to your business, by determining, measuring and identifying opportunities and threats relating to continual improvement of operations as well as being a compliance tool . When integrated properly with other quality systems It can improve operational effectiveness, efficiency and overall governance.

This webinar offers advice on how to get the most from your self inspection program.

 Participants are encouraged to bring thier questions for the Question and Answer session.  


Webinar Outline

  • Compliance issues, barriers and weaknesses
  • Tips for success
    A respectful and helpful culture
    Defining the scope of the program, the schedule and frequency of inspections
  • The Process of self-inspection
    Planning (the audit team, checklists and tips for success)
    The inspection (tips for success)
    Assigning remedial actions and improvements
    Closing the audit (Records and report)
    Follow up and monitoring for effectiveness
  • Wrap up
  • Q and A Session

Who Should Attend?

This Webinar is valuable for personnel at all levels who participate in the self inspection program either as an inspector or are inspected. Particularly informative for Quality Assurance personnel writing their intial self inspection program or those wishing to improve their current one. Suitable for Pharmaceutical and related industries. Those involved in continual improvement for business as well as compliance will also benefit. 

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. 

Course Leader

Pauline McGregor, PhD. CChem MRSC has over 30 years experience in the pharmaceutical industry.

She is an expert in quality systems and procedures, GMP regulations and analytical chemistry. 

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. She is often asked to perform self inspections as an extension of their quality group.

Pauline was a member of the USP expert panel for Validation, Verification and Transfer of Analytical Procedures and is currently on a USP Chemical Medicines expert committee. Pauline is also a member of The Royal Society of Chemistry, UK and is on their current directory for consultants.

Course Properties

Course Date May-21, 2020 11:00 am
Course End Date May-21, 2020 12:30 pm
Registration Start Date Apr 08, 2020
Cut off date May 19, 2020
Individual Price $255.00
Course Leader Dr. Pauline McGregor, Ph.D. Chem, MRSC
This course is currently not available:  Notify Me When a Course is Scheduled
$255.00 100

Contact PMcG Consulting directly for your in-house GMP training needs. Explore our website for all in-house training topics

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.