Risk Based Approach in cGMP - Quality Risk Management (QRM)

Why Should You Attend:

Quality Risk Management (QRM) is a systematic process for the assessment, control, and communication and review of risks to quality of the drug product across the product lifecycle. Risk-based compliance is expected by regulatory agencies and strongly recommended by industry to balance compliance efforts and costs vs. product quality and patient safety. Risk management has a long history in the industry. FDA’s current thinking, Guidance for Industry – Q9 Quality Risk Management and ICH are available for reference which discuss areas of risk management yet the topic remains underutilized in industry.

QRM is a management concept that is passed on to employees by the management and decision makers in a company.

Attendees will gain a broader understanding of QRM and how to effectively apply these concepts within respective organizations.

Areas Covered in the Webinar:

• Review background information on risk management in industry
• Provide information and points to aid in the understanding of the quality risk management concept
• Review how risk management can be applied in pharma manufacturing industry
• Review specifics of ICH Q8, Q9, and Q10 guidelines on interworking throughout product lifecycle.
• List significant definitions and terms

Who Will Benefit:

This webinar will benefit professionals in medical device, pharmaceutical, biologics and biotechnology industries, functioning in departments such as manufacturing, quality, labeling, packaging and distribution. The employees who will benefit include:

• Department managers and supervisors
• QA/QC/ specialists and engineers
• Regulatory affair personnel
• R&D engineers
• Scientists
• Documentation specialists
• Auditors

Shana Dressel
Senior Consultant, The Compliance Edge LLC

Shana Dressel is a highly proficient and accomplished leader in quality assurance with over 17 years of experience within FDA regulated industries, clinical development through large scale manufacturing (GXP), including large and small molecule drugs, medical devices, and dietary supplements.

Shana is the founder of The Compliance Edge consulting company established in 2006 which partners with industry’s elite drug and medical device manufacturers, providing guidance in regulatory, quality and compliance situations with extensive experience in all phases of drug/device development and manufacturing. She possesses extensive experience in company leadership, quality management, client interaction, regulatory inspection management, supplier management, and GXP auditing.

Topic Background:

All employees, especially the management and decision makers of a pharmaceutical/medical device company who bear responsibility for the effectiveness of the process and resulting quality of the product should develop a risk-based sensitivity in their day-to-day behaviour, and QRM should enable them to identify risks, and monitor, manage and control them in an appropriate way.

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