Guest Speaker: George Bernstein, Ph.D. Principal, Manufacturing Analysis Inc.
For most companies, controlled documentation consists of a patchwork of low level SOPs and work instructions across business units that perform the same work. These documents:
- may be the Result of M&A
- do not represent best practices-represent Procedures that are inconsistent in format, content, and in some cases overlap and conflict with other procedures, or leave gaps
- can become a compliance issue
- can add cost through redundant efforts to write/revise across sites
- provide greater opportunities for documentation errors, deviations
By creating quality standards, companies can:
- realign quality-related documentation
- base quality standards on international standards (e.g., FDA, OECD, EMEA, ICH)
- implement across businesses
- quality standards form basis for restructuring and rewriting of SOPs
Quality Standards - Your Ticket to Comprehensive SOP Coverage and Compliance, will reveal
- What quality standards look like
- How to position quality standards within the organization
Watch this webinar to learn the benefits of Quality Standards such as:
- Alignment to national/international standards (e.g., FDA, ICH, ISO, EMEA, OECD)
- Elimination of overlap-Elimination of gaps
- Guidance to SOP authors as to scope and references
Your Speaker: Dr. Bernstein has consulted with and held positions of increasing responsibility with major pharmaceutical companies. As a consultant, Dr. Bernstein created the concepts and developed a proprietary Electronic Batch Record (EBR) system, a system that is still in use after 9 years. Dr. Bernstein has lectured on root cause analysis to industry trade groups, quality organizations, and at Interphex, and has consulted internationally.