Improving GLP QA in the coming Decade

Why Should You Attend:

This webinar is designed for QA, management and Study Directors to begin to view the role of QA in pre-clinical programs differently. It will provide the group with ideas that can be implemented within the organization to help drive quality and compliance improvement into the coming decade. This will ensure that the company is prepared for the coming changes by the FDA and other world organizations with regard to compliance programs in the pre-clinical space. Not being prepared can lead to both regulatory issues and company relevance moving into the future.

For the past decade I have seen QA groups move more in the direction of reactive to issues within the organization instead of being proactive within the organization. The adage that it is “management’s responsibility to make the change and our job is to bring it to their attention” no longer applies. QA needs to be the driver of change and quality improvement within an organization in order for management to see value in the group beyond a regulatory requirement. With the proposed changes to the GLPs being reflective of cGMP type systems, pre-clinical QA groups need to move beyond to old way of doing things and develop a much more proactive approach to quality and compliance within the organization.

Areas Covered in the Webinar:

• What I have seen in the industry as a consultant.
• What as the FDA been seeing in the industry.
• How QA can become the driver of quality and regulatory change.
• Where QA groups have failed to lead within the organization.
• Proposed improvements to the QA inspectional program.
• Proposed improvements between QA and Management.
• Examples of things which did not work and reason for failure.
• How to develop a quality action plan (QAP) for 2020.

Who Will Benefit:

• QA professional, management and Study Directors from the Pre-clinical space for pharmaceutical, medical device and biotechnology including CROs

Free Materials:

• Reference documents
• Rule documents or guidance
• Checklist
• SOP template
• Easy fill in forms
• Articles

Richard L Streeton
President, RLS Consulting

Richard Streeton has over 32 plus years of experience in the Pharmaceutical, Medical Device and Biotechnology fields. He has been responsible for Quality Assurance and Quality Systems for both GLP and cGMP (Drug and Device) operations at both CROs and Pharmaceutical and Medical Device Companies. Mr. Streeton has been a member of SQA since 1988. As a member of SQA Mr. Streeton served on the planning committee from 1994-1997 and was one of the original co-chairs in 1997. Mr. streeton served on the tellers committee from 1997-1998 and was part of Mentor Program from 2009-2010. He served on reginal chapter as Board of Directors for MARSQA (‘94-’95) and Planning Committee 1996-1997. He served as Vice President to Past President for the re-start of NERCSQA from 2000-2002 and served a second term of Vice President to Past President from 2017-2019. Mr. Streeton has been presenting at SQA meeting and Regional Chapter meeting since 1991 and has been published through SQA. Mr. Streeton was also an original member of the now defunct International Society of Quality Assurance (ISQA) and a Fellow of the British RQA since 2002.

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