Global Compliance Trainings, 201,N Squirrel road, Suite 1007, Auburn Hills, Michigan United States - 48326.
28-04-2014
Webinar Description :
The FDA and its European counterpart, EMA, require drug manufacturers to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance and state of control. This program provides the foundation for an efficient and effective batch record review process and provides pharmaceutical companies with two strategies. First, the key to recognizing what your firm needs to demonstrate control of your manufacturing operations. And, secondly, how to put into place a proactive training regime and batch record review management system. Objectives of the Presentation: - Identify the regulatory requirements of the master and batch production control record
- Recognize the regulatory requirements and expectations of the batch record review process
- Value the roles, responsibilities and training for the batch record review process.
Areas Covered: - Regulatory requirements for batch record review
- Skills and responsibilities of an effective batch record reviewer
- Tools for effective batch record review
- Production and Quality reviewers
- Training plan for batch record reviewers
Who will benefit: quality assurance batch record reviewers production personnel who are responsible for batch record reviews QA managers and supervisors of batch record reviewers Why you should attend: Too often, QA managers tell their batch record reviewers, “Here’s a batch record…review it and let me know it’s okay in a couple of hours…” While this is being said, they’re thinking - how hard can it be. This is done without recognizing the many facets of the batch record review process. This program presents those facets from the regulatory requirements for batch records and batch record review (for both the FDA and EU) through a technical review of batch records. In this course you will discover the essentials of batch record reviewer qualifications and training, promote confidence in determining review decisions or recommendations, and outline how to establish a working relationship between production and quality reviewers. Instructor Profile Kerry Potter gained his API and finished pharmaceutical manufacturing experience during his 28-year career with Merck. His career spanned the areas of Quality Operations, Audits & Inspections, Laboratory, Human Resources, and Learning & Development. More specifically, his responsibilities included implementation of the FDA Quality Management System, GMP training (annual, ongoing, new hire), and OSHA regulations and Process Safety Management training, as well as the management of site quality performance, internal communications and external public relations. Kerry serves as president of Summit Consulting, Inc. (a Virginia-based corporation) and provides a combination of business and hands-on consultation, training and mentoring services for the pharmaceutical manufacturing industry. This combination is founded on his experience and service in the areas of project management of regulatory compliance and quality systems; quality assurance; quality systems audits; laboratory testing; design and presentation of regulatory training; employee development; GMP and documentation; and regulatory agency interaction and communication. He is currently supporting clients with Quality Systems and training system remediation efforts for pharmaceutical manufacturing, and facilitates public and private training seminars on regulatory compliance topics, both domestically and in Europe. Live Session for one participant Price: $225.00 Corporate Live Session 4 to 10 participants in single location. Price:$885.00 Recorded Session Access recorded sessions only for one participant unlimited viewing for 6 months. Price: $275.00
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