RIGHT FIRST TIME DOCUMENTATION TO ADDRESS BOTH COM 2016 - Right First Time Documentation – compliance and eliminating non value added actions - By Compliance Global Inc

Website https://complianceglobal.us/product/700469/WilliamBillMiller/right-%20first-time-documentation-%20co | Edit Freely

Category Education; E-Learning

Deadline: July 20, 2016 | Date: July 20, 2016

Venue/Country: online webinar, U.S.A

Updated: 2016-06-29 13:34:07 (GMT+9)

Call For Papers - CFP

Documentation is the backbone to compliance in an FDA regulated organization. We have all heard “if it isn’t documented, it didn’t happen.” Every action taken in producing pharmaceutical products must be detailed in a procedure. The deviation from these procedures can result in delays in product shipment, investigations, potential rejection of product and FDA findings of inspection.

Documentation errors resulting in the return of documents from quality for documentation correction add no value but will increase the time for the flow of product from manufacturing to approval for distribution.

A batch record can contain 100 documents each with numerous entries. Individuals complete these entries and as human beings; they can make mistakes. This can be as simple as a number transposition or as important as the documenting of a critical manufacturing step or laboratory test. The FDA understands this and allows for corrections to be made. RFT documentation refocus’ from catching errors to not making errors.

Right First Time(RFT) Documentation is a valuable tool, when correctly implemented, to ensure required actions are documented correctly, legibly and clearly. Correct documentation is manageable but not either easy or quick to implement.

Why Should You Attend:

Right First Time Documentation specifically addresses both compliance and nonvalue added actions/cycle time reduction. Implementing this program, though not easy or quick, will begin to pay dividends from the beginning.

Areas Covered in this Webinar:

This webinar will give you a process to implement RFT for FDA compliance in your organization. This will move the focus from reviewing and correcting documentation errors to having each individual who performs documentation taking responsibility for not making errors.

Learning Objectives:

The benchmarks and best practices for implementing RFT in an organization

How to determine your organizations initial documentation accuracy and the metrics to set goals and track progress

Utilizing a cross sectional team to implement RFT

Learn how to Manage the change to RFT in your organization

Determining the costs versus benefits of RFT

Why accountability is the key to RFT implementation

Who Will Benefit:

Site Leaders/Plant Managers

Directors of Quality and Manufacturing

Manufacturing Supervisors and Managers

QA, QC Supervisors and Managers

Maintenance Supervisors and Managers

Laboratory Managers and Supervisors

For more information, please visit : https://complianceglobal.us/product/700469/WilliamBillMiller/right-%20first-time-documentation-%20compliance-and-eliminating-non-%20value%20-added%20-actions/1

Email: supportcomplianceglobal.us

Toll Free: +1-844-746-4244

Tel: +1-516-900-5515

Level:

Intermediate

Speaker Profile:

William (Bill) Miller a Principal at Black Gold Gray Consulting. With more than 35 years of GMP Manufacturing, Bill has held manager/director positions in Quality Assurance, Manufacturing, Packaging, Purchasing, Distribution and Plant Management.His focus has been turning around organizations

Most recently as Plant Manager at Ohm Laboratories Gloversville, New York facility –Led a successful FDA Warning Letter remediation. Reorganized the site for productivity and compliance by hiring and training 90% new staff. Instituted and instilled culture of compliance and accountability, resulting in a site prepared for a smooth return to production.

Recognized for his mentoring of individuals in supervision and management in the military, Johnson and Johnson, Lederle Labs, Alpharma, Biersdorf and Pfizer.

Founded Black Gold Gray Consulting to provide hands on guidance to pharmaceutical and over the counter manufacturers with a focus on remediation, compliance, supervision and team building. Comfortable from the production floor to the board room, he is an outstanding communicator and trainer.

Bill earned a BS in Engineering at the United States Military Academy, West Point, New York.