This webinar will utilize ISO 19011:2011, ICH Q10 and FDA guidances and explain how to conduct an effective internal audit program.
Attendees will learn the benefits of a well-designed and executed internal auditing program, an overview of various cGMP regulations and how to reinforce their quality system, along with potential efficiency enhancements.
Due to the growing importance of regulatory compliance, the increasing international harmonization, and the potential consequences, many pharmaceutical manufacturers have adopted a program of internal audits to find and correct areas where the facility is not in full compliance with the cGMP regulations. This allows corrections before a regulatory body audit.
Learning Objectives:
- The need, purpose, cost and benefits
- Principles of auditing
- Establishing, Implementing and managing a quality audit program
- The audit cycle - initiating, preparing, conducting, reporting, the wrap up, and follow up
- Auditor competence evaluation - practice, behavior, knowledge and skills
- Auditor evaluation - criteria, evaluation methods, improving
Why Should You Attend:
Pharmaceutical and medical device companies are legally bound to ensure that regulated quality compliance standards are consistently maintained, with potentially severe business and legal consequences for certain failures.
Regular internal audits are the
best practice to meet and maintain
compliance in changing manufacturing and
regulatory environment before a potential
critical discovery by an FDA audit. This is
also a smart practice to improve
efficiencies, especially during a product
life-cycle.
This webinar will review this process
and discuss best practices of an effective
internal auditing program, and how to add
overall value to the company.
Areas Covered
- Regulatory expectations and rights
- Expectations and benefits of good program and auditing
- How to design and conduct an objective and effective audit
- Auditing of business structure, facilities, personnel, records, laboratories, environment and validation
- Effective management interaction and communication
- The report and follow-up
Instructor
Larry Stevens is a
pharmaceutical science consultant focusing
on strategic product development, quality
and regulatory compliance. This
encompasses quality by design, gap and
risk analysis, experimental analytics, and
the development and validation of methods,
processes and environments.
He has extensive experience working for both large and small pharma companies and successfully working with a wide range of product types. Product development accomplishments include the strategic design of controlled release suspensions and the first orally disintegrating tablet on the market.
Other accomplishments include the development and validation of hundreds of analytical methods, along with instrument, software, process and cleaning validations, SOPs, and successful CMC submissions.
The author of numerous articles, an internationally recognized speaker and conference chair, and a recipient of the Alcon Laboratories research award, Larry now consults in strategic quality product and analytical development, successfully meeting needed regulatory compliance requirements.
He has extensive experience working for both large and small pharma companies and successfully working with a wide range of product types. Product development accomplishments include the strategic design of controlled release suspensions and the first orally disintegrating tablet on the market.
Other accomplishments include the development and validation of hundreds of analytical methods, along with instrument, software, process and cleaning validations, SOPs, and successful CMC submissions.
The author of numerous articles, an internationally recognized speaker and conference chair, and a recipient of the Alcon Laboratories research award, Larry now consults in strategic quality product and analytical development, successfully meeting needed regulatory compliance requirements.