Regulatory requirements on pharmaceutical packaging materials from US and EU points of view

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Areas Covered in the seminar:

• Description: for each packaging component Name, manufacturer, physical description, Materials of construction (plastic, glass, metal, glass and etc), Additional operation or preparation (washing, sterilization and depyrogenation).
• Suitability: for the intended use
• Protection
  • Light exposure
  • Reactive gases (e.g. oxygen)
  • Moisture permeation (powders)
  • Solvent loss (liquid-based dosage form)
  • Sterility (container/closure integrity)
  • Seal integrity or leaking
• Safety
  • Chemical composition of all plastic, elastomers, adhesives, etc. and Extractables : extraction/toxicological evaluation studies per USP Testing. Appropriate reference to indirect food addtivie regulation (21 CFR 174-186).
  • Other studies as appropriate
• Compatibility: for each components or system
  • Component/dosage form interaction: USP methods are accepted
  • Post approval Stability studies support
• Performance: for assembled packaging system
  • Functionality and/or drug delivery
• Quality Control
• Applicant:
  • Test results and acceptance criteria
  • Dimensional (drawing) and performance criteria
  • Method to monitor consistency in composition of most plastic and elastomeric components (comparison of original extraction profile, for example).
• Supplier
  • Manufacturer’s acceptance criteria for release
  • Description of the manufacturing process if additional preparation or treatment is performed (sterilization and depyrogenation)
• Stability: data should be provided in the intended commercial packaging and closure system according appropriate stability protocols.

Who will benefit:

This webinar will provide valuable assistance to all personal in the Pharmaceutical, Biotechnology, Device industries.All Pharmaceutical, Device and Biotechnology companies. Personnel from the following functional areas will benefit from this course:

• Manufacturing/Operation Packaging
• Quality Assurance
• Quality Control
• Quality Audits
• Validation
• Regulatory Compliance
• Process Development
• Analytical Development
• QA / Vendor Audit
• Training

Instructor Profile:

Paul Chen,Ph.D is a Sr. Consultant with PQC Consulting, Inc. and has over 30 years of experience in pharmaceutical and biotechnology industries in the areas of R&D, Quality Control, Quality Assurance and Regulatory Affairs. Dr. Chen recently retired from Amylin Pharmaceuticals, Inc. where he was Director of Regulatory Affairs with an emphasis in Chemistry, Manufacturing and Controls (CMC). Previously, Dr. Chen held positions with increasing responsibilities at Pfizer, Agouron, Warner-Lambert, American Home Products and Boehringer-Ingelheim.

Dr. Chen’s functional areas of expertise include analytical methods and specifications development, raw material and finished product testing and release, formulating regulatory strategy and guidance for drug development and maintenance after approval, preparation of common technical documents (CTD), IND/CTX, NDA/MAA, Annual Reports, DMF and comparability protocols. He was responsible for the CMC sections of six approved NDAs, three approved MAAs and numerous supplements and amendments in the therapeutic areas of anti-infective, antiviral, cardio-renal, anti-hypertensive, neuropharmacology, diabetes and obesity.

Dr. Chen has also participated in a number of FDA PAIs. Dr. Chen received his B.S. degree from National Taiwan University and M.S. and Ph.D. in biochemistry from North Carolina State University and a Post-Doctoral Fellowship with NIH. He is a member of the American Chemical Society, American Association of Pharmaceutical Scientist and Drug Information Association.

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