GMPs for API Bulk Manufacturers

Till recently, till 2001 that is, Good Manufacturing Practices for Active Pharmaceutical Ingredients (APIs) bulk manufacturers was carrying a bulky load on its shoulders, so to speak. GMP for active pharmaceutical ingredients (APIs) per se had no independent guidelines. The GMPs that they were to follow and implement were bunched with those of APIs for bulk manufacturers. So, GMPs for API bulk manufacturers consisted of GMPs for both APIs and API bulk manufacturer.

All that changed, however, in 2001, with the FDA’s issuance of a draft guideline called Q7A, which was meant separately and exclusively for APIs alone. This draft guideline was meant solely for APIs, and GMPs for API bulk manufacturers were exempt from the provisions of the new guideline.

No clear guideline yetThat said, while the FDA draft guidance of 2001 merely separated GMPs for APIs; it did not make any changes to the existing GMPs for API bulk manufacturers, which continued to remain the same and continued to suffer the same insufficiency. The major deficit that plagued GMPs for API bulk manufacturers continued to do so. As in the past, there was no guideline on GMPs for API bulk manufacturers at all. Instead, all that was required was that bulk manufacturers go by their heart. In other words, the onus of maintaining GMPs for API bulk manufacturers was left to them, based on their unique individual needs and situations.

Leaves it to the individual pharma organizationThe FDA and other regulatory bodies merely require that established practices be followed as GMPs for API bulk manufacturers. This, as noted, leaves the task of ensuring that conception and implementation of all-round GMPs for API bulk manufacturers to the individual organization, based on its discretion and assessment of what it deems as appropriate. The following are the areas into which pharmaceutical organizations may take steps at implementing GMPs for API bulk manufacturers:

  • Manufacturing equipment
  • Components that go into the materials and packaging
  • Requirements relating to record-keeping
  • Facilities and buildings
  • Personnel
  • Process controls
  • Laboratory controls

Learn more on this topic for your reference: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900964SEMINAR?Linkedin-SEO

Supplier Management Conference for Medical Device Manufacturing in HONG KONG

 

Overview:

Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment.

How well do you understand the requirements for supplier management?

Could you pass a regulatory audit or inspection without any issues?

This course delivers the tools, templates, and methods to help participants implement an effective and efficient supplier management program.

This two-day hands-on course provides a clear understanding of the underlying principles of supplier management. The course uses exercises to solidify understanding. In addition, the course uses FDA Warning Letters to illustrate the points and help you learn from others. As part of the practical implementation, the course includes receiving acceptance activities, outsourced processes, process validation at the suppliers’ location, supplier auditing techniques, and supplier issues in management review.

The course uses the Global Harmonization Task Force (GHTF) framework, but expands it to cover other issues and techniques important in effective implementation.

Why should you attend:

Since FDA regulations do not allow them to audit your suppliers unless they make finished medical devices, they require that you have sufficient control over them. But from time to time the FDA makes a reinterpretation of what this means. This happened within the last f 5 years, so if you supplier management program is older than that, you need to make major changes in you supplier management program. This is why the Good Manufacturing Practice (aka Quality System Regulations) is called cGMP. The C stands for current, meaning what the FDA considers the current state of the art in the areas they regulate. Also European Notified Bodies also periodically update their expectations, and for suppliers this happened with the publication of a guidance document by the Notified Body Operations Group (NBOG).

This seminar will go into the details of the NBOG supplier guidance document and a GHTF (Global Harmonization Task Force) guidance that describes the current FDA expectation on supplier management.

One of the major things introduced in these guidance document, is the concept of Risk, and the use of identified risks as part of the evaluation and monitoring of suppliers.

This seminar will review requirements and expectation of the FDA and European Notified Bodies for supplier management, and then how to incorporate these into your own supplier management process.

Areas Covered in the Session:

  • Understand FDA QSR and ISO 13485 requirements for supplier management
  • Creating a Risk-based Multi-tier supplier classification system
  • Understand when suppliers have to register and list with the FDA
  • Defining and using supplier Metrics
  • Explain the link between design control and purchasing data
  • Develop an risk-based supplier management process
    • Incorporating supplier regulatory and safety risk
    • Incorporating supplier business risk
  • Create supplier measurement and monitoring systems
  • Understand the how to develop and implement supplier controls
  • Create a risk based Value-added system for supplier audits
  • How to prepare yourself and your contract manufacturer for unannounced audits from your Notified body
  • Creating acceptance criteria and understand how that fits into your supplier control process

Who will benefit:

  • Quality Managers
  • Quality Engineers
  • Audit Managers
  • Supplier Engineers
  • Internal quality auditors
  • Supplier auditors
  • Quality associates
  • Quality Specialists
  • Regulatory Compliance Managers

Agenda:

Day 1 Schedule

Lecture 1:

Introductions

Lecture 2:

Fundamentals Regulatory Requirements

  • FDA Requirements
  • ISO 13485 requirements
  • Understanding the role of the Global Harmonization Task Force Guideline
  • Understanding NBOC Guideline and why it should be used

Lecture 3:

Planning the Supplier Management Program

  • Supplier Classification
  • Supplier QA agreements what are they and why are then

Day 2 Schedule

Lecture 1:

Planning Supplier Selection

Lecture 2:

Potential Suppliers

Lecture 3:

Supplier Selection

Lecture 4:

