Supplier Management for Drugmakers: Qualification, Contracts and Audits

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As a successful drugmaker, you know there’s no passing the buck to suppliers and vendors when it comes to meeting regulatory requirements.

You must choose suppliers wisely and exercise careful oversight. The expert contributors to Supplier Management for Drugmakers will enable you to do just that. They share how to pick the highest-quality and most reliable firms and how to hammer out a contract that will hold the supplier to your standards.

Supplier Management for Drugmakers covers the three phases of working with suppliers and vendors:

·Qualification section — you’ll understand how to evaluate prospects and score them on the most important factors, including communication, compliance, facilities, logistics and price.

·Contracts section — you’ll know the 24 elements to cover in any supplier agreement, including technical transfer, change control, deviation handling, complaint management, quality review and records retention.

·Supplier auditing section — your four-part plan will enable you to decide the who, what, when and how of overseeing your contractors, including conducting for-cause audits, qualities of an effective auditor and how to write effective audit observations.

Supplier Management for Drugmakers: Qualification, Contracts and Audits will help you maintain quality and improve compliance in upgrading your supplier management skills by:

·Understanding core competency areas on which to evaluate suppliers

·Determining what constitutes due diligence in researching suppliers

·Scoring and comparing suppliers

·Creating a certified supplier list

·Ascertaining how much advance notice of an audit to give a supplier

·Developing a risk-assessment methodology

·Recognizing the differences among system audits, procedure/process audits and product audits

·Knowing when and how to conduct a remote audit.

Enhance your supplier management skills and pick the right supplier, craft the best contract and perform audits with Supplier Management for Drug makers: Qualification, Contracts and Audits. Register today.

Who Will Benefit:

·Quality unit professionals

·Vendor relations personnel

·Legal personnel

·Regulatory professionals

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Speaker: Michael C Redmond, CEO and Lead Consultant, Redmond Worldwide

Dr. Michael C. Redmond, PhD, is a certified project manager, PMP, has two master certifications in business continuity/disaster recovery MBCP and FBCI and is certified in emergency management. She is active in cyber security and holds multiple ISO certifications (ISO/IEC 27001 Information Security Management, ISO/IEC 27032 Lead Cyber Security Manger, ISO/IEC 27035 Security Incident Response, ISO/IEC 22301 Business Continuity Management Systems, ISO/IEC 21500 Project Management, and ISO/IEC 41001 Environmental Management). She is an international consultant, speaker and published author.

Her past experience includes 13 years as a senior manager with Deloitte, KPMG and Chubb in the areas of: compliance, crisis management, business continuity, disaster recovery, emergency management, internal audit/ gap analysis. She was a business continuity/disaster recovery manager with the Bank of New York. She consults for clients in diverse industries such as banking, manufacturing, pharmaceutical, hospitals, government agencies, colleges and universities, law firms, and media.

Dr. Redmond spent 4 years on active duty with the army and 18 1/2 years as National Guard and Reserve before retiring as a major. She is a graduate of Command & General Staff College (Fort Leavenworth), attended civil affairs courses at the US Army JFK School of Special Warfare and is Hazmat trained and DOD certified. The White House honored Dr. Redmond at a luncheon as one of the Top Women in Her Field of Business Continuity.

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