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 (other than QA) or senior management. It it is often an uphill battle for QA to implement effectively.
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 inspections of various systems and processes, 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 their questions for the Question and Answer session.
- Compliance issues, barriers and weaknesses
- Tips for success
- Harnessing 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 or redesign 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.
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 for companies as an extension of their quality group.
As a USP volunteer, Pauline was a proud member of the initial USP expert panel for Validation, Verification and Transfer of Analytical Procedures and a member of a USP Chemical Medicines Monograph expert review committee. She continues to be a US expert volunteer. Pauline is also a member of The Royal Society of Chemistry, UK and is listed on their current directory for consultants.
|Course Date||Nov-13, 2020 9:00 am|
|Course End Date||Nov-13, 2020 12:00 pm|
|Registration Start Date||Oct 14, 2020|
|Cut off date||Nov 12, 2020|
|Course Leader||Pauline L. McGregor, Ph.D. CChem, MRSC|