- Date: September 27, 2019
- NOTE: This seminar recurrs tri-monthly (every three month) on 4th Fridays.
- Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
- Time: 11:00 AM PST | 02:00 PM EST
- Duration: 60 Minutes
About the Seminar
In healthcare business environments, it is critical to define, document and implement an effective standard operating procedure (SOP) to ensure relevant business practices are done in a consistent, reliable, and effective manner – each and every time. Implementing an effective SOP has been under-valued by business owners for various reasons (e.g., due to perception for no need).
Effective SOPs can significantly help healthcare business owners save an enormous amount of time, energy, financial resources and beyond.
This webinar is intended to help you develop and implement guidelines for developing and implementing an effective SOP using a CAC-SI method. CAC-SI in this case refers to a Current, Accurate, and Comprehensive (e.g., SOP) in a Systematic, Integrated Manner.
In this 60-min presentation, the speaker will guide you through the details of the contents for your integration in your practical and actionable SOP. At the end of the presentation, you should be able to come up with your practical, actionable, and sustainable solutions to your organizations.
About the Areas to Be Discussed
- SOPs: Definitions and Why?
- When are SOPs needed?
- Who should develop an SOP?
- Requirements in the SOPs
- Writing an effective SOP
- Contents and format of SOPs
- How to implement SOPs
- Training employees with the SOPs
- Practical, Actionable, and Sustainable Solutions (PASS)
- Speaker’s Experience and Actual Cases
About the Intended Attendee(s)
- Healthcare Business Owners
- Regulatory Affairs Professionals
- Clinical Affairs
- Senior Management
- Contractors and subcontractors
- Anyone interested in the topic
About the Seminar Speaker
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products. In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.
Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009. Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author. Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim serves as a member of the Advisory Board for inspection insider at FDA News.
- Option 1: you may send your “request to purchase” by email to Global Compliance Seminar
- Option 2: you may request an invoice by email to Global Compliance Seminar
- Option 3: you may purchase online below using a credit card or PayPal.
LIVE (one attendee): $199
LIVE (≤ 5 attendees): $599
LIVE (≥ 6 attendees): $999
LIVE & Recorded: $299