Implementing Supplier Controls

Lecture 5:

Monitoring, Measuring, and Evaluation

  • Periodic Monitoring
  • Re-evaluations

Lecture 6:

Supplier Audits – where do they add value

  • Planning your supplier audit schedule
  • How Notified Body unannounced audits affect your contract manufacturer
  • What you should do to prepare yourself and your contract manufacturer for unannounced Notified body audits

Lecture 7:

Feedback and Communication

  • Supplier meetings: Partnering with Key suppliers
  • Supplier Corrective Actions

Lecture 8:

Evaluating your current program to see how it measures up to regulatory Expectations

Speaker:

Betty Lane,

Founder and President, Be Quality Associates, LLC

Betty Lane has over 30 years’ experience in Medical Device quality assurance and regulatory affairs. She is the founder and President of Be Quality Associates, LLC, a consulting company helping small and medium sized medical device and diagnostic companies implement and improve their quality systems. Her work enables companies to manage their business in compliance with FDA and ISO 13485 requirements, as well for quality system requirements for other geographic area such as Europe and Canada. Her background in digital systems engineering enables her to facilitate quality system processes for design controls and software validation. Her areas of expertise include training, auditing, supplier management, document and records management, design controls, and software validation.

Betty’s training experience includes over 25 years of training on all aspects of ISO 13485, the ISO standard for Medical Device – Quality Management Systems – System Requirements for regulatory purposes, and FDA Quality System Regulation – Medical Devices; Good Manufacturing Practice (cGMP), in companies where she worked as manager or director, and for AAMI, ASQ biomedical division, and ASQ sections. She has taught courses in medical device and biotechnology quality and regulatory affairs as an Adjunct at Northeastern University, Boston, MA. Betty is active in her local section of the American Society for Quality and is also a member of the Association for the Advancement of Medical Instrumentation (AAMI), The Society of Women Engineers and the IEEE. Betty has degrees in engineering from Rensselaer Polytechnic Institute (RPI), and an MBA from Northeastern University.

Location: Hong Kong Date: April 6th & 7th, 2017 and Time: 9:00 AM to 6:00 PM

 

Venue: INTERCONTINENTAL HONG KONG

Address: 18 Salisbury Road, Kowloon, Hong Kong

 

Price:

 

Price: $1,695.00 (Seminar Fee for One Delegate)

 

Until February 28, Early Bird Price: $1,695.00 from March 01 to April 04, Regular Price: $1,895.00

 

Register for 5 attendees   Price: $5,085.00 $8,475.00 You Save: $3,390.00 (40%)*

 

Quick Contact:

NetZealous DBA as GlobalCompliancePanel

 

Phone: 1-800-447-9407

Fax: 302-288-6884

Email: support@globalcompliancepanel.com

Website: http://www.globalcompliancepanel.com

Registration Link – http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900878SEMINAR?channel=mailer&camp=seminar&AdGroup=wordpress_April_2017_SEO

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Medical products need to be validated for Radiation Sterilization

Do it right the first time” should be the mantra for medical device manufacturers that plan to make radiation products. Choosing the most functional and radiation resistant materials for their medical device will help them avoid the trouble of going through the post launch cycle of product revisions.

validation1

To get this right, one simple line of thinking is crucial for medical device manufacturers to inculcate: To “think like a molecule”. This is the basis on which to plan and design around radiation induced changes in the qualities such as color, odor and brittleness that go into the materials.

Learning the right method

Professionals in the medical devices industry, who work on these aspects will benefit immensely from a two-day seminar on the topic, “Validating Radiation Sterilization for Medical Products”, which is being organized by GlobalCompliancePanel, a highly popular provider of professional trainings for all areas of regulatory compliance.

compliancecorpprograms

The Director of this seminar, Karl J. Hemmerich, President of Ageless Processing Technologies, who brings over 35 years of experience in medical device product design, development, manufacturing, and sterilization, will offer a range of learning on this topic.

Identifying the best suited materials

Apart from helping participants identifying the materials that perform best upon radiation, keeping color and odor out of their irradiated products and enhancing product and packaging designs to take advantage of radiation; he will also offer understanding to them on how to avoid the materials that are certain to fail.

This seminar, for which medical device professionals can enroll by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900685SEMINAR?validating-radiation-Washington-DC, has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Understanding optimum sterilization modality

Participants will also learn the basis for choosing the optimum sterilization modality based on materials, product design, bioburden, and logistics and understand which modality (Gamma, E-beam, or X-ray) will perform best for their product.

Karl will cover the areas relating to validation of radiation sterilization for medical products, such as Materials Guidances – AAMI TIR # 17, ASTM, sterilization validation and bioburden, Shelf Life Test Methods – Accelerated Aging design, Test Design, Product Design, the influences of product assembly (molding, automation, etc.), material selection and post irradiation degradation, Regulatory Guidances – AAMI/ISO 11137, TIR #17, packaging design and materials, and biological polymers – tissue, serum at this two-day in person seminar.

The following areas will be covered at this seminar:

  • Polymers Chemistry – choosing the best polymer candidate
  • Gamma, E-beam, X-ray sterilization
  • Accelerated Aging
  • Product Qualification
  • Sterilization Validation – Establishing the Minimum Sterilization dose (VDmax)
  • Sterilization Modality Selection Criteria
  • Biocompatibility
  • Preventing Plastic Part Failure Post Irradiation