This program is specially designed for personnel in the Pharmaceutical and Biotechnology industries.
This guidance provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. These aspects include development, manufacturing, distribution, inspection, and submission/review processes throughout the lifecycle of drug substances, drug products, biological and biotechnological products (including the use of raw materials, solvents, excipients, packaging and labeling materials in drug products, biological and biotechnological products) Detail review of Quality Risk Management as Part of Production and
Validation.
Areas Covered in the seminar:
- Understand why the use of Risk Management in Process Validation is now expected.
- What does the FDA expect for batch conformance prior to, and post, product approval .
- What is the benefit of using the Risk Management approach versus the traditional 3 batch validation approach?
- What does ICH Q9 mean with respect to Quality Risk Management in Validation.
- Learn why the Quality Risk Management approach to Validation will result in less ongoing process support during production.
Who will benefit:
This program is specially designed for personnel in the Pharmaceutical and Biotechnology industries with daily responsibilities in the:
- Quality Assurance
- Regulatory Affairs
- Compliance Auditing
- Validation
- Manufacturing
- Consultants
- Training
- Quality Control
- Product Submission
Instructor Profile:
Jeannette Welling, Process Validation Specialist in the Biotech industry with expertise in cleaning and manufacturing processes. Jeannette has extensive experience in the Biotech industry. She worked with Amgen, Inc., for 12 years in areas of Quality Assurance and Validation. She managed all aspects of the cleaning and manufacturing process validation program. Defined and defended process validation policies and approach.
Oversaw creation, revision, and implementation of documentation (master plans, protocols, reports) and provided training for staff. Functioned as member of the Quality Management Team to address failure investigations,
risk and gap analyses and change control assessments. She also directed the activities of staff, contractors, and ancillary team members. Prior to Amgen, Jeannette worked with Endocrine Sciences and Damon Reference Laboratory in California for over 20 years. During those years she gained extensive knowledge in numerous analytical testing and development areas.
